Registered Ongoing Studies

Effects of 5HTP and LDOPA on CNS Excitability After SCI

This study will examine whether supplementation with the serotonin and dopamine precursors, 5HTP and L-DOPA can alter central nervous system excitability and improve motor function after incomplete and complete spinal cord injuries.

First Posted: 2019-06-27

Condition(s): Spinal Cord Injuries

Intervention(s): 5HTP, L-DOPA, Placebo oral tablet, Carbidopa

Status: SUSPENDED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Jessica M D'Amico

Principal Investigator: Jessica M D'Amico, Assistant Professor

Completion Date (primary or actual): 2023-12-30

CT.gov Identifier: NCT04000919

Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

This study will integrate and adapt a cognitive remediation (Cognitive Enhancement Therapy \[CET\]) and an affect regulation (Personal Therapy \[PT\]) intervention for 50 individuals with schizophrenia that misuse cannabis. Participants will be randomized to CET/PT plus treatment as usual (TAU) or TAU alone and treated for 18 months.

First Posted: 2011-02-09

Condition(s): Schizophrenia, Schizoaffective Disorder

Intervention(s): CET/PT, Treatment as Usual

Status: COMPLETED

Enrollment (expected or actual): 33

Allocation: RANDOMIZED

Sponsor: University of Pittsburgh

Principal Investigator: Shaun M. Eack, Professor of Social Work and Psychiatry

Completion Date (primary or actual): 2014-09

CT.gov Identifier: NCT01292577

The Impact of Opioid and Cannabis Exposure on Fetal Growth

Individually, both opioid and cannabis exposure during pregnancy are associated with changes in fetal growth. The extent to which opioid and cannabis exposure affect fetal growth is unknown. The Investigators hypothesize that the combination of both substances will impact placental function and subsequent fetal growth more severely than either substance alone. The primary objective is to determine the extent to which fetal growth profiles in opioid-exposed pregnancies are influenced by cannabis exposure. This prospective cohort study will consist of opioid-exposed pregnancies and pregnancies without opioid exposure recruited from 5 obstetrical clinics from across Ontario. A total of 546 participants will be recruited.

First Posted: 2023-06-12

Condition(s): Pregnancy Related, Substance Use, Fetal Growth Retardation, Placenta Diseases

Intervention(s):

Status: TERMINATED

Enrollment (expected or actual): 20

Allocation:

Sponsor: Dr. Laura Gaudet

Principal Investigator: Dr. Laura Gaudet, Associate Professor

Completion Date (primary or actual): 2024-11-30

CT.gov Identifier: NCT05899101

An Open Label Study of Multiple Doses of Cannabidiol in the Prevention of Acute Graft-Versus-Host Disease (GVHD)

A prospective, open-label, phase 2a study, to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of multiple doses of Cannabidiol (CBD) in participants Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT)

First Posted: 2019-02-15

Condition(s): Prevention aGVHD

Intervention(s): CBD

Status: UNKNOWN

Enrollment (expected or actual): 36

Allocation: NON_RANDOMIZED

Sponsor: Kalytera Therapeutics Israel, Ltd.

Principal Investigator:

Completion Date (primary or actual): 2022-12-15

CT.gov Identifier: NCT03840512

A Mobile Phone Self-Monitoring Tool to Increase Emotional Self-Awareness and Reduce Depression in Young People

The mobiletype program is a mental health assessment and monitoring tool that runs on mobile phones. The program assesses the general mental health of young people in real-time and transmits this data to a website to be reviewed by their general practitioner (GP) in consultation with their patient. The website consists of individualised feedback reports for each participant, and graphical displays of the monitoring data. The primary aims of the current project are to examine: (1) whether the process of self-monitoring via the mobiletype program increases young people's awareness of their mood and reduces depressive symptoms and (2) whether emotional self-awareness mediates the relationship between self-monitoring and depressive symptoms.

First Posted: 2008-11-20

Condition(s): Depression

Intervention(s): Mobile Tracking Young People's Experiences (mobiletype)

Status: COMPLETED

Enrollment (expected or actual): 118

Allocation: RANDOMIZED

Sponsor: Murdoch Childrens Research Institute

Principal Investigator:

Completion Date (primary or actual): 2011-01

CT.gov Identifier: NCT00794222

Nabilone for Agitation Blinded Intervention Trial

This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority. Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting. The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice. Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.

First Posted: 2020-08-17

Condition(s): Alzheimer Disease, Agitation

Intervention(s): Nabilone, Placebo

Status: RECRUITING

Enrollment (expected or actual): 112

Allocation: RANDOMIZED

Sponsor: Sunnybrook Health Sciences Centre

Principal Investigator:

Completion Date (primary or actual): 2027-04

CT.gov Identifier: NCT04516057

Full-spectrum Medical Cannabis for Treatment of Spasticity in Patients With Severe Forms of Cerebral Palsy

The proposed study is a double-blind, placebo-controlled, cross over study on 60 children aged 5 to 25 years with severe spasticity related to cerebral palsy (CP), level IV and V with full-spectrum medical cannabis product of CBD/THC ratio 10:1.

First Posted: 2020-11-18

Condition(s): Children, Adult, Spastic Cerebral Palsy, Quality of Life, Cannabis, Physical Disability

Intervention(s): Lab tests, ECG, Cannabinoid Levels, Full-spectrum Medical Canabis Product (HemPhar), Placebo, Spasticity level according to modified Ashworth scale (Bohannon), Gross Motor Function Measure, Borg rating of perceived exertion scale, Edmonton symptom assessment system

Status: COMPLETED

Enrollment (expected or actual): 55

Allocation: RANDOMIZED

Sponsor: University Medical Centre Ljubljana

Principal Investigator: Damjan Osredkar, Associate Professor of Pediatrics

Completion Date (primary or actual): 2024-02-29

CT.gov Identifier: NCT04634136

High and Low Dose Carbidopa Treatment of Parkinson's Disease

Hypothesis: We hypothesize that carbidopa in daily doses of 450mg will enter the central nervous system and partially inhibit AAAD, thereby reducing the decarboxylation of exogenous levodopa to dopamine, and thereby blunt the therapeutic effects of levodopa in PD subjects. The purpose of this study is to see how low dose vs. high dose of the study drug, carbidopa effect movement in subjects with Parkinson's disease. The low dose of the study drug is 75 mg and the high dose is 450mg. Subjects will be recruited from the investigators clinic when they are seen for treatment for Parkinson's disease. Subjects will also be recruited through flyers hung at OHSU and at the VA. Subjects will take part in 2 screening visits one week apart to determine eligibility. Subjects will be randomly chosen to start either high or low dose carbidopa and take it for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this dose of study drug. We will leave them a message if we cannot reach them. If there are any problems, we will schedule them to come to the clinic within the next 2 days. Subjects will have an outpatient visit 2 weeks after screening and a hospital admission 2 weeks after that. At the hospital, subjects will stay for 3 days. They will have blood drawn and their Parkinson's disease assessed by a finger tapping exercise, timing their walking, and looking at their uncontrolled movements. The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this dose of study drug. We will leave them a message if we cannot reach them. If there are any problems, we will schedule them to come to the clinic within the next 2 days. The outpatient visit and hospital admission will repeat again. At the end of the second hospital admission, treatment on the study is over and subjects will go back to their original Parkinson's disease medications. The study will end with a follow up phone call or clinic visit 2 - 4 weeks after the final hospital admission. Subjects will fill out a daily diary that asks about their movement throughout the day for 3 days before they come to the Oregon Clinical and Translational Research Institute. Carbidopa is used for the treatment of Parkinson's disease with levodopa. This protocol is using a high dose of 450mg of carbidopa. This study is also using IV levodopa, which is a different route than is normally given. Finger tapping rates will be compared between high and low dose study drug use to see if one group has slower rates than the other.

First Posted: 2011-07-22

Condition(s): Parkinson's Disease

Intervention(s): carbidopa

Status: COMPLETED

Enrollment (expected or actual): 14

Allocation: RANDOMIZED

Sponsor: Oregon Health and Science University

Principal Investigator: John G. Nutt, Director, Parkinson Center of Oregon

Completion Date (primary or actual): 2011-05

CT.gov Identifier: NCT01399905

Feasibility of Cannabidiol for the Treatment of Long COVID

This is an open label, phase 2 clinical trial to assess the feasibility of a cannabidiol (CBD) dominant medicinal cannabis for the treatment of Long COVID. The primary aim is to assess the feasibility of recruiting and retaining individuals diagnosed with Long COVID into a treatment trial of medicinal cannabis, as well as assessing the safety and tolerability of a dominant medicinal cannabis in this population. The secondary aim is to determine the effect of a CBD dominant medicinal cannabis on symptoms associated with Long COVID.

First Posted: 2021-08-09

Condition(s): Long COVID

Intervention(s): MediCabilis Cannabis sativa 50

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: NA

Sponsor: Bod Australia

Principal Investigator:

Completion Date (primary or actual): 2023-01-06

CT.gov Identifier: NCT04997395

Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes

A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes

First Posted: 2022-08-16

Condition(s): Energy

Intervention(s): Energy Study Product Usage

Status: COMPLETED

Enrollment (expected or actual): 1427

Allocation: RANDOMIZED

Sponsor: Radicle Science

Principal Investigator:

Completion Date (primary or actual): 2023-05-24

CT.gov Identifier: NCT05502328

Treatment for Teens With Alcohol Abuse and Depression

The investigators will recruit adolescents with alcohol or cannabis abuse and clinically significant depression. All participants will receive 12 sessions of an evidence-based treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12, over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to receive treatment augmentation with either an integrated cognitive behavior therapy for depression, delivered by their study therapist, or depression treatment-as-usual in the community. The study hypothesis is that integrated depression treatment will surpass community treatment-as-usual in efficacy.

First Posted: 2014-08-28

Condition(s): AOD Use, Abuse, and Dependence, Depression

Intervention(s): MET/CBT-12, CBT-D, D-TAU

Status: COMPLETED

Enrollment (expected or actual): 103

Allocation: RANDOMIZED

Sponsor: Duke University

Principal Investigator:

Completion Date (primary or actual): 2020-01-03

CT.gov Identifier: NCT02227589

Cannabis Association With Sleep Study

The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.

First Posted: 2025-05-21

Condition(s): Sleep

Intervention(s): Manipulation of Sleep Duration

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Oregon Health and Science University

Principal Investigator: Nicole Bowles, Assitant Professor

Completion Date (primary or actual): 2032-06-30

CT.gov Identifier: NCT06982950

Effects of CBD Oil on Memory Reconsolidation and Trauma-Related Symptoms

The purpose of this study is to investigate the effects of cannabidiol (CBD) broad-spectrum oil on memory reconsolidation (memory storage) and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm.

First Posted: 2023-06-07

Condition(s): Posttraumatic Stress Disorder

Intervention(s): Trauma Memory Reactivation, Cannabidiol (CBD) Broad-Spectrum Oil, Placebo Oil

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: University of Texas at Austin

Principal Investigator: Michael J. Telch, Professor of Clinical Psychology

Completion Date (primary or actual): 2025-08-31

CT.gov Identifier: NCT05892276

Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions

Randomised comparison of Culotte technique versus "Double Kissing" - Crush technique (DK-Crush) for the percutaneous treatment of de novo non-left main coronary bifurcation lesions with modern everolimus-eluting stents (DES) - German multicenter study

First Posted: 2019-12-10

Condition(s): Coronary Stenosis, Stent Stenosis

Intervention(s): Stenting

Status: UNKNOWN

Enrollment (expected or actual): 400

Allocation: RANDOMIZED

Sponsor: University Heart Center Freiburg - Bad Krozingen

Principal Investigator: Dr. Miroslaw FERENC, Director of interventional cardiology department

Completion Date (primary or actual): 2023-12-31

CT.gov Identifier: NCT04192760

Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET

The aim of the present study is to conduct a human trial of \[C-11\]OMAR, a new PET imaging agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and binding characteristics.

First Posted: 2012-11-01

Condition(s): Obesity, Alcohol Dependence, High Stress

Intervention(s): [C-11]OMAR

Status: COMPLETED

Enrollment (expected or actual): 74

Allocation:

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): 2014-05

CT.gov Identifier: NCT01719497

A Clinical Trial of SBIRT Services in School-based Health Centers

The purpose of the study is to examine the comparative effectiveness of a computerized brief intervention vs. an in-person brief intervention delivered by a nurse in reducing marijuana, alcohol, and sex risk behaviors in adolescents receiving services in school-based health centers.

First Posted: 2015-03-13

Condition(s): Marijuana Use, Alcohol Consumption, Unsafe Sex, Risk Behavior

Intervention(s): Brief in-person motivational intervention, Computerized Brief Intervention

Status: COMPLETED

Enrollment (expected or actual): 300

Allocation: RANDOMIZED

Sponsor: Friends Research Institute, Inc.

Principal Investigator:

Completion Date (primary or actual): 2018-09-11

CT.gov Identifier: NCT02387489

Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which means it affects the brain. This study will evaluate how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen. ABBV-951 is an investigational drug being developed for the treatment of PD. Study doctors randomly assign participants to 1 of 4 groups, called treatment arms. Each treatment arm receives ABBV-951 administered in a different order in the arm, high, flank and abdomen. Approximately 12 adult participants over 30 years with a diagnosis of PD will be enrolled in approximately 10 sites in the United States. Participants will receive continuous (24hours/day) subcutaneous infusion of ABBV-951 for 2 consecutive days for each infusion site (arm, thigh, flank and abdomen), for a total duration of treatment up to 12 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will be confined at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Adverse events will be monitored throughout the study.

First Posted: 2021-10-26

Condition(s): Parkinson's Disease

Intervention(s): ABBV-951

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: RANDOMIZED

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2023-03-17

CT.gov Identifier: NCT05094050

The Pharmacokinetics of a Hemp-Based Topical Product

This study will evaluate the pharmacokinetic effects of acute and chronic dosing of a hemp-based cannabidiol (CBD) topical lotion with low levels of delta-9-tetrahydrocannabinol (THC) in a sanitized and controlled environment.

First Posted: 2026-05-22

Condition(s): Cannabis

Intervention(s): CBD, THC

Status: RECRUITING

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2027-09-01

CT.gov Identifier: NCT07603518

Comparison Between Volatile Anesthetic-desflurane and Total Intravenous Anesthesia With Propofol and Remifentanil on Early Recovery Quality and Long Term Prognosis of Patients Undergoing Pancreatic Cancer and Common Bile Duct Cancer Surgery

Investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy.

First Posted: 2018-02-27

Condition(s): Pancreatic Cancer or Distal CBD Cancer

Intervention(s): Des (volatile anesthetic-desflurane), TIVA (Total intravenous anesthesia with propofol and remifentanil)

Status: UNKNOWN

Enrollment (expected or actual): 132

Allocation: RANDOMIZED

Sponsor: Yonsei University

Principal Investigator:

Completion Date (primary or actual): 2022-08-28

CT.gov Identifier: NCT03447691

Cannabis Effects as a Function of Sex

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women

First Posted: 2020-05-12

Condition(s): Pain, Abuse, Drug

Intervention(s): Active Cannabis, Placebo Cannabis

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 160

Allocation: RANDOMIZED

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor

Completion Date (primary or actual): 2027-09-01

CT.gov Identifier: NCT04385082

A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

First Posted: 2005-09-20

Condition(s): Parkinson's Disease

Intervention(s): Istradefylline (KW-6002)

Status: COMPLETED

Enrollment (expected or actual): 580

Allocation: RANDOMIZED

Sponsor: Kyowa Kirin, Inc.

Principal Investigator:

Completion Date (primary or actual): 2005-12

CT.gov Identifier: NCT00199420

AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT)

This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.

First Posted: 2021-04-26

Condition(s): Pain, Appetite Loss, Abuse, Drug

Intervention(s): Placebo, Low CBG, High CBG, Low THC, High THC

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor

Completion Date (primary or actual): 2026-12-04

CT.gov Identifier: NCT04859296

Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).

First Posted: 2012-02-24

Condition(s): Multiple Sclerosis

Intervention(s): Sativex®, Placebo

Status: COMPLETED

Enrollment (expected or actual): 45

Allocation: RANDOMIZED

Sponsor: Almirall, S.A.

Principal Investigator:

Completion Date (primary or actual): 2013-11

CT.gov Identifier: NCT01538225

A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

First Posted: 2009-09-11

Condition(s): Parkinson's Disease

Intervention(s): IPX066, IR CD-LD

Status: COMPLETED

Enrollment (expected or actual): 471

Allocation: RANDOMIZED

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): 2011-03

CT.gov Identifier: NCT00974974

RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders

The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.

First Posted: 2023-01-30

Condition(s): Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder

Intervention(s): Avatar Intervention, Addiction supportive intervention

Status: RECRUITING

Enrollment (expected or actual): 150

Allocation: RANDOMIZED

Sponsor: Ciusss de L'Est de l'Île de Montréal

Principal Investigator:

Completion Date (primary or actual): 2028-01

CT.gov Identifier: NCT05704582

A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation

The objective of this study is to evaluate the efficacy and safety of a Chinese herbal proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive TCM syndrome.

First Posted: 2012-09-28

Condition(s): Functional Constipation, Gastrointestinal Disorders

Intervention(s): MZRW, Senna, placebo

Status: COMPLETED

Enrollment (expected or actual): 291

Allocation: RANDOMIZED

Sponsor: Hong Kong Baptist University

Principal Investigator: ZhaoXiang Bian, Professor

Completion Date (primary or actual): 2015-08

CT.gov Identifier: NCT01695850

Dental Pain 3rd Molar Tooth Extraction GW842166

This phase IIa (proof of concept) study will be conducted as a multi-centre study within the European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled, parallel group design with a positive control arm to evaluate the analgesic efficacy of pre-emptive doses of GW842166 following dental surgery (3rd molar tooth extraction). GW842166 will be administered as a single pre-operative oral dose in male and female subjects who will be randomised to take part in one of four possible treatment regimens. Pain assessments will be undertaken over a 10 hr period. Pharmacokinetic blood samples will be collected over a 48 hr period. Safety and tolerability will be evaluated by adverse event monitoring, cardiovascular assessments (ECG and vital signs) and clinical laboratory tests (haematology, clinical chemistry and urinalysis).

First Posted: 2007-03-08

Condition(s): Pain

Intervention(s): GW842166

Status: COMPLETED

Enrollment (expected or actual): 112

Allocation: RANDOMIZED

Sponsor: GlaxoSmithKline

Principal Investigator:

Completion Date (primary or actual):

CT.gov Identifier: NCT00444769

University of Alabama at Birmingham (UAB) Pediatric CBD Program

The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating debilitating, drug-resistant epilepsy.

First Posted: 2016-03-01

Condition(s): Epilepsy, Seizures

Intervention(s): Epidiolex

Status: COMPLETED

Enrollment (expected or actual): 89

Allocation: NA

Sponsor: University of Alabama at Birmingham

Principal Investigator: Martina Bebin, Professor

Completion Date (primary or actual): 2019-02-27

CT.gov Identifier: NCT02695537

EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

The main objective of the study is to evaluate the size of the common bile duct (CBD) in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.

First Posted: 2018-04-11

Condition(s): Pancreatic Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampulla of Vater Cancer, Jaundice, Obstructive

Intervention(s): Endoscopic ultrasound

Status: COMPLETED

Enrollment (expected or actual): 539

Allocation:

Sponsor: Clinical Hospital Colentina

Principal Investigator: Mihai Rimbas, Assistant Professor

Completion Date (primary or actual): 2020-04-15

CT.gov Identifier: NCT03494023

Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects

The aim of this study will be to evaluate, clinically, and radiographically the effect of Nigella Sativa oil extract Mixed with xenograft versus xenograft alone in the treatment of intra-bony defects in patients with aggressive periodontitis.

First Posted: 2021-01-25

Condition(s): Localized Aggressive Periodontitis

Intervention(s): periodontal regenerative surgery

Status: UNKNOWN

Enrollment (expected or actual): 10

Allocation: RANDOMIZED

Sponsor: Tanta University

Principal Investigator: Doaa Ahmed Yousef, lecturer

Completion Date (primary or actual): 2021-12-01

CT.gov Identifier: NCT04722380

Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.

First Posted: 2022-09-06

Condition(s): Pregnancy, Cannabis

Intervention(s): LPA + Fitbit Intervention

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: NA

Sponsor: Butler Hospital

Principal Investigator:

Completion Date (primary or actual): 2024-10-15

CT.gov Identifier: NCT05528380

Novel Approaches to Assessing Cannabis Impaired Driving (NAACID)

Researchers at the University of Colorado Anschutz Medical Campus, Colorado School of Public Health, and Injury \& Violence Prevention Center want to learn more about how people are affected by cannabis in different ways. The study will use a driving simulator to compare the driving performance of adults who use cannabis daily, occasionally or have not recently used cannabis.

First Posted: 2024-02-12

Condition(s): Cannabis Use

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 207

Allocation:

Sponsor: Colorado School of Public Health

Principal Investigator: Ashley Brooks-Russell, Associate Professor, Director (Injury and Violence Prevention Center)

Completion Date (primary or actual): 2024-09-14

CT.gov Identifier: NCT06255054

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

First Posted: 2014-02-24

Condition(s): Post-Traumatic Stress Disorder

Intervention(s): Dronabinol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 86

Allocation: RANDOMIZED

Sponsor: Wayne State University

Principal Investigator: Christine Rabinak, PhD, Assistant Professor

Completion Date (primary or actual): 2019-12

CT.gov Identifier: NCT02069366

Dronabinol in Total Knee Arthroplasty (TKA)

The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthroplasty. The main question it aims to answer are: 1. Does perioperative dronabinol use (starting in the immediate preoperative period (enrollment before 1 PM), with BID dosing concluding the evening of POD2) affect postoperative opioid consumption 24-48 hours following total knee arthroplasty? 2. Is there an effect of perioperative dronabinol use in the total knee arthroplasty patient on POD2 pain scores with ambulation? 3. Will hospital length of stay following total knee arthroplasty be affected in patients who use perioperative dronabinol as compared to control? 4. Does the use of perioperative dronabinol affect time to reach physical therapy discharge goals in postoperative total knee arthroplasty patients? 5. Is there a change in number of postoperative oxygen desaturation events in patients following total knee arthroplasty based on perioperative dronabinol use? Participants will: * Be randomized to take the dronabinol or placebo medication in 5 dosage * Answer survey questions in regard to pain, postop nausea/vomiting, cognitive/adverse event, and outcome quality and support of decision making. * Be connected to a Masimo to record oxygen saturation and an Actigraph to record sleep quality. Researchers will compare two groups: 1) intervention group and 2) control group to see if dronabinol affects postoperative opioid consumption 24-48 hours following their total knee arthroplasty surgery.

First Posted: 2021-02-02

Condition(s): Total Knee Arthroplasty, Opioid Use

Intervention(s): Dronabinol 5mg Cap, Placebo oral tablet

Status: COMPLETED

Enrollment (expected or actual): 114

Allocation: RANDOMIZED

Sponsor: Hospital for Special Surgery, New York

Principal Investigator:

Completion Date (primary or actual): 2024-04-01

CT.gov Identifier: NCT04734080

Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome

This study focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Most individuals with FXS have moderate to severe intellectual disability (ID), and caregivers are mainly concerned about aggressive behavior and anxiety problems. Since FXS individuals have a normal lifespan, the overall lifetime cost for the Canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all FXS cases. There is no cure for FXS, as all clinical trials so far have been unsuccessful.FXS is caused by transcriptional silencing of the Fragile X mental retardation protein (FMR1) gene, making FXS a simple model to study ASD and ID pathophysiological mechanisms. Of those, neuronal hyperexcitability is largely recognized as a core deficit in FXS, and a critical therapeutic target for the disorder. Using transcranial magnetic stimulation (TMS) in FXS patients, our team provided the first direct evidence of Gamma-aminobutyric acid (GABA) receptor a (GABAa) dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability (PMID: 31748507). Concurrent lines of evidence suggest that stimulation of the endocannabinoid (eCB) system with the administration of Cannabidiol (CBD) could upregulate GABAergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. CBD has been shown to increase GABA concentration levels in the brains of healthy individuals, an effect that could help correct the hyperexcitability typically found in FXS. Thus, this trial aims to define the therapeutic potential of the eCB system for FXS, by measuring the impacts of oral CBD administration on the principal inhibitory neurotransmitter system of FXS patients, and the severity of the clinical phenotype.

First Posted: 2024-02-15

Condition(s): Fragile X Syndrome

Intervention(s): CBD Oral Solution, Placebo

Status: RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Université de Sherbrooke

Principal Investigator: Francois Corbin, Full professor, Department of biochemistry

Completion Date (primary or actual): 2028-12-01

CT.gov Identifier: NCT06261502

Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

First Posted: 2006-06-09

Condition(s): Advanced Parkinson's Disease

Intervention(s): Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube, J-tube

Status: COMPLETED

Enrollment (expected or actual): 354

Allocation: NA

Sponsor: AbbVie (prior sponsor, Abbott)

Principal Investigator:

Completion Date (primary or actual): 2012-06

CT.gov Identifier: NCT00335153

Effects of Pregnancy-associated Hormones on THC Metabolism in Women

Cannabis use is prevalent among pregnant women, but the effects of use on both the developing fetus and pregnant woman are unknown. Importantly, drug exposure could be influenced by the impact of pregnancy-associated hormones on the metabolism of tetrahydrocannabinol (THC), the main psychoactive component of cannabis. The goal of this study is to determine whether cortisol and estradiol - hormones that rise dramatically during pregnancy - increase the clearance of dronabinol (THC) in reproductive age women to simulate the pregnant state. The collected data will then be used to predict the time course and magnitude of changes in THC metabolism in pregnant women, particularly with gradually increasing estradiol and cortisol concentrations that evolve over the course of pregnancy. The overall objective of this study is to better understand the effects of THC use during pregnancy on the health of the pregnant woman and developing fetus.

First Posted: 2020-05-05

Condition(s): Pregnancy Related, Cannabis Use

Intervention(s): Dronabinol

Status: COMPLETED

Enrollment (expected or actual): 14

Allocation: NON_RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Nina Isoherranen, Professor, School of Pharmacy

Completion Date (primary or actual): 2026-02-28

CT.gov Identifier: NCT04374773

Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension

Despite of the development of new anti hypertensive agents, hypertension in elderly is still a big health problem. Nigella sativa seed extract, derived from a small plant originating in Middle east which can be found abundantly in Asia, has shown small antihypertensive effect in adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the effect but as it also shows anti-inflammatory and vasodilatory activity which are important contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it has a superior potential benefit for this population. We will conduct a randomized, double blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in elderly patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract twice daily will have anti-hypertensive effect in the blood pressure of elderly with hypertension.

First Posted: 2011-07-13

Condition(s): Hypertension

Intervention(s): Nigella sativa

Status: UNKNOWN

Enrollment (expected or actual): 76

Allocation: RANDOMIZED

Sponsor: Universitas Indonesia

Principal Investigator:

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT01393054

A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.

First Posted: 2008-05-16

Condition(s): Detrusor Overactivity, Multiple Sclerosis

Intervention(s): Sativex®, Placebo

Status: COMPLETED

Enrollment (expected or actual): 135

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2005-10

CT.gov Identifier: NCT00678795

Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness

Cannabis use can lead to addiction in about 5 to 10 % of users in France. Currently, behavioral interventions are the most dependable but effectiveness is still reduced. Mindfulness meditation has demonstrated an effectiveness in several meta analysis (anxiety and depressive disorder) and seems to be relevant to reduce anxious and impulsive symptoms found in cannabis use disorders. This study proposes to determinate the mindfulness effectiveness in reduction of cannabis use in regular consumer. The consumption decrease is estimated with a retrospective diary, TLFB (Timeline Follow Back) which collect cannabis use every week until the 12th. Urine (week 0/baseline, 2, 4, 6, 8, 10, 12) and hair (week 0/baseline, 10) analyses are regularly effected. Patients included in control group get classic cares in an addictology center in CHRU of Nancy. Patients included in mindfulness group receive one session a week during eight weeks (MBRP protocol : Mindfulness -Based Relapse Prevention). The study process goes on for 12 weeks. An ancillary study measures the impact of cannabis decreases on retinal electrophysiological and architectural markers, usually disturbed by cannabis uses.

First Posted: 2017-12-08

Condition(s): Addiction, Cannabis Use, Cannabis Dependence

Intervention(s): Mindfulness based relapse prevention (MBRP), classic therapy

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Central Hospital, Nancy, France

Principal Investigator:

Completion Date (primary or actual): 2020-02-27

CT.gov Identifier: NCT03366909

Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis

Background: \- Little research has been done on how different components of cannabis (marijuana) appear in oral fluid (i.e., saliva) after smoking. Cannabinoids have been well studied in whole blood, plasma, and urine after cannabis use, but less is known about how cannabinoids appear in oral fluid after controlled drug administration and how long these biomarkers last after use. In addition, the issue of stability of cannabinoids and their glucuronide metabolites is a controversial topic that is poorly understood. These data are critical to the interpretation of cannabinoid test results. Objectives: * To collect whole blood, plasma, urine, and oral fluid specimens after smoking cannabis, to characterize the disposition and pharmacokinetics of cannabinoids in multiple biological matrices and to provide scientifically reliable data on the stability of cannabinoids and metabolites. * To test basic brain function and thinking processes after smoking cannabis. Eligibility: \- Healthy volunteers between 18 and 45 years of age who use cannabis (an average of at least twice per month in the 3 months before the study.) Design: * Participants may complete the single study session as outpatients, or they may spend the night prior to and/or following drug administration at the residential research unit in Baltimore, MD. Participants must provide a negative urine drug screen if they have not spent the evening prior to testing at the research unit. * Participants will provide whole blood, plasma, oral fluid, and urine samples, and will complete several tests of thinking and brain function at the start of the study. * Participants will smoke one standardized cannabis cigarette. Blood and oral fluid samples will be collected, and participants will repeat the tests of thinking and brain function multiple times after smoking. * Six hours after smoking the cigarette, participants must pass a neuromotor exam (testing balance and coordination) before they can be discharged from the study. Participants may be asked to stay overnight at the clinical center if there are concerns for their safety because of intoxication.

First Posted: 2010-02-19

Condition(s): Cannabis Use, Drug Abuse

Intervention(s): Cannabis Cigarette

Status: COMPLETED

Enrollment (expected or actual): 45

Allocation: NON_RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2013-11-29

CT.gov Identifier: NCT01071616

Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial

The goal of this pilot study is to test novel, adjunctive pharmacotherapy for patients with opioid use disorder (POUD) who may be at risk for overdose and other poor opioid use disorder (OUD) outcomes even after initiating buprenorphine. The investigator team proposes to test the effectiveness of combined dronabinol (synthetic delta-9-tetrahydrocannabinol \[THC\]) and Epidiolex (cannabidiol \[CBD\]) - two FDA-approved cannabinoids - to improve retention in buprenorphine treatment and reduce opioid use among POUD who are early in treatment. POUD who are early in treatment are at a critical juncture-a moment of opportunity and motivation, but also of high risk of return to opioid use and loss to follow up.

First Posted: 2025-08-29

Condition(s): Opioid Use Disorder

Intervention(s): Dronabinol Capsules, Epidiolex 100 mg/mL Oral Solution, Placebo Dronabinol, Placebo Epidiolex

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Montefiore Medical Center

Principal Investigator:

Completion Date (primary or actual): 2028-05

CT.gov Identifier: NCT07148206

Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease

Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).

First Posted: 2024-05-29

Condition(s): Parkinson Disease, Effect of Drug

Intervention(s): Opicapone 50 mg, Duodopa

Status: COMPLETED

Enrollment (expected or actual): 22

Allocation: RANDOMIZED

Sponsor: University Hospital of Ferrara

Principal Investigator:

Completion Date (primary or actual): 2024-04-25

CT.gov Identifier: NCT06432309

Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health

With perinatal cannabis use rising in Canada, robust data on short-term and long-term effects on newborns are urgently needed. However, past barriers to obtain robust data included limited sample sizes, low self-reporting and no account of postpartum exposures. Therefore, this study will be conducted as a feasibility pilot study to tease out limitations that were present in previous studies. This study will help us dictate how to conduct a larger prospective cohort study to answer any knowledge gaps currently in the field of perinatal cannabis use.

First Posted: 2022-04-04

Condition(s): Cannabis Use, Marijuana Use

Intervention(s): Cannabis use in pregnancy or cannabis exposure in utero

Status: COMPLETED

Enrollment (expected or actual): 43

Allocation:

Sponsor: Ottawa Hospital Research Institute

Principal Investigator:

Completion Date (primary or actual): 2025-02-01

CT.gov Identifier: NCT05309226

Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.

First Posted: 2021-03-16

Condition(s): Impairment, Cannabis Intoxication

Intervention(s): EyeBOX

Status: COMPLETED

Enrollment (expected or actual): 225

Allocation:

Sponsor: Oculogica, Inc.

Principal Investigator:

Completion Date (primary or actual): 2021-09-07

CT.gov Identifier: NCT04799093

Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide

To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics

First Posted: 2012-02-15

Condition(s): Parkinson Disease

Intervention(s): BIA 9-1067, Placebo, levodopa/carbidopa, levodopa/benserazide

Status: COMPLETED

Enrollment (expected or actual): 52

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2010-03

CT.gov Identifier: NCT01533116

Curcumin on NFE2L2 Gene Expression, Antioxidant Capacity and Renal Function According to rs35652124 in Diabetic Nephropathy

The increase in the prevalence of diabetes mellitus (DM) is one of the greatest public health challenges worldwide. Epidemiological studies have shown that DM is the leading cause of chronic kidney disease (CKD) in patients initiating renal replacement therapy. In our country, diabetes accounts for about 60% of all incidents of dialysis. On the other hand, CKD is currently considered a noxious disease because patients not only have the likelihood of progression to end-stage renal disease (ESRD), but because these renal alterations are associated with an increased risk of cardiovascular complications and premature death for the same cause. Most studies have focused on traditional risk factors (poor diet, physical inactivity and obesity) for the development and progression of renal damage, and less information exists on non-traditional factors such as oxidative stress and mainly, the low antioxidant response that characterizes both DM and nephropathy. In addition, there is a great variation in the susceptibility to and progression of kidney disease between different populations that is not explained by the presence of traditional factors and that could be triggered by genetic variations and its interaction with other components related to the environment and lifestyle. Fortunately, there is sufficient scientific evidence that early detection and modification of negative lifestyle factors can not only delay or halt the progression of the renal function decline to ESRD but can also significantly reduce the incidence of cardiovascular disease leading to premature death in most of these patients. Therefore, it is suggested that this risk may be determined by the interaction of lifestyle factors with the presence of susceptibility alleles, which may vary from one population to another. It is now known that hyperglycemia causes a state of oxidative stress and inflammation that can be counteracted by diet supplementation with some natural antioxidants such as curcumin. It has been shown that this molecule has multiple pharmacological properties: antioxidant, anti-inflammatory, cardioprotective, renoprotective, among others. In clinical trials a positive effect of curcumin has been seen in the treatment of diabetes and its complications. This has generated a relative optimism in the search for new curcumin treatment targets where oxidative stress is of great relevance, as is the case with CKD. However, there are still doubts about its efficacy as an adjuvant in the prevention of CKD. Additionally, the role played by interindividual variability in genes involved in the mechanism of action of curcumin is still incipient, more studies in this knowledge area are necessary.

First Posted: 2017-08-25

Condition(s): Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Polymorphism

Intervention(s): Curcumin/NFE2L2 A>G, Placebo/NFE2L2 A>G

Status: UNKNOWN

Enrollment (expected or actual): 176

Allocation: RANDOMIZED

Sponsor: Unidad de Investigacion Medica en Enfermedades Renales

Principal Investigator:

Completion Date (primary or actual): 2019-04-30

CT.gov Identifier: NCT03262363

Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial

Background Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory. Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD. Methods In this study, participants are adults aged 60 years or older with moderate to severe major depression. Participants undergo the "L-DOPA challenge"-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week. Before and after a participant completes the L-DOPA challenge, the study team assesses their depressive symptoms and psychomotor function. After the L-DOPA challenge, if a participant still shows signs of moderate or severe depression, they receive an antidepressant for 12 weeks. Aims The first aim of this study is to test the feasibility of the L-DOPA challenge-that is, whether most of the 50 participants recruited for this study will complete the L-DOPA challenge. For example, participants might have to withdraw if they can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's side effects, or if their depressive symptoms get significantly worse. Our hypothesis is that 80% of the participants will complete the L-DOPA challenge. The second aim of the study is to see if L-DOPA affects participants' depressive symptoms, processing speed, and working memory. Our hypothesis is that L-DOPA response, measured as an improvement in gait speed, is associated with a decrease in depressive symptoms and an increase in processing speed and working memory.

First Posted: 2024-10-03

Condition(s): Major Depressive Disorder

Intervention(s): Apo-levocarb

Status: RECRUITING

Enrollment (expected or actual): 50

Allocation: NA

Sponsor: University of British Columbia

Principal Investigator: Kevin Smith, Clinical Assistant Professor

Completion Date (primary or actual): 2026-05-30

CT.gov Identifier: NCT06626152

Detection of Cannabis Impairment With ISBRG's SpotLight-THC

Subjects will participate in a 2-visit study protocol in which they will be administered cannabis of pre-determined concentrations and asked to complete a simulated drive in a driving simulator. Subjects will be scanned on two SpotLight-THC (Alpha and Beta iterations) devices and peripheral venous whole blood will be collected from subjects for analysis on up to four occasions on each visit. The purpose of the investigation will be to determine whether the SpotLight-THC device is a reliable measure of THC impairment at the roadside, with an objective to identify a unique blood analyte architecture for THC impairment using near infrared light and machine learning.

First Posted: 2022-03-11

Condition(s): Cannabis

Intervention(s): Cannabis(THC) inhaled

Status: UNKNOWN

Enrollment (expected or actual): 75

Allocation: NON_RANDOMIZED

Sponsor: ISBRG Corp

Principal Investigator:

Completion Date (primary or actual): 2022-08

CT.gov Identifier: NCT05276232

Preoperative Toxicological Screening on Perioperative Anesthetic Management

Background: Preoperative substance use is a growing concern in patients undergoing metabolic bariatric surgery (MBS), but its impact on short-term outcomes remains debated. This study evaluated the association between preoperative toxicological screening test (TST) results and perioperative outcomes, including anesthesia requirements, postoperative recovery, complications, and one-year weight loss in patients undergoing MBS. Key Points 1. Preoperative toxicological screening identifies a significant proportion (15.1%) of patients undergoing metabolic bariatric surgery with recent substance use that may not be disclosed through self-reporting. 2. Patients with positive toxicological screening tests require significantly higher anesthesia doses, experience more severe postoperative pain, and have higher rates of complications and readmissions within 30 days. 3. While short-term weight loss outcomes at one year show modest differences between toxicological screening test-positive and negative patients, the perioperative risk profile suggests the need for tailored management strategies for patients with recent substance use.

First Posted: 2025-08-03

Condition(s): Toxicology, Bariatric Surgery Analgesia, Bariatric Surgery, Substance Use

Intervention(s): Multi-Drug One Step Screen Test Panel (Urine), Multi-Drug One Step Screen Test Panel (Urine)

Status: COMPLETED

Enrollment (expected or actual): 1260

Allocation:

Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

Principal Investigator: Mohamed Hany Ashour, Professor of General surgery

Completion Date (primary or actual): 2024-06-01

CT.gov Identifier: NCT07100314

The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

First Posted: 2021-09-20

Condition(s): Cannabis

Intervention(s): CBD 1mg/Kg, CBD 2mg/Kg, CBD 4mg/Kg, Placebo CBD

Status: COMPLETED

Enrollment (expected or actual): 21

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2023-06-01

CT.gov Identifier: NCT05049733

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. People with schizophrenia are more likely than healthy people to abuse cannabis. Cannabis use may worsen clinical outcomes in this group, making the identification of pharmacotherapy to treat cannabis dependence in those with schizophrenia important. The investigators intend to test the combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist clonidine, for cannabis dependence in subjects with schizophrenia. The combination of dronabinol and clonidine may alleviate cannabis withdrawal symptoms while allowing treatment-seeking outpatients to benefit from medical management (MM) sessions when they are trying to stop using cannabis. The investigators propose to assess the relationship of dronabinol and clonidine, when added to MM, on cannabis use patterns in cannabis-dependent patients with schizophrenia. Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and clonidine will significantly reduce cannabis use compared to those receiving placebo.

First Posted: 2012-05-15

Condition(s): Cannabis Dependence, Marijuana Dependence

Intervention(s): Dronabinol, Clonidine, Placebo

Status: TERMINATED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: Mclean Hospital

Principal Investigator: Kevin P. Hill, MD, MHS, Instructor in Psychiatry

Completion Date (primary or actual): 2017-08

CT.gov Identifier: NCT01598896

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)

In the POELH-II trial (Clinicaltrials.gov ID NCT05678218) patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma had the outcomes of their preoperative endoscopic ultrasound (EUS) registered. This EUS procedure was done systematically, targeting lymph nodes (LNs) with the aim to identify LN metastases preoperatively. The goal of this follow-up observational cohort study (POELH-III) is to assess the yield of preoperative EUS, with an improved EUS approach. The EUS protocol as used in the POELH-II trial was improved based on preliminary results of the POELH-II trial. The main questions it aims to answer is: \- The number of patients precluded from surgical work-up due to positive regional or extraregional LNs identified by EUS guided tissue acquisition

First Posted: 2025-09-09

Condition(s): Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Common Bile Duct Neoplasms, Adenocarcinoma of Biliary Tract

Intervention(s): Registration of all findings during preoperative Endoscopic Ultrasound

Status: RECRUITING

Enrollment (expected or actual): 250

Allocation:

Sponsor: Erasmus Medical Center

Principal Investigator: Lydi M.J.W. van Driel, MD, MSc, PhD, Principal Investigator

Completion Date (primary or actual): 2028-11-01

CT.gov Identifier: NCT07161869

Cannabics Capsules as Treatment to Improve Cancer Related CACS in Advanced Cancer Patients

The main purpose in the treatment of patients with advanced cancer and cancer anorexia cachexia syndrome (CACS) is to prolong life and to improve quality of life (QoL) as far as possible. QoL in patients with CACS is directly related to loss of appetite and loss of weight. Cannabis pills are given in Israel to advanced cancer patients with various symptoms in order to improve their QoL. There is data on safety/toxicity of cannabis, and these pills are given under the regulations of the Israel Ministry of Health. The purpose of this study is to examine the influence of Cannabics capsules on improving loss of appetite and loss of weight.

First Posted: 2015-02-09

Condition(s): Cancer Cachexia, Atypical Anorexia Nervosa

Intervention(s): Cannabics capsules

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: NA

Sponsor: Cannabics Pharmaceuticals Inc.

Principal Investigator:

Completion Date (primary or actual): 2018-04-01

CT.gov Identifier: NCT02359123

Expanded Access to ABBV-8E12

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-8E12 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

First Posted: 2018-11-16

Condition(s): Primary Tauopathy Corticobasal Degeneration Syndrome (CBD)

Intervention(s): ABBV-8E12

Status: NO_LONGER_AVAILABLE

Enrollment (expected or actual):

Allocation:

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual):

CT.gov Identifier: NCT03744546

Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS

Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.

First Posted: 2004-03-10

Condition(s): HIV Infections

Intervention(s): dronabinol

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2005-08

CT.gov Identifier: NCT00079560

Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa

No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Cannabis products have been recently legalized in many states, and CBD in particular has been shown to reduce anxiety. Therefore, CBD may represent a promising new treatment for AN. The endocannabinoid system is involved in the regulation of functions relevant to eating disorders. Furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. Prior attempts to target the endocannabinoid system in AN have focused on CB1 receptor agonists that can increase anxiety. Moreover, CBD may be particularly beneficial in decreasing anxiety in AN via its action at serotonin receptors. Lastly, the impact of CBD on eating behavior and weight in AN must be determined. The current study seeks to explore these hypotheses using the aims in the following section.

First Posted: 2021-05-07

Condition(s): Anorexia Nervosa

Intervention(s): Cannabidiol, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: University of California, San Diego

Principal Investigator: Guido Frank, Professor

Completion Date (primary or actual): 2026-06

CT.gov Identifier: NCT04878627

Improving Pain Disability With the Use of Oral Cannabinoids

The investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. The results of this pilot study will help the study team design a larger randomized controlled trial.

First Posted: 2022-04-28

Condition(s): Chronic Pain, Opioid Use, Cannabis

Intervention(s): CBD oil ( MPL-001), CDB+THC oil (MPL-005), Placebo oil

Status: COMPLETED

Enrollment (expected or actual): 51

Allocation: RANDOMIZED

Sponsor: University Health Network, Toronto

Principal Investigator:

Completion Date (primary or actual): 2026-01-12

CT.gov Identifier: NCT05351905

Diabetic Neuropathic Pain Relief, 6 Weeks Dosage Sublingual Water-soluble CBD/PEA

The purpose of the study is to evaluate whether the DIA/NPR-6 is a better pain reliever in patients with diabetic neuropathic pain of the feet compared to placebo.

First Posted: 2023-03-13

Condition(s): Diabetic Peripheral Neuropathic Pain

Intervention(s): CBD/PEA, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 52

Allocation: RANDOMIZED

Sponsor: Pure Green Pharmaceuticals Inc.

Principal Investigator:

Completion Date (primary or actual): 2023-12-05

CT.gov Identifier: NCT05766969

Personalized Real-Time DBS and PD Mechanisms

A prospective cohort of patients scheduled to undergo deep brain stimulation (DBS) implantation surgery for the treatment of Parkinson's disease as per standard of care will be invited to participate in this study. This mechanistic study is aimed at better understanding the role of basal ganglia beta band (11-35 Hz) oscillations and resonance in the manifestation of Parkinson's disease (PD) motor signs using closed-loop electrical neurostimulation, levodopa medication, and computational modeling. The ultimate goal of this study is to inform the development of closed-loop neuromodulation technology that can be programmed and adjusted in real time based on patient-specific neural activity.

First Posted: 2023-08-28

Condition(s): Parkinson Disease

Intervention(s): Neurostimulation, Carbidopa 25/Levodopa 100Mg Tab

Status: RECRUITING

Enrollment (expected or actual): 25

Allocation: RANDOMIZED

Sponsor: David Escobar

Principal Investigator: David Escobar, Assistant Staff

Completion Date (primary or actual): 2028-06-30

CT.gov Identifier: NCT06013956

PK Study of WD-1603 in Healthy Subjects

An open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects under fed conditions. A single oral dose of (either Treatment A or B or C or D) carbidopa/levodopa extended release tablets will be administered to each subject within 5 minutes after completion of standardized vegetarian breakfast under fed condition in each period as per randomization schedule.

First Posted: 2020-10-19

Condition(s): Parkinson Disease

Intervention(s): WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS

Status: UNKNOWN

Enrollment (expected or actual): 8

Allocation: RANDOMIZED

Sponsor: Hong Kong WD Pharmaceutical Co., Limited

Principal Investigator:

Completion Date (primary or actual): 2021-03-28

CT.gov Identifier: NCT04591535

Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease

The purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients with Parkinson's Disease.

First Posted: 2015-05-22

Condition(s): Parkinson Disease, Sleep Disorders

Intervention(s): Stalevo®

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: NA

Sponsor: Asan Medical Center

Principal Investigator: Sun Ju Chung, Professor

Completion Date (primary or actual): 2017-05

CT.gov Identifier: NCT02452606

Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients

This study will test the safety and efficacy of three topical agents containing oat kernel flour to determine how well they relieve skin dryness and itching related to cancer therapies. Participants will receive a body wash, a body cream, and an anti-itch balm to use at home for 4-6 weeks.

First Posted: 2019-01-08

Condition(s): Ichthyosis, Pruritus

Intervention(s): Avena Sativa Skincare Regimen

Status: COMPLETED

Enrollment (expected or actual): 53

Allocation: NA

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Principal Investigator:

Completion Date (primary or actual): 2019-12-18

CT.gov Identifier: NCT03796052

Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer.

Investigating the potential role of a novel quadrate combination therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic acid and Cannabidiol ( selective cyp 26 inhibitor) for treating early breast cancer. Breast cancer is the main cause of mortality among women. The disease presents high recurrence mainly due to incomplete efficacy of primary treatment in killing all cancer cells. Therapy resistance remains a major problem in estrogen receptor-α (ERα)-positive breast cancer. Half of estrogen receptor-positive breast cancers contain a subpopulation of cytokeratin 5 (CK5)-expressing cells that are therapy resistant and exhibit increased cancer stem cell (CSC) properties. Here, we propose a testable hypothesis that treatment of breast cancer with tamoxifen or retinoic acid or a combination of the two, may result in induction or conversion of some ER-positive breast cancer cells to ER-negative cancer cells expressing the basal cytokeratin-5 (CK5) via stimulation of progesterone receptors effect, and production . Therefore, we raised an issue with the answer " Why Antiprogestrone such Mifepristone and cyp 26 inhibitors must be combined with Tamoxifen or its combination with retinoic acid in the era of oncology for treating early breast cancer" .In fact, limited evidence has indicated that induction of CK5+ cells in ERα+ breast cancer is a unique effect of progestin (Prg) but many studies have demonstrated that progesterone (P4) increases CK5+ breast cancer cells. In case-cohort study of 405 incident breast cancer cases, elevated circulating progesterone levels were associated with a 16% increase in the risk of breast cancer. A study demonstrated that tamoxifen induced progesterone receptors (PGR) in short term treatment. Another study showed that High progesterone receptor expression correlates to the effect of adjuvant tamoxifen in premenopausal breast cancer patients. These CK5-positive cells are therapy resistant and have increased tumor-initiating potential. Also, previous work has shown that retinoic acid, a chemical that results from the body's natural breakdown of vitamin A, should act against these CK5+ cells, but clinical trials of retinoids against breast cancer have been largely unsuccessful .Therefore we suggest that combination of retinoiac acid and tamoxifen was unsucssecful in treating breast cancer owing its ability to induce progesterone receptors and production leading to increasing numbers of CK5-positive cells which are therapy resistant . Although retinoid fenretinide reduced the accumulation of CK5+ cells during estrogen depletion. A study investigated the effects of all-trans-RA (atRA) on progesterone production in immature rat GCs cultured without gonadotropin. demonstrated that atRA enhanced progesterone production by upregulating the levels of steroidogenic acute regulatory protein (StAR) and cytochrome P450scc (Cyp11a1). Here, we suggest that tamoxifen or its combination with retinoic acid must be combined with anti-progesterone (Mifepristone) to achieve treatment with significant effect against early breast cancer. Moreover, Numerous studies have shown that CYP2D6 variant carriers (around 50% CYP2D6 variant carriers in Chinese population) will not benefit a lot from tamoxifen, and combined use of CYP2D6 inhibitors will further affect the efficacy of tamoxifen. In addition, All-trans-retinoic acid acts as an inducer of CYP26A1 expression. Which is the second expected cause of unsuccessful trial of Tamoxifen and retinoic acid in breast cancer treatment. Furthermore, The CYP26 inhibitor also induced expression of atRA-responsive genes. All-trans retinoic acid (ATRA) significantly inhibited aromatase activity in a concentration-dependent manner in microsomes isolated from JEG-3 human placental carcinoma cells. One study found that high retinol was significantly. associated with reduced breast cancer risk. Another found a significant trend of reduced retinol levels with more advanced disease stage. A study showed that intake of vitamin A and retinol could reduce breast cancer risk. Therefore we will take the benefit of cyp 26 inhibitor in this trial by combining Cannabidiol, a major phytocannabinoid, as a potent atypical inhibitor for CYP2D6.

First Posted: 2021-08-23

Condition(s): Breast Cancer Female

Intervention(s): All trans-retinoic acid, 13-Cis Retinoic Acid plus Tocopherol, Mifepristone, Cannabidiol, 9 cis retinoic acid, Tamoxifen, Standard therapy

Status: UNKNOWN

Enrollment (expected or actual): 160

Allocation: RANDOMIZED

Sponsor: Mahmoud Ramadan mohamed Elkazzaz

Principal Investigator: Mahmoud Ramadan mohamed Elkazzaz, Clinical Researcher

Completion Date (primary or actual): 2021-12

CT.gov Identifier: NCT05016349

Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons

Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI). Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm. The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .

First Posted: 2008-02-26

Condition(s): Spasticity in Spinal Cord Injured Persons

Intervention(s): nabilone then placebo, placebo then nabilone

Status: COMPLETED

Enrollment (expected or actual):

Allocation:

Sponsor: University of Manitoba

Principal Investigator:

Completion Date (primary or actual): 2007-12

CT.gov Identifier: NCT00623376

Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder

The overarching goal of this study is to characterize the acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this illness. This study is expected to contribute to a better characterization of specific effects of THC in individuals with BD compared to healthy controls (HC).

First Posted: 2017-07-02

Condition(s): Delta-9-Tetrahydroncannabinol, Bipolar Disorder, Healthy Controls

Intervention(s): 4 mg Delta-9-THC, Placebo, 2 mg Delta-9-THC

Status: TERMINATED

Enrollment (expected or actual): 2

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2017-09-29

CT.gov Identifier: NCT03206463

Cannabis (THC vs. CBD) in Multiple Sclerosis

The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS). Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks.

First Posted: 2024-02-15

Condition(s): Multiple Sclerosis

Intervention(s): THC, CBD

Status: RECRUITING

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: University of Calgary

Principal Investigator:

Completion Date (primary or actual): 2027-09-30

CT.gov Identifier: NCT06261489

Can Medical Cannabis Affect Opioid Use?

The goal of this observational study is to learn how medical cannabis (MC) affects pain and the use of opioid pain medications. Participants who have chronic pain and use prescribed opioid pain medication will opt-in to using MC or not for the 3-month study. Participants who are certified in Pennsylvania will purchase specific medical cannabis products at a reduced cost from a partnering medical cannabis dispensary monthly. All participants will complete baseline, daily, and monthly assessments to observe changes across groups.

First Posted: 2024-01-16

Condition(s): Chronic Pain, Pain

Intervention(s): Medical Cannabis

Status: COMPLETED

Enrollment (expected or actual): 110

Allocation:

Sponsor: Thomas Jefferson University

Principal Investigator:

Completion Date (primary or actual): 2025-12-02

CT.gov Identifier: NCT06206252

Cannabis Impairment Detection Device Study

The goal of this study is to develop a cannabis impairment detection device in adult cannabis users. The main question\[s\] it aims to answer are: * Is the investigational device accurate and reliable at detecting cannabis impairment? * is the device safe for the collection of eye movement data from cannabis intoxicated individuals? Participants will be administered a series of Drug Recognition Expert Ocular Tests via the Gaize headset following cannabis consumption.

First Posted: 2025-08-14

Condition(s): Cannabis Intoxication

Intervention(s): Cannabis Impairment Test

Status: COMPLETED

Enrollment (expected or actual): 362

Allocation: NA

Sponsor: Gaize

Principal Investigator:

Completion Date (primary or actual): 2022-10-24

CT.gov Identifier: NCT07122349

Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy

Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal exposure to marijuana can have lasting negative effects. However, current answers to this problem are failing to reach most women who use marijuana while pregnant. This project will develop and begin testing two technology-based, highly practical interventions that could reduce the number of children who are prenatally exposed to marijuana.

First Posted: 2014-07-16

Condition(s): Marijuana Use, Pregnancy

Intervention(s): eSBIRT, Tailored texting

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Wayne State University

Principal Investigator: Steven J. Ondersma, Professor

Completion Date (primary or actual): 2017-10-27

CT.gov Identifier: NCT02191605

Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders.

Self-injuries includes repetitive actions directed at oneself, such as biting, hitting, hitting one's head or limbs, slapping oneself, pulling one's hair, or hitting oneself in the eyes, which can lead to severe injury. They are commonly reported in many neurodevelopmental disorders associated with intellectual development disorders. Faced with the difficulty of treating these self-mutilations, it seems essential to be able to explore new therapeutic avenues. Today, in the rare disease reference centers of the Necker-Enfants malades hospital, neuropathic pain in children, especially those suffering from genetic diseases with skin expression such as primary erythermalgia, is successfully and safely treated with cannabidiol in the event of failure of conventional therapies. It seems essential to be able to confirm the effectiveness of cannabidiol in treating self-injuries in children with neurodevelopmental disorders, and to help understand the mechanisms of action that underlie it. We hypothesize that the nociceptive system is involved in the occurrence of self-injuries and as a target of action of cannabidiol to treat it.

First Posted: 2026-05-04

Condition(s): Neurodevelopmental Disorders With Severe Self-injuries

Intervention(s): Cannabidiol

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 21

Allocation: NA

Sponsor: Assistance Publique - Hôpitaux de Paris

Principal Investigator:

Completion Date (primary or actual): 2030-02

CT.gov Identifier: NCT07564245

Sativex Thorough QT/QTc Study

This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic dose (24 or 36 sprays per day), and to evaluate its safety and tolerability.

First Posted: 2011-03-24

Condition(s): Effects of Sativex on ECG

Intervention(s): Placebo spray and oral moxifloxacin placebo, Sativex spray and oral moxifloxacin placebo, Sativex spray and oral moxifloxacin placebo, Placebo spray and moxifloxacin

Status: COMPLETED

Enrollment (expected or actual): 258

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2008-06

CT.gov Identifier: NCT01322139

Oral Endocannabinoids in People With Prediabetes and Diabetes

This study evaluates the relationship of endocannabinoids in saliva with inflammation and oral dysbacteriosis present in people with periodontal disease and prediabetes/type 2 diabetes

First Posted: 2023-09-15

Condition(s): PreDiabetes, Diabetes Mellitus, Type 2, Obesity, Oral Dysbiosis, Mouth Disease

Intervention(s): Observational study

Status: UNKNOWN

Enrollment (expected or actual): 60

Allocation:

Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT06040164

A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder

This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.

First Posted: 2022-06-09

Condition(s): Autistic Disorder

Intervention(s): Medical Grade Cannabis oil, Placebos

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: TO Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2022-09-01

CT.gov Identifier: NCT05413187

Neural and Psychiatric Consequences of Cannabis Use in Adolescents

The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.

First Posted: 2025-04-23

Condition(s): Cannabis Use, Depression

Intervention(s): Neuroimaging Investigation

Status: RECRUITING

Enrollment (expected or actual): 280

Allocation: NA

Sponsor: University of Miami

Principal Investigator: Vilma Gabbay, Professor

Completion Date (primary or actual): 2029-06-01

CT.gov Identifier: NCT06941298

Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy

The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional one-stent strategy. Current European Society of Cardiology (ESC) guidelines advise a provisional approach with optional stepwise two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and stepwise) caries technical difficulties and is associated with increased procedure duration and costs and higher exposure of the patient to radiation and contrast. Therefore there is upcoming interest in the use of a drug-eluting balloon (DEB) in the side branch of bifurcation lesions after provisional approach. Drug-eluting balloons are conventional semi-compliant angioplasty balloons covered with an anti-proliferating drug, which is released into the vessel wall during inflation. Several small pilot studies have successfully investigated a hybrid approach with use of DEB in addition to the provisional strategy. This hybrid approach has shown to be safe and feasible, however no large trials have been performed comparing this with current two-stent bifurcation strategies. The aim of this randomized controlled, single blinded, multicenter trial is to investigate whether a hybrid DEB approach is non-inferior to a stepwise provisional two-stent strategy in patients with de novo bifurcation lesions and a suboptimal result of the SB after provisional approach. Patients included in this study will receive PCI using provisional approach (implantation of drug-eluting stent (DES) in the main branch). Patients with an unsatisfactory result of the SB after provisional PCI (≥ 70% residual stenosis and/or diminished flow \< Thrombolysis in Myocardial Infarction (TIMI) III) will be randomized in a 1:1 ratio to receive the Hybrid DEB approach or the two-stent strategy. Patients with a satisfactory result of the side branch after provisional PCI will be included in a registry. Follow-up will be performed at 12 months and at the anticipated median 2 year follow-up with a minimum follow-up of 1 year in each subject by either a phone call or outpatient clinic visit. During follow-up information regarding cardiovascular drug use, hospitalizations, invasive and non-invasive diagnostic tests, angina status and SAE's is obtained.

First Posted: 2023-02-16

Condition(s): Coronary Artery Disease, Coronary Bifurcation Lesion

Intervention(s): Hybrid DEB approach with drug-eluting balloon, Two-stent strategy

Status: RECRUITING

Enrollment (expected or actual): 500

Allocation: RANDOMIZED

Sponsor: Cathreine BV

Principal Investigator: Koen Teeuwen, Koen Teeuwen, MD, PhD, Principal Investigator

Completion Date (primary or actual): 2030-03

CT.gov Identifier: NCT05731687

A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients

Glioblastoma (GBM) is the most common malignant brain tumor among adults. As the diagnosis is generally considered terminal, patients with GBM often suffer from anxiety and other comorbid conditions, including depression, pain, and sleep disturbance, all of which significantly impact their quality of life. Previous studies have demonstrated the potential of cannabinoids, particularly cannabidiol (CBD), to improve the aforementioned symptoms without conferring significant risks or side effects. Further, recent in-vitro and in-vivo work suggests potential cytotoxic and anti-tumor effects of CBD and other cannabinoids. This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product on measures of anxiety, pain, and quality of life in newly-diagnosed GBM patients undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor progression will also be assessed. The proposed clinical trial will provide important information that does not currently exist regarding the potential efficacy of a novel full-spectrum, ultra-high CBD product to address clinical symptoms in patients with GBM.

First Posted: 2023-03-03

Condition(s): Glioblastoma

Intervention(s): Cannabidiol (CBD), Placebo

Status: TERMINATED

Enrollment (expected or actual): 2

Allocation: RANDOMIZED

Sponsor: Mclean Hospital

Principal Investigator: Staci Gruber, Ph.D., Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core

Completion Date (primary or actual): 2025-02-11

CT.gov Identifier: NCT05753007

Risk Perception in Drug-Dependent Adults With and Without Schizophrenia

Background: * Several studies of risk perception have demonstrated a common bias known as unrealistic optimism, in which individuals feel they are less likely than other people to experience unpleasant or harmful events in their lives, but more likely to experience pleasant or beneficial events. * Previous research has indicated that individuals with schizophrenia have less of a sense of unrealistic optimism about adverse events than individuals without schizophrenia. However, research on risk perception in schizophrenia is sparse, primarily reporting on behaviors and decisions in the laboratory that likely are influenced by risk perception. * Risk perception among substance users may be viewed in two separate categories: perception of vulnerability to adverse events and perception of vulnerability to negative outcomes associated with substance use. Research in both areas has yielded mixed results. Researchers are interested in studying the connections among schizophrenia, addiction, and risk perception in order to develop better drug use prevention and treatment programs for people with and without schizophrenia. Objectives: \- To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior. Eligibility: * Individuals between 18 and 64 years of age who fall into one of the following study categories: * diagnoses of both drug dependence (marijuana or cocaine) and schizophrenia/schizoaffective disorder * diagnosis of drug dependence only (marijuana or cocaine) * diagnosis of schizophrenia/schizoaffective disorder only * healthy volunteers with no history of drug use or serious mental disorder Design: * The study will require a single visit to the research center for a 5- to 6-hour session. * Participants will complete questionnaires on medical and behavioral history, complete tests of thinking skills like memory and attention, complete a brief computerized decision-making task, and answer questions about risk perception. * Participants will also provide urine samples and breath carbon monoxide measurements to test for recent use of tobacco and other substances.

First Posted: 2009-12-14

Condition(s): Cocaine Dependence, Cannabis Dependence, Schizophrenia

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 120

Allocation:

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2012-05-03

CT.gov Identifier: NCT01031563

Teen Marijuana Check-Up

This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions. HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI) condition will reduce their use of marijuana more than participants in the computer based (Comp) condition and report fewer negative consequences. These differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI condition and will partially mediate the effect on marijuana related outcome indices. (3) The MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.

First Posted: 2010-04-23

Condition(s): Cannabis Use Disorder

Intervention(s): Marijuana Check-Ins

Status: COMPLETED

Enrollment (expected or actual): 252

Allocation: RANDOMIZED

Sponsor: Denise Walker

Principal Investigator: Denise Walker, Principal Investigator

Completion Date (primary or actual): 2014-09

CT.gov Identifier: NCT01109563

Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache

The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.

First Posted: 2005-07-22

Condition(s): Migraine With Aura, Migraine Without Aura

Intervention(s): Dronabinol MDI

Status: COMPLETED

Enrollment (expected or actual):

Allocation: RANDOMIZED

Sponsor: Solvay Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2007-03

CT.gov Identifier: NCT00123201

Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers

The aim of the planned research is to assess the dynamics of changes in the elements of the gut-brain axis (GBA), the cytokine profile and the endocannabinoid system markers, after dietary supplementation with probiotics Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 by professional dancers. Although in recent years there has been growing interest in the influence of the gut microbiota on the body's adaptation to stress stimuli and on overall health, there is a lack of information on the influence of probiotics on systems involved in maintaining neuropsychiatric balance, such as the endocannabinoid system. In order to determine the validity of the applied therapy with selective probiotics, the following will be assessed: intestinal bacteria and bacterial metabolites in the stool, cannabinoids and cannabinoid receptors and enzymes in the blood, indicators of mental distress in the blood, cytokines responsible for the modulation of the gut-brain axis in the blood, as well as questionnaires regarding the functioning of the digestive tract, fatigue, stress and sleep quality. The study will involve active dancers of the Polish Theater in Poznan, the Polish Dance Theater, the Private School of Dance Art in Poznan and students of the Academy of Physical Education in the field of Dance. Dancers are a group of athletes that is exposed to particular injuries and work-overload. Professional dancers spend multiple hours a week on intensive physical training. The largest percentage of injuries occurring in the group of professional dancers are chronic injuries, including: inflammation of soft tissues, muscle strains and tears. Professional dance is one of the most physically demanding forms of physical activity, and at the same time it is associated with a high burden on the nervous system problems caused by performances in front of an audience or subjective jury, frequent traveling and disturbances in the circadian rhythm.

First Posted: 2022-10-05

Condition(s): Fatigue, Stress, Job

Intervention(s): Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress), Starch (placebo)

Status: COMPLETED

Enrollment (expected or actual): 26

Allocation: RANDOMIZED

Sponsor: Poznan University of Physical Education

Principal Investigator: Jakub Wiącek, Principal Investigator

Completion Date (primary or actual): 2023-06-13

CT.gov Identifier: NCT05567653

Outcomes Mandate National Integration With Cannabis as Medicine

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

First Posted: 2019-05-09

Condition(s): Chronic Pain, Chronic Pain Syndrome, Chronic Pain Due to Injury, Chronic Pain Due to Trauma, Fibromyalgia, Seizures, Hepatitis C, Cancer, Crohn Disease, HIV/AIDS, Multiple Sclerosis, Traumatic Brain Injury, Sickle Cell Disease, Post Traumatic Stress Disorder, Tourette Syndrome, Ulcerative Colitis, Glaucoma, Epilepsy, Inflammatory Bowel Diseases, Parkinson Disease, Amyotrophic Lateral Sclerosis, Chronic Traumatic Encephalopathy, Anxiety, Depression, Insomnia, Autism, Opioid-use Disorder, Bipolar Disorder, Covid19, SARS-CoV Infection, COVID-19, Corona Virus Infection, Coronavirus

Intervention(s): Cannabis, Medical, RYAH-Medtech Inhaler

Status: UNKNOWN

Enrollment (expected or actual): 200000

Allocation: NON_RANDOMIZED

Sponsor: OMNI Medical Services, LLC

Principal Investigator:

Completion Date (primary or actual): 2025-12-31

CT.gov Identifier: NCT03944447

Efficacy of Inhaled Cannabis for Acute Migraine Treatment

This crossover study will evaluate 3 different treatments of vaporized cannabis (THC, THC/CBD mix, and CBD) and vaporized placebo cannabis for the acute treatment of migraine.

First Posted: 2020-04-24

Condition(s): Migraine, Cannabis, THC, CBD

Intervention(s): THC ~5%, CBD ~12%, THC ~5% and CBD ~12%, Sham Cannabis

Status: COMPLETED

Enrollment (expected or actual): 92

Allocation: RANDOMIZED

Sponsor: University of California, San Diego

Principal Investigator: Nathaniel Schuster, Assistant Professor

Completion Date (primary or actual): 2023-02-23

CT.gov Identifier: NCT04360044

Levodopa for Diabetic Retinopathy

The purpose of this study is to determine optimum dosing strategies of levodopa and determine the physiologic mechanisms that provide the therapeutic response to restore abnormalities in the electrical conductivity of the retina in people with diabetes and no clinically visible retinopathy.

First Posted: 2026-03-03

Condition(s): Diabetic Retinopathy

Intervention(s): Levodopa, Placebo

Status: COMPLETED

Enrollment (expected or actual): 230

Allocation: RANDOMIZED

Sponsor: Emory University

Principal Investigator: Andrew Hendrick, Associate Professor

Completion Date (primary or actual): 2025-11-17

CT.gov Identifier: NCT07444892

Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.

First Posted: 2016-11-04

Condition(s): Infantile Spasms

Intervention(s): GWP42003-P

Status: COMPLETED

Enrollment (expected or actual): 9

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2019-06-13

CT.gov Identifier: NCT02954887

The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management

The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) from Hemp Oil in patients with Chronic pain, anxiety and insomnia. It is believed that CBD will improve pain anxiety and sleep quality and reduce opioid use. The study will last a total of 4 weeks and involve onsite visits in addition to weekly pain assessments.

First Posted: 2021-01-28

Condition(s): CBD, Pain, Chronic, Anxiety, Insomnia, Opioid Use

Intervention(s): CBD

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: NON_RANDOMIZED

Sponsor: Advanced Pain and Rehab Specialists

Principal Investigator: Anuradha Anand, Medical Director/Physician

Completion Date (primary or actual): 2022-02-01

CT.gov Identifier: NCT04729244

Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

Assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis on driving performance in healthy volunteers in simulated driving in Marseille and Toulouse, and in real world driving to Bordeaux. Multicenter Study of phase 1, randomized, double-blind, cross plan, carried out in healthy male volunteers.

First Posted: 2010-05-06

Condition(s): Healthy

Intervention(s): Cannabis, tobacco

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Assistance Publique Hopitaux De Marseille

Principal Investigator:

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT01118364

CBD for Dental Pain

The purpose of this study is to evaulate CBD as a therapeutic approach for dental pain. Eligible subjects presented with emergency dental pain will be give a single dose of Epidiolex (FDA-approved CBD) or placebo and will be monitored for 3 hours for pain symptoms and psychologic effects.

First Posted: 2020-11-24

Condition(s): Odontalgia, Toothache

Intervention(s): Epidiolex 100 mg/mL Oral Solution, Placebo

Status: COMPLETED

Enrollment (expected or actual): 64

Allocation: RANDOMIZED

Sponsor: The University of Texas Health Science Center at San Antonio

Principal Investigator:

Completion Date (primary or actual): 2023-03-13

CT.gov Identifier: NCT04642404

Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV

People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH. The investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.

First Posted: 2022-01-27

Condition(s): Chronic Inflammation

Intervention(s): CBD oil

Status: COMPLETED

Enrollment (expected or actual): 4

Allocation: NA

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): 2022-12-12

CT.gov Identifier: NCT05209867

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy

The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.

First Posted: 2008-05-08

Condition(s): Palliative Care, Pain, Cancer

Intervention(s): Placebo, Sativex®, THC Alone

Status: COMPLETED

Enrollment (expected or actual): 177

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2004-03

CT.gov Identifier: NCT00674609

Assessment of Different Equations to Accurately Calculate LDL Cholesterol

Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. However, it has many well-known limitations, as being false in postprandial period. New equations have been developed recently. Our work consisted in the assessment of the accuracy of Friedewald, Sampson and Martin-Hopkins equations and evaluated the consequences in terms of misclassification. Given that European recommendations allow the realization of lipid profiles in postprandial period, we studied the accuracy of these equations in non-fasting state . Method The LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins). Results will be compared between equations and between calculated and measured concentrations determined using an ultracentrifugation method. The study is conducted out according to The Code of Ethics of the World Medical Association (Declaration of Helsinki) and obtained the agreement of the Scientific and Ethics Committee of the Hospices Civils de Lyon (LDL EQUATION CNIL 21\_488) Hypothesis To evaluate the most accurate equation in different conditions: * Fasting and non-fasting state * In subjects with normal or dyslipidemic lipid profile To evaluate the clinical impact on risk re-classification and lipid treatment goals if LDL-c is calculated using the best equation instead of the Friedewald's.

First Posted: 2022-10-28

Condition(s): Dyslipidemias, Lipid Disorder

Intervention(s): no intervention, Serum LDL cholesterol calculation

Status: UNKNOWN

Enrollment (expected or actual): 160000

Allocation:

Sponsor: Hospices Civils de Lyon

Principal Investigator:

Completion Date (primary or actual): 2025-12

CT.gov Identifier: NCT05598216

Interaction Between Cannabidiol, Meal Ingestion, and Liver Function

According to a recent consumer poll, over 20 million Americans regularly use cannabidiol (CBD). Moreover, 64 million Americans (over 25% of the population) report trying CBD at least once within the previous 2 years. Since the passing of the 2018 Agriculture Improvement Act, the use of hemp-derived products, such as CBD, is highly prevalent across North America. The acceleration of the use of CBD has outpaced our understanding of the associated potential risks and benefits, and the way it is processed within the body. In the current proposed project, investigators wish to continue our ongoing collaboration with Caliper Foods, a Colorado-based manufacturer of CBD products. The focus of this project is three-fold: (1) investigators will compare the pharmacokinetics of different formulations of ingestible CBD; (2) investigators will examine the potential two-way interaction between a meal and one formulation of ingestible CBD; and, (3) investigators will examine the influence of different formulations of CBD on markers of liver function.

First Posted: 2021-07-22

Condition(s): Metabolism, Liver Function, Pharmacokinetics

Intervention(s): Cannabidiol (CBD) powder formulation, Cannabidiol (CBD) Oil based tincture formulation, Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation, Cannabidiol (CBD) Gum Arabic, sorbitol base formulation, Cannabidiol (CBD) Isolate in water formulation, CBD matching Placebo

Status: COMPLETED

Enrollment (expected or actual): 26

Allocation: RANDOMIZED

Sponsor: Colorado State University

Principal Investigator: Christopher Bell, Associate Professor

Completion Date (primary or actual): 2021-12-09

CT.gov Identifier: NCT04971837

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease

This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants' quality of life.

First Posted: 2020-06-17

Condition(s): Alzheimer Disease, Dementia, Major Neurocognitive Disorder With Aggressive Behavior

Intervention(s): THC-free CBD Oil, Placebo

Status: RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Eastern Virginia Medical School

Principal Investigator: Hamid Okhravi, M.D., Associate Professor of Geriatrics and Director of Memory Clinic

Completion Date (primary or actual): 2024-03

CT.gov Identifier: NCT04436081

Role of Pentoxifylline and Celecoxib in Parkinsonism

Parkinson's disease (PD) is a chronic neurodegenerative disease clinically characterized by bradykinesia, hypokinesia, rigidity, resting tremor, and postural instability. These motor manifestations are attributed to the degeneration and selective loss of dopaminergic neurons in the substantia nigra pars compacta (SNpc), leading to a dopamine (DA) deficiency in the striatum. The environmental factors are the most common risk factor for Parkinson's disease, while hereditary determinants have minor role for disease. Furthermore, the clinical diagnosis of PD rests on the identification of characteristics related to dopamine deficiency. However, nondopaminergic and nonmotor symptoms, including cognitive dysfunction and depression, which is one of the most common and persistent symptoms, are sometimes present at an earlier disease stage and, almost inevitably, emerge with the disease progression. Neuroinflammation is considered one of the most important factors contributing critically to pathophysiology of PD . Recently, high mobility group box-1 (HMGB1) protein has been encoded as a potential inflammatory biomarker in PD. HMGB1 mediates immune response mostly through endothelial cells and macrophage activation via targeting two vital cell receptors; Toll-like receptor 4 (TLR4) and advanced glycation end products (RAGE). HMGB1 leads to a sequential cascade of inflammatory response through enhanced release of tumor necrosis factor-alpha (TNF-α) and interleukins (ILs), prominently IL-1β and IL-6. HMGB1 mediated also up-regulation of nuclear factor kappa-β (NF-κB) with subsequent flared pro-inflammatory storm.

First Posted: 2023-07-27

Condition(s): Parkinson Disease

Intervention(s): carbidopa-levodopa, Pentoxifylline 400 MG, Celecoxib 200mg

Status: COMPLETED

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Mostafa Bahaa

Principal Investigator: Mostafa Bahaa, Teaching assisstant

Completion Date (primary or actual): 2024-09-20

CT.gov Identifier: NCT05962957

Cannabidiol and Cocaine Craving/Dependence

In this study, the investigators seek to evaluate the effects of cannabidiol (CBD) on cocaine craving and relapse. Cocaine addiction is characterized by compulsive substance use and repetitive urges to consume the drug even after a sustained period of abstinence. While substance use remains the most obvious direct outcome of addiction, there is a growing interest in other core symptoms of this disorder. Craving has become a subject of great interest as it is a reliable intermediate phenotype of cocaine relapse and a distressing symptom of addiction associated with suffering. Indeed, even after a period of abstinence, cocaine-dependent individuals remain vulnerable to stress and other craving-inducing stimuli, which, in turn, lead to intense physiological responses and various negative feelings such as anger and sadness. Real-time daily monitoring of craving and drug use has shown that craving predicts cocaine relapse among cocaine-dependent individuals. In sum, working toward improving the treatment of craving could not only help prevent relapse, but also reduce patient distress on emotional, cognitive, and physiological levels. In the past decades, significant scientific efforts have been deployed toward the development of innovative strategies to beat cocaine addiction, but with partial success thus far. Psychosocial approaches have been widely used to help cocaine-dependent patients achieve better outcomes after drug cessation, but literature indicates that these strategies alone are at times insufficient to induce significant behavioural changes or a reduction in rates of drug consumption. Unlike other types of addiction, such as opioid and alcohol, no pharmacological treatment has yet been found to be truly effective in relieving cocaine-cessation symptoms like craving and anxiety or to prevent relapse. CBD is a natural cannabinoid with a favourable tolerability profile and discrete neurobiological actions that are linked to neural circuits closely involved in addiction disorders. Addiction to cocaine is characterized by alternating phases of intoxication and short abstinence, followed by recurrent drug-craving episodes which result in distress and relapse. Our hypothesis is that CBD a cannabinoid known for its broad spectrum properties is an interesting pharmacological contender to decrease cocaine craving and treat cocaine addiction. Previous studies conducted in animals and humans confirm that CBD is a very safe and tolerable medication.

First Posted: 2015-09-24

Condition(s): Substance Use Disorder, Cocaine Dependence, Withdrawal From Addictive Substance; Detoxification

Intervention(s): Cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 79

Allocation: RANDOMIZED

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

Completion Date (primary or actual): 2019-08-16

CT.gov Identifier: NCT02559167

Gender-Responsive Drug Use Treatment for Juvenile Justice Girls

Girls in the juvenile justice system have unique developmental pathways to drug use and co-occurring risk (e.g., HIV/STI) behaviors that have typically not been considered or tested in order to identify evidence-based gender-specific substance use treatment approaches for this population. This study will advance scientific knowledge and clinical practice in the drug treatment and public health fields by testing the efficacy of a pre-existing, widely disseminated gender-responsive substance use treatment (VOICES) on drug use and HIV/STI risk behavior outcomes for a broad range of substance using girls and young women (ages 12-24) who are at-risk for or already involved with the justice system.

First Posted: 2014-11-18

Condition(s): Drug Use

Intervention(s): VOICES Group, Girl Health Group

Status: COMPLETED

Enrollment (expected or actual): 132

Allocation: RANDOMIZED

Sponsor: University of California, San Francisco

Principal Investigator:

Completion Date (primary or actual): 2020-09

CT.gov Identifier: NCT02293057

Methodology for Developing an Occlusal Appliance With CBD Active Carrier

Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients

First Posted: 2021-03-01

Condition(s): Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal Appliance, CBD

Intervention(s): CBD occlusal appliance, Acrylic resin occlusal appliance

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Medical University of Silesia

Principal Investigator: Aleksandra Nitecka-Buchta, dr n. med.

Completion Date (primary or actual): 2023-01-01

CT.gov Identifier: NCT04775030

Effect of a Facial Cream Containing Cannabidiol and Hemp Oil on Skin Hydration and Acne-prone Skin

This research seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD and hemp oil on facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.

First Posted: 2019-08-05

Condition(s): Cosmetic Acne

Intervention(s): Topical Moisturizer

Status: COMPLETED

Enrollment (expected or actual): 54

Allocation: NA

Sponsor: Avicanna Inc

Principal Investigator:

Completion Date (primary or actual): 2020-01-02

CT.gov Identifier: NCT04045119

Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis

A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol, a phytocannabinoid is performed. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses, because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore, cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an antipsychotic medication that is not primarily based upon an antidopaminergic but upon different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive medication in at least a subgroup of schizophrenic and schizophreniform patients and may be expected to show additional anxiolytic effects and only minor side effects. The control condition in this parallel design will be an established neuroleptic treatment with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment strategies on side effects and neuropsychological functioning.

First Posted: 2008-03-05

Condition(s): Schizophrenia

Intervention(s): Cannabidiol, Amisulpride

Status: COMPLETED

Enrollment (expected or actual): 42

Allocation: RANDOMIZED

Sponsor: University of Cologne

Principal Investigator:

Completion Date (primary or actual): 2008-03

CT.gov Identifier: NCT00628290

Cannabinoids for the Treatment of Anxiety Disorders: An 8-Week Pilot Study

This proposed study aims to evaluate the efficacy of a daily oral cannabinoid oil preparation in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. The study will also evaluate the relationship between inflammation, anxiety and cannabinoids using biological markers as well as examine the neuro-cognitive effects of cannabinoid treatment.

First Posted: 2020-09-30

Condition(s): Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia

Intervention(s): 50:2 mg(CBD:THC)/ml - Cannabinoid Oil Oral Preparation- titrated as tolerated up to a maximum 8mls twice daily (200 mg- 800 mg total dose), Placebo Oil

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: McMaster University

Principal Investigator:

Completion Date (primary or actual): 2023-06

CT.gov Identifier: NCT04569760

Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit

An open, observational health economic study to estimate marginal cost and health consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa administered continuously

First Posted: 2006-01-09

Condition(s): Parkinson Disease

Intervention(s): Levodopa (drug), intraduodenal administration

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: NON_RANDOMIZED

Sponsor: University Hospital, Akershus

Principal Investigator: Christofer Lundqvist, Principal investigator

Completion Date (primary or actual): 2009-05

CT.gov Identifier: NCT00272688

Cannabidiol and Cannabis Concentrate Users

This study is a randomized, placebo-controlled, dose-ranging trial of plant-derived cannabidiol (CBD) among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use. The main questions it aims to answer are whether CBD, relative to placebo, reduces cannabis concentrate use, the subjective effects of cannabis, or cannabis craving. Participants will take CBD (200 mg or 400 mg per day) or placebo for 4 weeks and will complete three visits during the study medication period, all conducted using a mobile laboratory.

First Posted: 2024-08-28

Condition(s): Cannabis Use Disorder

Intervention(s): Broad Spectrum Cannabidiol (bsCBD) 400 mg, Broad Spectrum Cannabidiol (bsCBD) 200 mg, Placebo

Status: RECRUITING

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2028-06-30

CT.gov Identifier: NCT06575751

Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

First Posted: 2016-03-16

Condition(s): Cannabis, Alcohol Effect, Driving Under the Influence of Alcohol and Other Drugs

Intervention(s): Active Dronabinol, Placebo, Placebo, Active Ethanol

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Professor of Psychiatry

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT02710331

Safety Evaluation of THC-Free Hemp Protein Isolate

The goal of this clinical trial is to evaluate the safety and tolerability of a THC-free hemp protein supplement in healthy adult volunteers aged 18-65 years who do not use cannabis or hemp-derived products. The main questions this study aims to answer are: Does twice-daily consumption of 20 grams of Agoge Hemp Protein Powder for 30 days result in detectable levels of THC-COOH, the primary metabolite of THC, in urine samples? Is the supplement well tolerated, and does it affect common clinical safety markers (e.g., liver and kidney function, inflammatory markers)? This is a single-arm study with no comparison group. All participants will: * Consume 20 grams of the hemp protein supplement twice daily for 30 days * Provide blood and urine samples at baseline and Day 30 * Complete weekly surveys assessing adherence, tolerability, and adverse events

First Posted: 2025-06-15

Condition(s): Tolerability of Hemp Protein

Intervention(s): Hemp protein powder

Status: COMPLETED

Enrollment (expected or actual): 32

Allocation: NA

Sponsor: National University of Natural Medicine

Principal Investigator: Brice Thompson, Clinical Investigator

Completion Date (primary or actual): 2026-04-25

CT.gov Identifier: NCT07022275

Cannabinoid Profile Investigation of Vapourized Cannabis in Patients With Osteoarthritis of the Knee

Primary Objective: \- To determine the analgesic dose-response characteristics of vapourized cannabinoids with varying degrees of delta-9-tetrahydrocannabiol (THC)/ Cannabidiol (CBD) ratios. Secondary Objectives: * To compare functional changes and patient preferences of different cannabinoid (THC, CBD) profiles in patients with OA (Osteoarthritis); * To describe the Pharmacokinetics (PK) of vapourized cannabis of differing cannabinoid profiles in patients with OA; * To explore the short term safety of vapourized cannabis with different cannabinoid profiles. * To describe the incidence and severity of psychoactive events.

First Posted: 2014-12-24

Condition(s): Osteoarthritis, Knee

Intervention(s): Cannabis, Volcano® Medic Vapourizer

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Prairie Plant Systems Inc.

Principal Investigator:

Completion Date (primary or actual): 2019-06

CT.gov Identifier: NCT02324777

An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease

The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.

First Posted: 2009-06-11

Condition(s): Parkinson's Disease

Intervention(s): AP09004, Carbidopa/Levodopa, immediate release

Status: COMPLETED

Enrollment (expected or actual): 72

Allocation: RANDOMIZED

Sponsor: Intec Pharma Ltd.

Principal Investigator:

Completion Date (primary or actual): 2012-10

CT.gov Identifier: NCT00918177

µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions

Murray-law based single-view quantitative flow ratio (µQFR) has been recommended for guiding percutaneous coronary intervention (PCI) in selective patients. However, it's reliability has not been validated in bifurcation lesions which present complex anatomy and flluid conditions before and after PCI. The goal of this study is to investigate the diagnostic performance of µQFR in side branch after single-stent treatment for bifurcation lesions in patient with obstructive coronary artery diseases.

First Posted: 2025-08-11

Condition(s): Coronary Artery Disease, Coronary Artery Disease (Left Main), Obstructive Coronary Artery Disease, Stent Implantation

Intervention(s):

Status: RECRUITING

Enrollment (expected or actual): 290

Allocation:

Sponsor: Shanghai Zhongshan Hospital

Principal Investigator: Junbo Ge, Head of Department of Cardiology

Completion Date (primary or actual): 2026-10-31

CT.gov Identifier: NCT07116083

Effect of Oryza Sativa l Extract to LPS, ZO-1, and Intestinal Microbiota in Obese Individuals

Background : Obesity prevalence rises among adults and leads to morbidity and mortality due to subsequent inflammation pathway activation. This activation is induced by higher lipid consumption which activates the Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) pathway and alters the microbiota profile. The Oryza sativa extract contains anthocyanin which possibly affects the microbiota composition and NF-kb pathway which eventually preserves the protective layer and tight junction of the epithelial cells. Therefore it is important to address the impact of this extract on these parameters. Objective : To assess the effect of Oryza sativa extract on microbiota profile (Lactobacillus, Firmicutes, Bacteroides, Bifidobacteria, and Escherichia coli), Lipopolysaccharide/ LPS, and the tight epithelial junction (Zonula Occludens-1) among obese adults. Method: A two-arm Quasi-Experimental will be conducted, followed by two repeated measurements, at the baseline and 3 weeks after intervention Hypothesis: Oryza sativa extract lowers the LPS level, Firmicutes sp, Bacteroides sp, and increases ZO1 protein, Bifidobacteria, and Lactobacillus sp.

First Posted: 2021-04-01

Condition(s): Obesity

Intervention(s): Oryza Sativa Extract, Control

Status: UNKNOWN

Enrollment (expected or actual): 42

Allocation: NON_RANDOMIZED

Sponsor: Hasanuddin University

Principal Investigator: Bumi Herman, Assistant Lecturer

Completion Date (primary or actual): 2021-06-01

CT.gov Identifier: NCT04827628

LaunchPad: Supporting Healthy Decisions and Preventing Drug Use After High School

LaunchPad is an online substance use prevention program for high school seniors. The program is designed to help seniors develop skills and make informed decisions as they transition from high school to young adulthood. The purpose of this clinical trial is to learn whether individual LaunchPad lessons improve the specific attitudes, intentions, and skills they are designed to address. For example, researchers will examine whether the stress management lesson increases students' intentions to use healthy ways of managing stress. The main question this study aims to answer is: Does each individual LaunchPad lesson improve the specific outcomes it was designed to address? Researchers will compare students who receive a particular lesson with students who do not receive that lesson to determine whether the lesson changes the intended outcome. Participants will: * Complete a brief baseline survey * Complete two introductory online lessons * Complete one or more randomly assigned LaunchPad lessons * Complete a brief follow-up survey All surveys and lessons will be completed online.

First Posted: 2026-06-18

Condition(s): Substance-related Disorders, Alcohol-Related Disorders, Tobacco Use Disorder, Marijuana Use

Intervention(s): Introduction, Norms re: Protective Behavior Strategies (PBS), Life Skills, Norms re: Bystander Intervention Strategies, Making Friends, Norms about Substance Use

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 5000

Allocation: RANDOMIZED

Sponsor: Prevention Strategies, LLC

Principal Investigator:

Completion Date (primary or actual): 2029-04-30

CT.gov Identifier: NCT07655609

Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy

Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in patients with recent onset NAION (less than 6 weeks duration). Patients and Methods: In this double-blind randomized clinical trial, 13 patients were treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity, color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks after enrollment, and evaluated.

First Posted: 2007-02-07

Condition(s): Nonarteritic Anterior Ischemic Optic Neuropathy

Intervention(s): levodopa-carbidopa

Status: COMPLETED

Enrollment (expected or actual):

Allocation: RANDOMIZED

Sponsor: Shahid Beheshti University of Medical Sciences

Principal Investigator:

Completion Date (primary or actual): 2003-04

CT.gov Identifier: NCT00432393

ETGBD in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis

Cholecystectomy is recommended for patients with both gallbladder (GB) and common bile duct (CBD) stones to prevent recurrent biliary complications, unless there are specific reasons for surgery is considered inappropriate. The aim of this study was to evaluate the role of transpapillary gallbladder stent placement in surgically unfit patients with both CBD stone and gallstone.

First Posted: 2023-07-07

Condition(s): Efficacy

Intervention(s): ERCP(Endoscopic retrograde choangiopancreatography), ETGBD(endoscopic transpapillary gallbladder drainage)

Status: COMPLETED

Enrollment (expected or actual): 302

Allocation:

Sponsor: Seoul National University Hospital

Principal Investigator: Woo Hyun Paik, Associate Professor

Completion Date (primary or actual): 2023-05-01

CT.gov Identifier: NCT05935969

Cannabidiol Treatment in Patients With Early Psychosis

Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations in cannabis extracts. CBD has been shown to produce central effects including hypnotic, anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1) Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design, subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1) followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2) under double-blind conditions. The 2 study periods will be separated by a washout of at least 2 weeks. During each period subjects will receive study medications (CBD \[total 800mg/day\] or placebo) for a period of 4 weeks.

First Posted: 2015-07-21

Condition(s): Schizophrenia, Schizoaffective Disorder

Intervention(s): Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, MD

Completion Date (primary or actual): 2018-03-09

CT.gov Identifier: NCT02504151

Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation

The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.

First Posted: 2022-05-10

Condition(s): Coronary Artery Disease

Intervention(s): Balloon dilation

Status: COMPLETED

Enrollment (expected or actual): 48

Allocation: RANDOMIZED

Sponsor: Nanjing First Hospital, Nanjing Medical University

Principal Investigator: Shaoliang Chen, MD, Vice President of Nanjing First Hospital, Director of Cardiovascular Department

Completion Date (primary or actual): 2023-12-30

CT.gov Identifier: NCT05368129

Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study

To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory) abnormalities.

First Posted: 2006-04-21

Condition(s): Cancer, Anorexia, Taste Disorders, Olfactory Disorders

Intervention(s): Marinol (Dronabinol), Placebo

Status: COMPLETED

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Alberta Health services

Principal Investigator:

Completion Date (primary or actual): 2009-11

CT.gov Identifier: NCT00316563

Brief Family-Based Cannabis Use Intervention for Youth With Early Juvenile Justice Involvement

The goal of this randomized clinical trial is to learn if a brief family-based intervention in effective in reducing cannabis use and delinquency in youth participating in juvenile diversion. The main questions it aims to answer are: Hypothesis 1: the intervention will be (a) feasible, as evidenced by enrollment rates (\> 80%), follow-up rates (\> 80%), and withdrawal rates (\< 20%); and (b) acceptable, as evidenced by \> 80% of treatment evaluation ratings in the highest two Likert rating categories and positive exit interview feedback. Hypothesis 2: those parents in the experimental condition, as compared to the active comparison psychoeducation condition, will evidence greater improvement over time in the hypothesized family-level mechanisms proposed in the intervention (i.e., parenting practices and parent well-being) as well as in youth-level outcomes, including cannabis use, recidivism, and HIV/STI risk. Researchers will compare the family-based treatment to parenting psychoeducation. Caregiver and youth participants will complete measures relevant to primary outcomes and putative mechanisms at baseline, 3-month, and 6-month follow-ups.

First Posted: 2026-07-14

Condition(s): Cannabis Use, Delinquency

Intervention(s): Brief Family Based Intervention, Parenting Psychoeducation

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Rhode Island Hospital

Principal Investigator: Kaitlin Sheerin, Research Scientist

Completion Date (primary or actual): 2029-02-28

CT.gov Identifier: NCT07700849

The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain

Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain can persist for months or even years and significantly diminishes quality of life. The exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the basis of the present research proposal. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.

First Posted: 2012-03-23

Condition(s): Postsurgical Pain, Abdominal Pain, Chronic Pain

Intervention(s): Tetrahydrocannabinol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Radboud University Medical Center

Principal Investigator:

Completion Date (primary or actual): 2014-06

CT.gov Identifier: NCT01562483

Bioavailability of Levodopa 250 mg and Carbidopa 25 mg With Regards to Reference Product

This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 tablet formulation containing Levodopa 250 mg and Carbidopa 25 mg. The study will be performed at a single site with 44 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.

First Posted: 2022-02-22

Condition(s): Bioequivalence

Intervention(s): Levodopa 250mg and Carbidopa 25mg Test Drug tablet, Levodopa 250mg and Carbidopa 25mg Referent Product tablet

Status: COMPLETED

Enrollment (expected or actual): 44

Allocation: RANDOMIZED

Sponsor: Laboratorios Andromaco S.A.

Principal Investigator:

Completion Date (primary or actual): 2022-02-17

CT.gov Identifier: NCT05250141

Mapping Brain Glutamate in Humans: Sex Differences in Cigarette Smokers

The proposed study evaluated sex differences in glutamate (Glu), with a focus on the dorsal anterior cingulate cortex (dACC), anterior insula, and thalamus, as well as how it is influenced by sex (males vs. females), smoking state (overnight abstinent vs. sated), and circulating ovarian hormones (estrogen and progesterone) in women. Glu was measured in the entire brain with special focus on the dorsal anterior cingulate cortex (dACC), anterior insula, and thalamus, all of which have been implicated in tobacco withdrawal, using an echo-planar spectroscopic imaging (EPSI) variant of magnetic resonance spectroscopy (MRS). Serum ovarian hormones (estrogen and progesterone) were measured for female participants to determine relationships between brain Glu and this hormone. Glu was be measured in smokers after overnight (\~12 h) abstinence and after participants smoked the first cigarette of the day.

First Posted: 2022-03-15

Condition(s): Sex, Cigarette Smoking

Intervention(s): Abstinence and Smoking

Status: COMPLETED

Enrollment (expected or actual): 58

Allocation:

Sponsor: University of California, Los Angeles

Principal Investigator: Edythe London, Distinguished Professor In Residence

Completion Date (primary or actual): 2023-03-31

CT.gov Identifier: NCT05279053

Cannabis Effects on Electroencephalography

Background: Tetrahydrocannabinol (THC) is a partial CB1/CB2 agonist and causes its pharmacological effects by binding to cannabinoid receptors. CB1 receptors are predominantly located in the brain (highest densities at hippocampus, cerebellum and the striatum) and at low levels in the brainstem. CB2 receptors are predominantly in the spleen and in hematopoietic cells. THC is highly lipophilic and is readily absorbed and distributed to the brain and other organs. Most of the neuropsychological studies carried out so far show that the mainly affected neurocognitive functions in cannabis users are: memory, attention, psychomotor capacity, speed of information processing and alterations of executive functions (resistance to interference, planning capacity, decision-making, verbal fluency and working memory). These effects are dose-dependent. Hypothesis: Functional CB1 receptor activation by the THC contained in the cannabis flos will induce dose-dependent effects on EEG, physiological functions and behavior: 1. EEG alterations. 2. Increase in cannabis subjective effects. 3. Increase in heart rate. 4. Increase in psychopathology scale Psychotomimetic State Inventory (PSI) score. 5. Increase in plasma cortisol concentrations. Objectives: Main pharmacodynamic objective: To assess the effects of Cannabis flos on electroencephalography (EEG) in healthy recreational cannabis users. Secondary pharmacodynamic objectives: (i) To assess the effects of Cannabis flos on: cannabis subjective effects, heart rate and psychopathology scale; (ii) To establish the pharmacokinetic/pharmacodynamic relationships between THC plasma concentrations and pharmacodynamic endpoints. Safety and tolerability objectives: To assess the safety and tolerability of THC in these subjects. Methods: Phase I, prospective, monocentric, double-blind, randomized, placebo-controlled, parallel group study to assess the THC effects on EEG neural oscillations in 16 healthy subjects with recreational cannabis use.

First Posted: 2020-03-20

Condition(s): Healthy Volunteers

Intervention(s): Cannabis Sativa, Cannabis placebo

Status: TERMINATED

Enrollment (expected or actual): 16

Allocation: RANDOMIZED

Sponsor: Parc de Salut Mar

Principal Investigator:

Completion Date (primary or actual): 2020-07-09

CT.gov Identifier: NCT04316598

Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy

The aim of the trial is to prove the efficacy and safety of VER-01 compared to placebo in patients with chronic painful lumbosacral radiculopathy (PLSR) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

First Posted: 2025-05-02

Condition(s): Lumbosacral Radiculopathy

Intervention(s): VER-01, Placebo

Status: RECRUITING

Enrollment (expected or actual): 810

Allocation: RANDOMIZED

Sponsor: Vertanical GmbH

Principal Investigator:

Completion Date (primary or actual): 2028-09

CT.gov Identifier: NCT06956014

Assessing Claims of Cannabis as an Anti-cancer Agent (CATA)

The purpose of the study is to find out how cannabis may help control cancer growth by reviewing medical records of patients who report cannabis helped treat their cancer.

First Posted: 2025-08-06

Condition(s): Cancer, Cancer (With or Without Metastasis)

Intervention(s):

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 50

Allocation:

Sponsor: HealthPartners Institute

Principal Investigator:

Completion Date (primary or actual): 2027-01

CT.gov Identifier: NCT07107607

Resistance Exercise and Cannabis Use

Cannabis is the most widely used illicit drug and rates of hazardous use, and cannabis use disorders (CUDs), have continued to rise in recent years. The highest rates of use and CUDs are seen in young adults (20 - 24 years old) with more than 50% of young adults reporting lifetime use of cannabis, 35% report use in the past year, and 20% report use in the past month. Increased exposure produces higher risk for detrimental psychological and behavioral effects of cannabis use. Given this increased prevalence of cannabis use and associated risks, identifying effective behavioral strategies that reduce cannabis craving, negative psychological effects, and alter neurobiological mechanisms underlying problematic cannabis use are an avenue of needed research. Exercise, particularly resistance exercise, is a behavioral intervention with considerable potential as an adjunctive treatment for CUD.

First Posted: 2019-03-08

Condition(s): Cannabis Use Disorder

Intervention(s): Exercise, Video Control

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Penn State University

Principal Investigator: Gwendolyn Thomas, Assistant Research Professor, Kinesiology

Completion Date (primary or actual): 2024-12-01

CT.gov Identifier: NCT03867786

The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler

Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological treatment for neuropathic pain. The objective of this study is to explore the pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler, (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg / 20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis Inhaler device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events will be monitored following the inhalation.

First Posted: 2016-04-06

Condition(s): Healthy

Intervention(s): Kite Systems cannaHALER cannabis Inhaler.

Status: UNKNOWN

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: Kite Systems

Principal Investigator:

Completion Date (primary or actual): 2017-08

CT.gov Identifier: NCT02729623

Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine

The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving methadone or buprenorphine.

First Posted: 2021-10-13

Condition(s): Addiction

Intervention(s): CBD Day 1, CBD Day 2, CBD Day 3

Status: COMPLETED

Enrollment (expected or actual): 7

Allocation: NON_RANDOMIZED

Sponsor: Yale University

Principal Investigator: Joao De Aquino, Principal Investigator

Completion Date (primary or actual): 2024-06-28

CT.gov Identifier: NCT05076370

Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing

The goal of this clinical trial is to learn how adding brain stimulation to a brief counseling session affects adults with cannabis use disorder. The counseling session uses motivational interviewing, which helps people talk through their reasons for changing or not changing cannabis use. The brain stimulation is called transcranial alternating current stimulation (tACS). tACS uses electrodes on the scalp to give a very weak electrical current for a short time. The main questions it aims to answer are: * Does active tACS affect what participants say during the counseling session? * Does active tACS change brain activity after the session? * Is active tACS related to less cannabis use during the month after the session? Researchers will compare motivational interviewing with active tACS to motivational interviewing with placebo stimulation. Placebo stimulation uses the same setup but does not provide the active 30-minute stimulation. Participants will be assigned by chance to one of these groups, and neither participants nor the study staff member running the session will know which type of stimulation is used. Participants will complete questionnaires, breath and urine tests, a recorded counseling session during active or placebo stimulation, MEG and MRI brain scans, daily text-message check-ins about cannabis use, and follow-up questionnaires about one month later.

First Posted: 2026-08-26

Condition(s): Cannabis Use Disorder

Intervention(s): transcranial alternating current stimulation, sham transcranial alternating current stimulation, Motivational interviewing (MI)

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 82

Allocation: RANDOMIZED

Sponsor: The Mind Research Network

Principal Investigator:

Completion Date (primary or actual): 2028-08

CT.gov Identifier: NCT07787572

Impact of Cannabis Consumption on Psychotic Symptoms and Reality Monitoring in Patients With Schizophrenia: a Real-life Study

This study aims to examine the dual effects of cannabis consumption on both positive and negative symptoms of schizophrenia, across laboratory and real-world contexts. By integrating ecological momentary assessment (EMA) with cognitive tasks such as reality monitoring, the research seeks to clarify how cannabis use influences symptom severity and cognitive functioning in individuals with schizophrenia. Gaining insight into these relationships may contribute to the development of more effective management strategies and ultimately improve outcomes for patients living with schizophrenia.

First Posted: 2025-12-30

Condition(s): Schizophrenia

Intervention(s): Ecological Momentary Assessment (EMA) and Reality Monitoring tasks

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 120

Allocation: NON_RANDOMIZED

Sponsor: Centre Hospitalier Charles Perrens, Bordeaux

Principal Investigator:

Completion Date (primary or actual): 2028-12-31

CT.gov Identifier: NCT07309159

A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss

Study aim to evaluate the efficacy and safety of a novel technique of UTERINE COOLING during repeated cesarean section (CS) in reducing blood loss, and record any adverse effects following it.

First Posted: 2019-01-04

Condition(s): Cesarean Section Complications, Intrapartum Hemorrhage, Postpartum Hemorrhage, Atony, Uterine

Intervention(s): Uterine Cooling Technique

Status: COMPLETED

Enrollment (expected or actual): 99

Allocation: RANDOMIZED

Sponsor: Al-Azhar University

Principal Investigator: Amro M. Hetta, Doctoral Degree (MD) Candidate

Completion Date (primary or actual): 2019-03-25

CT.gov Identifier: NCT03793153

The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis

Over the last two years, the United States has witnessed enormous change concerning the acceptance of marijuana. The number of persons with MS (PwMS) using cannabis to treat their symptoms is expected to rise, and it is important to provide clinicians and PwMS with evidence based information on the safety and effectiveness of marijuana. In addition, scientists need to identify the effects of medical marijuana as the compound action of different cannabinoids, specifically tetrahydrocannabinol (THC) and cannabidiol (CBD). The ratio of CBD to THC may have an important impact on the effects of the marijuana, which in turn may have important implications for the medical benefits. The overarching goal of this study is to advance a better understanding of the potential positive and negative effects associated with different strains of marijuana, using an interventional design. The investigators will examine three strains that differ markedly on THC potency (A. THC \<1%, CBD \> 10%; B. THC \>10%, CBD \< 1%; C. THC 510%, CBD 510%) to determine whether the level of THC is associated with differences in motor and cognitive functions in PwMS. One hundred PwMS will be recruited for this project and followed for 3 months following designation to one of three strains of marijuana with different ratios of CBD to THC or a placebo marijuana (THC 0%, CBD 0%). It is hypothesized that the strains with a high CBD to THC ratios will demonstrate the most benefits on measures of motor and cognitive function.

First Posted: 2017-06-01

Condition(s): Multiple Sclerosis

Intervention(s): Medical Marijuana, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Colorado State University

Principal Investigator: Thorsten Rudroff, Assistant Professor

Completion Date (primary or actual): 2018-01

CT.gov Identifier: NCT03172741

Nigella Sativa in COVID-19

Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.

First Posted: 2020-05-26

Condition(s): COVID-19, SARS-CoV-2

Intervention(s): Nigella sativa oil

Status: COMPLETED

Enrollment (expected or actual): 183

Allocation: RANDOMIZED

Sponsor: King Abdulaziz University

Principal Investigator: Dr Abdulrahman E. Koshak, Assistant Professor

Completion Date (primary or actual): 2020-12-31

CT.gov Identifier: NCT04401202

Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis

The purpose of the trial is to investigate the effect of specialized treatment of cannabis abuse among young people with psychosis. The specialized treatment consists of manualized individual treatment and group therapy. It will be compared with the standard treatment, which consists of non-specialized, non-manualized treatment. 140 patients will be randomised to one of the two treatments, and the investigator(s) will be blinded to the treatment received.

First Posted: 2007-06-08

Condition(s): Marijuana Abuse, Psychotic Disorders, Schizophrenia

Intervention(s): Cognitive behavioral therapy with motivational interviewing, Non-manualized standard treatment

Status: COMPLETED

Enrollment (expected or actual): 103

Allocation: RANDOMIZED

Sponsor: Bispebjerg Hospital

Principal Investigator:

Completion Date (primary or actual): 2011-01

CT.gov Identifier: NCT00484302

Effects of Cannabidiol on Marijuana-seeking in Humans

The purpose of the proposed study is to investigate the effectiveness of cannabidiol for reducing marijuana seeking in non-treatment seeking volunteers. Cannabidiol is a cannabinoid (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of marijuana. Assess the ability of acute smoked CBD pretreatment to reduce marijuana-seeking behavior and increase price-elasticity of marijuana demand.

First Posted: 2016-05-19

Condition(s): Marijuana Abuse

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation:

Sponsor: Wayne State University

Principal Investigator: Leslie Lundahl, Principal Investigator

Completion Date (primary or actual): 2019-01-31

CT.gov Identifier: NCT02777502

Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis

Psychotic disorders impact 4.6 people per 1000 globally, with approximately 1.5 million Canadians affected. The age of onset for psychotic disorders often begin during the critical years of youth and early adulthood, resulting in significant challenges for individuals and their families, including difficulties with thinking, relationships, and overall well-being. They also carry significant economic costs, both for health care and lost productivity. Early intervention services have been shown to improve outcomes when provided during the first few years of illness known as early phase psychosis (EPP). However, substance use, especially alcohol and cannabis, can interfere with the effectiveness of these services. Many young people with psychosis misuse these substances, which can harm brain development, worsen symptoms, reduce medication use, and lower quality of life. Despite understanding the risks, there are few effective ways to reduce substance misuse in patients with EPP. One promising approach to reducing substance misuse in this population is cognitive remediation therapy, which helps improve thinking skills and everyday functioning. Studies have found that some cognitive remediation therapies can help reduce alcohol use in chronic schizophrenia, but there is limited research targeting the EPP population. Our research team at the Nova Scotia Early Psychosis Program recently completed a pilot study that indicated a therapy called Cognitive Enhancement Therapy (CET) helped participants reduce their problematic alcohol and cannabis use. However, challenges with recruitment and lower attendance rates noted towards the end of the 6-month therapy course suggests that patients with EPP would benefit more from a therapy with a shorter timeframe. Alternatively, Action-Based Cognitive Remediation (ABCR) targets the same cognitive domains believed to help reduce substance use as CET, but has a shorter, more concise schedule. ABCR cover 16 sessions delivered bi-weekly for 2 months, compared to 45 sessions over 6 months of CET. ABCR has been tested in the EPP population and has shown positive results when delivered in person, hybrid and remotely. Although this therapy is demonstrating benefits for patients including improvement in daily functioning and social cognition, its effects on substance misuse have not been researched. This study aims to investigate whether treatment with ABCR helps patients with EPP reduce their alcohol and/or cannabis use.

First Posted: 2025-07-09

Condition(s): Psychosis, Alcohol Use Disorder, Cannabis Use Disorder

Intervention(s): Action-Based Cognitive Remediation

Status: RECRUITING

Enrollment (expected or actual): 50

Allocation: NON_RANDOMIZED

Sponsor: Nova Scotia Health Authority

Principal Investigator: Phil Tibbo, Principal Investigator

Completion Date (primary or actual): 2028-03-31

CT.gov Identifier: NCT07056894

A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

An open-label phase to assess the frequency and severity of adverse events in recurrent glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B). Part A will be reported here.

First Posted: 2013-03-18

Condition(s): Cancer

Intervention(s): Sativex

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2016-06

CT.gov Identifier: NCT01812603

A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.

First Posted: 2008-07-11

Condition(s): Pain, Peripheral Neuropathy

Intervention(s): Sativex®

Status: COMPLETED

Enrollment (expected or actual): 380

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2007-06

CT.gov Identifier: NCT00713323

Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia

The purpose of the study is to investigate these effects of Second-Generation Antipsychotic (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine, risperidone or ziprasidone).

First Posted: 2016-11-16

Condition(s): Schizophrenia

Intervention(s):

Status: UNKNOWN

Enrollment (expected or actual): 300

Allocation:

Sponsor: Xijing Hospital

Principal Investigator:

Completion Date (primary or actual): 2017-12

CT.gov Identifier: NCT02964923

Dronabinol Naltrexone Treatment for Opioid Dependence

The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.

First Posted: 2009-12-02

Condition(s): Opioid Dependence

Intervention(s): injectable naltrexone and dronabinol, Naltrexone and placebo

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Adam Bisaga, Research Psychiatrist

Completion Date (primary or actual): 2012-12

CT.gov Identifier: NCT01024335

Differences in Cannabis Impairment and Its Measurement Due to Route of Administration

This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.

First Posted: 2017-04-21

Condition(s): Behavioral Pharmacology of Cannabis

Intervention(s): cannabis

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2020-02-01

CT.gov Identifier: NCT03122691

Cannabis Effects on Opioid Self-Administration

The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive/desire to take opioids.

First Posted: 2026-06-25

Condition(s): Opioid Use Disorder, Cannabis Use

Intervention(s): Cannabis, Placebo Cannabis, Intranasal Opioid Agonist, Oral Opioid Agonist

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Shanna Babalonis, PhD

Principal Investigator: Shanna Babalonis, PhD, Associate Professor

Completion Date (primary or actual): 2031-07-30

CT.gov Identifier: NCT07668635

The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study

The objective of the current study is to prospectively assess the effect of cannabis on pain and functional outcomes in a large group of patients with chronic pain.

First Posted: 2015-03-13

Condition(s): Chronic Pain

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 400

Allocation:

Sponsor: Hadassah Medical Organization

Principal Investigator: Elyad Davidson, MD

Completion Date (primary or actual): 2020-11-01

CT.gov Identifier: NCT02388217

TACUNA (Traditions and Connections for Urban Native Americans)

This study responds to Request For Application-DA-19-035, HEAL (Helping End Addiction Long Term) initiative: Preventing OUD in Older Adolescents and Young Adults (ages 16-30) by developing and implementing a culturally centered intervention to address opioid use among urban AI/AN emerging adults in California. The primary goal of this study is to compare AI/AN emerging adults who receive TACUNA plus a Wellness Circle (WC) to those AI/AN emerging adults who receive an opioid education workshop on outcomes (e.g., opioid misuse and alcohol and other drug use) over a period of 12 months. TACUNA will be a motivational interviewing group intervention that incorporates traditional practices and discussion of how to cultivate healthy social networks and cultural worlds. The Wellness gathering will be for emerging adults and people in their social network, and will focus on how social networks and cultural connectedness influence healthy behaviors. Opioid education will focus on discussion of opioid misuse within the AI/AN urban community and ways to reduce use in a culturally appropriate manner. Investigators expect those who receive TACUNA + WG will report less opioid and AOD (alcohol and other drug) use frequency, fewer consequences, less time spent around peers who use opioids and AOD, and less perceived prevalence of peer use compared to opioid education over a period of 12 months. Also, investigators will evaluate the intervention's effects on secondary outcomes of social networks and cultural connectedness. Survey data is collected at baseline, 3-months, 6-months and 12-months. Longitudinal analyses will compare intervention participant and control participants on primary and secondary outcomes.

First Posted: 2020-11-05

Condition(s): Opioid Use, Alcohol Drinking, Marijuana Use

Intervention(s): TACUNA plus Wellness Circle, Opioid Education Workshop

Status: COMPLETED

Enrollment (expected or actual): 541

Allocation: RANDOMIZED

Sponsor: RAND

Principal Investigator:

Completion Date (primary or actual): 2025-07-28

CT.gov Identifier: NCT04617938

Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

First Posted: 2021-02-11

Condition(s): Parkinson's Disease (PD)

Intervention(s): ABBV-951

Status: COMPLETED

Enrollment (expected or actual): 118

Allocation: NA

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2026-04-27

CT.gov Identifier: NCT04750226

Repeated Administration of Cannabis Varying in THC and CBD

The majority of the \>3 million medical cannabis patients in the U.S. use cannabis products to manage pain but many questions remain. This project is designed to answer three questions that will fill important voids in the field's understanding of sustained cannabis use: 1) is abrupt cessation of cannabis associated with increased pain sensitivity; 2) does tolerance develop to the analgesic and abuse-related effects of repeatedly administered cannabis with varying ratios of THC and CBD, and is this tolerance reversible following a period of abstinence; 3) how does repeated cannabis use affect levels of endocannabinoids, and are these changes associated with changes in pain sensitivity and abuse liability? In this study, the investigators will enroll participants (N=100 healthy, cannabis-using men and non-pregnant women, ages 21-65) inpatient for 15 days. They will be randomized to one of four cannabis conditions (n=25/group). Following a day of standardization on which participants will receive their assigned cannabis condition (Day 1), cannabis will be administered repeatedly for 14 days (Day 2-15). The investigators will measure abuse-related effects ("Good Drug Effect"), endocannabinoid levels and two distinct types of experimental pain: The Cold Pressor Test and Quantitative Sensory Testing Thermal Temporal Summation. Given the widespread use of cannabis for pain, understanding the consequences of daily repeated administration of cannabis with THC:CBD ratios that are representative of most medical cannabis products on pain, abuse liability, and endocannabinoids is imperative.

First Posted: 2022-10-03

Condition(s): Cannabis

Intervention(s): Cannabis

Status: SUSPENDED

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Margaret Haney, Clinical professor in Psychiatry

Completion Date (primary or actual): 2034-09-30

CT.gov Identifier: NCT05563948

Age Differences in the Effects of Cannabis on Simulated Driving

Epidemiological studies suggest that the use of cannabis is associated with an increase in the risk of motor vehicle collisions. It is also known that younger users may be at increased risk for motor vehicle collisions. Further, the frequency with which cannabis is used may be an important variable in determining the effects of cannabis on driving. The purpose of the present study will be to investigate the effects of cannabis on simulated driving in young as compared to middle-aged drivers. Half of the participants will be occasional users of cannabis and half will be frequent users of cannabis.

First Posted: 2020-03-30

Condition(s): Cannabis

Intervention(s): Cannabis, Placebos

Status: RECRUITING

Enrollment (expected or actual): 128

Allocation: NON_RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2027-03

CT.gov Identifier: NCT04325958

Does OCT Optimise Results of Stenting on the Left Main Stem

The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

First Posted: 2020-05-18

Condition(s): Myocardial Infarction, Myocardial Ischemia, Non ST Segment Elevation Myocardial Infarction

Intervention(s): Use of OCT to guide the angioplasty procedure

Status: COMPLETED

Enrollment (expected or actual): 197

Allocation: RANDOMIZED

Sponsor: Centre Hospitalier Universitaire de Besancon

Principal Investigator:

Completion Date (primary or actual): 2024-05-31

CT.gov Identifier: NCT04391413

Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

First Posted: 2015-03-31

Condition(s): Cannabis, Alcohol Effect, Driving Under the Influence of Alcohol and Other Drugs

Intervention(s): Active delta-9-THC, Placebo, Active Ethanol, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Professor of Psychiatry

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT02404688

Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting

This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.

First Posted: 2023-03-16

Condition(s): Seizures

Intervention(s): Epidiolex

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 158

Allocation:

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2026-07

CT.gov Identifier: NCT05772429

The Effectiveness of a Brief Motivational Nursing Intervention

This was a two-staged study undertaken in entertainment-sector workers in Spain: the first part was transversal and observational, and the second was semi-experimental. A short group-based motivational intervention session was implemented by nursing staff, and a before and after evaluation was completed. By reducing the patients' perception of their quality of life, this brief nursing intervention facilitated a favourable increase in the motivation for change among these workers and was effective in 12% of cases.

First Posted: 2019-10-14

Condition(s): Behavior, Addictive

Intervention(s): brief motivational psychoeducational therapy

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: NA

Sponsor: Cardenal Herrera University

Principal Investigator: Isabel Almodóvar Fernández, Nursing Coordinator

Completion Date (primary or actual): 2016-10-31

CT.gov Identifier: NCT04125303

Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain

The aim of this study is to evaluate the efficacy of oral administration of nabilone or THC/CBD administration in combination with spinal cord stimulation (SCS) in FBSS patients refractory to other available therapeutic strategies.

First Posted: 2017-07-07

Condition(s): FBSS

Intervention(s): Nabilone, THC/CBD

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation:

Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Principal Investigator: Gioacchino Calapai, Full Professor of Pharmacology

Completion Date (primary or actual): 2016-01-31

CT.gov Identifier: NCT03210766

A Study Of Synthetic THC And Sleep

The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP/dronabinol.

First Posted: 2026-05-06

Condition(s): Obstructive Sleep Apnea

Intervention(s): Dronabinol, Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 72

Allocation: RANDOMIZED

Sponsor: Mayo Clinic

Principal Investigator: Virend Somers, MD, PhD, Principal Investigator

Completion Date (primary or actual): 2028-04

CT.gov Identifier: NCT07570953

The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy

Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.

First Posted: 2019-09-13

Condition(s): Diabetic Neuropathies

Intervention(s): CBD

Status: COMPLETED

Enrollment (expected or actual): 32

Allocation: NA

Sponsor: Pure Green

Principal Investigator:

Completion Date (primary or actual): 2019-12-01

CT.gov Identifier: NCT04088929

Improving Therapeutic Learning for PTSD

The proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.

First Posted: 2020-09-22

Condition(s): PTSD, Post Traumatic Stress Disorder

Intervention(s): L-DOPA, Placebo

Status: RECRUITING

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: University of Wisconsin, Madison

Principal Investigator:

Completion Date (primary or actual): 2023-12

CT.gov Identifier: NCT04558112

Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique

The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.

First Posted: 2014-09-05

Condition(s): Complications of Surgical and Medical Care: General Terms

Intervention(s): ERCP with loop tip wire, ERCP for cannulation

Status: COMPLETED

Enrollment (expected or actual): 320

Allocation: RANDOMIZED

Sponsor: Azienda Ospedaliera San Paolo

Principal Investigator: Enzo Masci, Chief of Gastrointestinal Endoscopy

Completion Date (primary or actual): 2014-08

CT.gov Identifier: NCT02232451

Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors

The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital. During a regularly scheduled psychosocial visit, participants complete the World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This short questionnaire helps identify patterns of use related to tobacco, alcohol, cannabis, prescription medications, and other substances. Survivors whose results show possible risk receive a brief, supportive counseling session during the same appointment. This session uses motivational interviewing techniques to help individuals reflect on their use and consider steps to reduce potential harm. Primary Objective: \- Assess the feasibility and acceptability of integrating a standardized substance use screening and brief intervention protocol into routine psychosocial workflows within a survivorship clinic. Secondary Objective: \- Evaluate the fidelity of delivering a brief substance use intervention to reduce substance use behaviors among survivors.

First Posted: 2026-04-07

Condition(s): Survivors of Childhood Cancer, Substance Use

Intervention(s): WHO ASSIST v3.1 Screening with Feedback, ASSIST Linked Brief Intervention (10 Step Motivational interviewing (MI)/FRAMES), WHO ASSIST v3.1 Screening (No Feedback)

Status: RECRUITING

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: St. Jude Children's Research Hospital

Principal Investigator:

Completion Date (primary or actual): 2028-10

CT.gov Identifier: NCT07516301

Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures

The primary aim of Part A of the study to assess the efficacy and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with Epilepsy with myoclonic-atonic seizures (EMAS) -associated seizures. Part B of this study will be conducted to evaluate the long-term safety and tolerability of GWP42003-P in participants with EMAS.

First Posted: 2022-03-21

Condition(s): Seizures Associated With EMAS

Intervention(s): GWP42003-P, Placebo

Status: TERMINATED

Enrollment (expected or actual): 3

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2023-09-28

CT.gov Identifier: NCT05288283

Neurexan - a Clinical Trial in Short-Term Insomnia Patients

This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing. Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires. The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms. Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia.

First Posted: 2024-02-26

Condition(s): Insomnia, Stress Reaction

Intervention(s): Neurexan, Placebo

Status: COMPLETED

Enrollment (expected or actual): 81

Allocation: RANDOMIZED

Sponsor: Biologische Heilmittel Heel GmbH

Principal Investigator:

Completion Date (primary or actual): 2026-02-16

CT.gov Identifier: NCT06278077

Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving

This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking Cannabis use disordered participants. Participants will then undergo either active, or sham rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.

First Posted: 2015-10-02

Condition(s): Cannabis

Intervention(s): Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator:

Completion Date (primary or actual): 2016-03

CT.gov Identifier: NCT02567344

CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome

This study is a preliminary open-label, single-arm Phase II investigation into the safety and efficacy of transdermal cannabidiol (CBD) delivered using GT4 skin bream technology in individuals diagnosed with Dravet and/or Lennox-Gastatu syndrome (DS and/or LGS). We aim to enroll 25 participants between the ages of 2 and 55 diagnosed with DS and/or LGS. Transdermal delivery of cannabinoids may provide advantages over other traditional routes of administration. Noted advantages include avoidance of first pass metabolism which mitigates potentially dangerous drug-drug interactions due to delayed cannabinoid accumulation, and more stable and constant plasma cannabinoid concentrations. GT4 technology, uses emulsion technology containing penetrating agents, basement membrane disruptors, and vasodilators to overcome hydrophilic and lipophilic structures to open channels and transport cannabinoids deep into the dermis layer of the skin. Once in the dermis, vasodilators dilate the capillary bed to increase fluid dynamic flow into and out of the application site, delivering cannabinoids into the blood stream. The primary objective is to investigate the safety and efficacy of CBD delivery with the A-Synaptic GT4 Transdermal Delivery System in individuals diagnosed with DS and/orLGS. Dr. Rotenberg will apply for and hold the expanded access IND for this study, as the sponsor is running this study as an investigator-initiated study. The study consists of 11 visits over \~160 days, dosing begins at Visit #2.

First Posted: 2024-12-18

Condition(s): Lennox-Gastaut Syndrome (LGS), Dravet Syndrome (DS)

Intervention(s): CBD: GT4 Transdermal Delivery System

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 25

Allocation: NA

Sponsor: Alexander Rotenberg

Principal Investigator: Alexander Rotenberg, Professor of Neurology, Harvard Medical School

Completion Date (primary or actual): 2027-01

CT.gov Identifier: NCT06738732

Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.

First Posted: 2021-11-24

Condition(s): Posttraumatic Stress Disorder, Stress Disorders, Post-Traumatic

Intervention(s): Cannabidiol (CBD) oral solution, Placebo, Massed Prolonged Exposure (mPE)

Status: COMPLETED

Enrollment (expected or actual): 21

Allocation: RANDOMIZED

Sponsor: The University of Texas Health Science Center at San Antonio

Principal Investigator: Casey Straud, Assistant Professor

Completion Date (primary or actual): 2023-06-30

CT.gov Identifier: NCT05132699

Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compared to Healthy Controls With PET (18F-RoSMALS)

This clinical trial is a phase 1 study in which investigations with the weakly radioactive substance \[18F\]-RoSMA-18-d6 are being carried out for the first time. This radiolabeled substance will be used to study a specific protein in the brain and spinal cord of patients with ALS and healthy individuals. This particular protein, the cannabinoid type 2 receptor, is thought to play a role in the disease process of ALS. Furthermore, it is assumed that this protein is found more frequently in the brain and spinal cord of patients with ALS compared to healthy individuals. The following questions will be answered by this clinical trial. 1. Is this protein found, as suspected, increased in the brain and spinal cord of ALS patients compared to healthy individuals ? 2. Does the amount of this protein change during the course of the disease? 3. Are there any correlations between the observed changes in the amount of protein and the assessment of the course of the disease?

First Posted: 2023-05-30

Condition(s): Amyotrophic Lateral Sclerosis

Intervention(s): [18F]-RoSMA-18-d6

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: NON_RANDOMIZED

Sponsor: Markus Weber

Principal Investigator: Markus Weber, Prof. Dr. med.

Completion Date (primary or actual): 2026-09

CT.gov Identifier: NCT05880563

Medical Cannabis as an Opiate Alternative

Medical Cannabis is very safe and a viable option for pain relief to improve patients and their family's quality of life. However, medical cannabis is not covered by insurance and is an out of pocket expense. This has been a barrier to some patients trying medical cannabis as an alternative. Recruitment and inclusion/exclusion criteria: Potential participants will be recruited from an outpatient chronic pain clinic. 40 patients who have agreed to attempt wean down on opioid medication and have a diagnosis which qualifies them for medical marijuana will be selected for the study. In these selected patients, cost of the treatment was the main barrier for starting medical cannabis. Each participant will undergo a urine drug screen, a pain assessment using the visual analog scale and pain quality will be assessed using the Short Form-36 health related quality, prior to receiving medical cannabis. Each patient will have an individualized plan for weaning off their opioids which is their standard care plan. The patient will go to the select medical cannabis dispensary. The patient will be followed up monthly for five months by physician and will assess the patient's pain levels and Medical Cannabis doses and opioid doses monthly. The investigators will also note the patient side effects, tolerance and any decrease in symptoms. At five months the physician will recheck a urine drug screen, current pain level and readminister the Short form-36 health related quality. The Medical Cannabis doses and strains will be noted.

First Posted: 2025-09-26

Condition(s): Chronic Pain, Opioid Use

Intervention(s): We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.

Status: COMPLETED

Enrollment (expected or actual): 29

Allocation:

Sponsor: University of Pennsylvania

Principal Investigator: Franklin Caldera, Professor of Physical Medicine and Rehabilitation

Completion Date (primary or actual): 2025-10-01

CT.gov Identifier: NCT07194928

Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain

The aim of this study is to compare the effectiveness of combined treatment with paravertebral oxygen-ozone injections and topical patches containing Cannabidiol and β-Caryophyllene in patients with neck pain by evaluating the following aspects: * Reduction of pain * Reduction of disability associated with neck pain

First Posted: 2023-10-25

Condition(s): Neck Pain

Intervention(s): Cannabidiol and β-Caryophyllene Patch, Oxygen-Ozone Therapy

Status: UNKNOWN

Enrollment (expected or actual): 52

Allocation: RANDOMIZED

Sponsor: Humanitas Clinical and Research Center

Principal Investigator: Cristiano Sconza, Principal Investigator

Completion Date (primary or actual): 2025-03-01

CT.gov Identifier: NCT06099171

A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.

First Posted: 2015-09-09

Condition(s): Tuberous Sclerosis Complex, Seizures

Intervention(s): GWP42003-P, Placebo

Status: COMPLETED

Enrollment (expected or actual): 224

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2019-02-26

CT.gov Identifier: NCT02544763

tDCS as Treatment for Motor Function

Previous preliminary results are sufficiently impressive to suggest that tDCS stimulation does have the potential to improve motor function when that ability is trained during stimulation. In the proposed study, the investigation will assess whether walking sessions combined with tDCS lead to improvements in motor function: gait, articulation, eye gaze, and motor dexterity. In addition, the investigators wish to examine if such results can be replicated in people with other conditions, such as cortical basal syndrome, and Parkinson's disease.

First Posted: 2025-12-18

Condition(s): Progressive Supranuclear Palsy, Cortical Basal Ganglionic Degeneration, Parkinson Disease

Intervention(s): Transcranial direct current stimulation (TDCS), Stimulation Arm

Status: RECRUITING

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Baycrest

Principal Investigator: Tyler Roncero, Principle Investigator

Completion Date (primary or actual): 2030-12

CT.gov Identifier: NCT07291687

Effect of Quetiapine on Marijuana Withdrawal and Relapse

The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.

First Posted: 2008-08-28

Condition(s): Marijuana Smoking

Intervention(s): Marijuana, Quetiapine, Placebo oral capsule

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator:

Completion Date (primary or actual): 2009-03

CT.gov Identifier: NCT00743366

N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms

This study investigates the effects of repeated NAC administration on glutamate concentrations in the anterior cingulate cortex (ACC), on neurocognitive functioning, and on neuro-inflammatory parameters in adult cannabis-dependent individuals.

First Posted: 2017-07-18

Condition(s): Cannabis Use Disorder, Cannabis Dependence

Intervention(s): N-acetylcysteine, Placebo Oral Tablet, Magnetic Resonance Imaging, Neurocognitive measures, Neuro-inflammatory measures

Status: UNKNOWN

Enrollment (expected or actual): 75

Allocation: RANDOMIZED

Sponsor: Universitair Ziekenhuis Brussel

Principal Investigator:

Completion Date (primary or actual): 2023-02-01

CT.gov Identifier: NCT03221231

CBD Effects on Periodontal Health of Patients With Chronic Periodontitis

The suppression of chronic periodontitis after application of dental gel and toothpaste containing cannabidiol (CBD) will be evaluated.

First Posted: 2022-08-11

Condition(s): Chronic Periodontitis

Intervention(s): placebo dental gel, placebo toothpaste, Cannabidiol dental gel, Cannabidiol toothpaste, Placebo toothpaste, Corsodyl dental gel

Status: COMPLETED

Enrollment (expected or actual): 90

Allocation: RANDOMIZED

Sponsor: Palacky University

Principal Investigator: Jan Vacek, Department of Dentistry, Olomouc University Hospital

Completion Date (primary or actual): 2022-02-01

CT.gov Identifier: NCT05498012

Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in Healthy Chinese Subjects

In this trial, 32 healthy subjects are planned to be enrolled in fasting and 36 healthy subjects are planned to be enrolled in postprandial, and the fasting and postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout period (dosing interval) between doses will be at least 5 days. Taking the washout period of 5 days as an example, all subjects will take the corresponding medication according to the randomization table on day 1 of the first cycle trial, day 6 of the second cycle trial, day 11 of the third cycle trial, and day 16 of the fourth cycle trial.

First Posted: 2023-08-04

Condition(s): Healthy

Intervention(s): Test (T) Entacapone,Levodopa and Carbidopa Tablets (II), Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)

Status: UNKNOWN

Enrollment (expected or actual): 68

Allocation: RANDOMIZED

Sponsor: The Affiliated Hospital of Qingdao University

Principal Investigator:

Completion Date (primary or actual): 2024-07-12

CT.gov Identifier: NCT05976737

Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms

Background: \- Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment ( spontaneous quitting). Studies have suggested that there are some common strategies that many individuals use in spontaneous quitting, such as changing one s lifestyle or identity, reminding oneself of negative consequences, support from family and friends, and religion. However, more research is needed to determine potential treatment strategies for marijuana use. Objectives: * To identify strategies used to help with marijuana quitting among non-treatment seeking adult marijuana users. * To identify withdrawal symptoms experienced during marijuana quitting and their relationship to the quitting strategies used and the outcome of the quit attempt. * To evaluate whether subgroups of marijuana users differ in their experience of marijuana quitting. Eligibility: \- Individuals at least 18 years of age who have made at least one attempt to quit marijuana use. Design: * The study will consist of one visit of approximately 1 to 2 hours. * Participants will fill out three questionnaires. The questionnaires have different types of questions, and will ask about background and lifestyle, marijuana use and craving patterns and behaviors, and difficulties in previous attempts to quit using marijuana.

First Posted: 2012-05-23

Condition(s): Cannabis Abuse, Cannabis Dependence

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 822

Allocation:

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2012-05-03

CT.gov Identifier: NCT01603992

A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety

This open-label to double-blind study evaluates the impact of cannabidiol (CBD) on anxiety in adults. Participants will use a custom-formulated sublingual (under-the-tongue) solution of whole plant, hemp-derived CBD twice daily for six weeks in addition to their normal treatment regimen. Participants' clinical state will be assessed weekly during the treatment period. Quality of life, sleep, general health, and cognitive function will also be assessed.

First Posted: 2020-02-27

Condition(s): Anxiety

Intervention(s): CBD

Status: TERMINATED

Enrollment (expected or actual): 15

Allocation: NA

Sponsor: Mclean Hospital

Principal Investigator: Staci Gruber, Ph.D., Director, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery

Completion Date (primary or actual): 2023-08-24

CT.gov Identifier: NCT04286594

RCT of the Double Wire Technique for Sphincterotomy

Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening. Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct then it might be a better way to approach the patient whom we had difficulty in entering the bile duct.

First Posted: 2013-02-15

Condition(s): Cholangiopancreatography, Endoscopic Retrograde, Sphincterotomy, Endoscopic, VATER'S AMPULLA

Intervention(s): Transpancreatic sphincterotomy

Status: TERMINATED

Enrollment (expected or actual): 16

Allocation: RANDOMIZED

Sponsor: Mayo Clinic

Principal Investigator: Douglas O. Faigel, Gastroenterologist

Completion Date (primary or actual): 2016-11

CT.gov Identifier: NCT01792466

Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain

The purpose of the study is to evaluate whether Pure Green tablets is a better pain reliever for the treatment of mild to moderate musculoskeletal pain.

First Posted: 2019-12-10

Condition(s): Musculoskeletal Pain

Intervention(s): Cannabidiol (CBD)

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: NA

Sponsor: Pure Green

Principal Investigator:

Completion Date (primary or actual): 2019-12-09

CT.gov Identifier: NCT04193631

Cannabis Use Disorder Treatment Study

The purpose of this study is to test a text-delivered counseling program to stop or reduce cannabis use among young adults (ages 18 to 25).

First Posted: 2020-09-28

Condition(s): Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): Peer Network Counseling-txt

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 1077

Allocation: RANDOMIZED

Sponsor: The University of Tennessee, Knoxville

Principal Investigator: Michael Mason, Principal Investigator

Completion Date (primary or actual): 2026-05-31

CT.gov Identifier: NCT04567394

Nabilone for Non-motor Symptoms in Parkinson's Disease

This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease (PD). Nabilone is an analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and therefore mimics the effect of THC but with more predictable side effects and less euphoria. Eligible patients will be re-tapered in an open-label nabilone dose optimization phase followed by an open-label period of 6 months on a stable nabilone dose.

First Posted: 2018-12-12

Condition(s): Parkinson Disease

Intervention(s): Nabilone 0.25 mg

Status: COMPLETED

Enrollment (expected or actual): 22

Allocation: NA

Sponsor: Medical University Innsbruck

Principal Investigator: Klaus Seppi, MD, Principal Investigator

Completion Date (primary or actual): 2020-01-31

CT.gov Identifier: NCT03773796

Cannabis Use Registry to Improve Overall Understanding of Symptoms (CURIOUS)

Through partnership with Ontracka, the HealthPartners Institute Cancer Research Center created a secure and compliant app-based technology with the ability to seamlessly collect patient-level data on symptoms, cannabis use, real-time response to cannabis consumption, and patient-reported changes in supportive care medications such as opioids and antiemetics. By joining this registry, patients will have access to expert cannabis education, dosing recommendations, and easy symptom tracking. Patients with cancer and their oncology clinicians can utilize this reliable, cancer-specific data to help them make informed decisions together about how cannabis could be incorporated into a treatment plan. To learn more and sign up, visit https://study.ontracka.com/cannabiscurious

First Posted: 2025-11-12

Condition(s): Cannabis Use, Cancer

Intervention(s):

Status: RECRUITING

Enrollment (expected or actual): 1000

Allocation:

Sponsor: HealthPartners Institute

Principal Investigator:

Completion Date (primary or actual): 2028-04

CT.gov Identifier: NCT07227324

Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults

Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, and suicide screening is completed throughout.

First Posted: 2022-03-08

Condition(s): PTSD

Intervention(s): Cannabidiol Administered as Nantheia ATL5, Placebo

Status: RECRUITING

Enrollment (expected or actual): 140

Allocation: RANDOMIZED

Sponsor: University of Nebraska

Principal Investigator:

Completion Date (primary or actual): 2029-04

CT.gov Identifier: NCT05269459

Teen Health Choices & Wellness

The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.

First Posted: 2025-02-12

Condition(s): Health Behavior, Wellness, Psychological, Substance Use

Intervention(s): Cue reactivity paradigm

Status: RECRUITING

Enrollment (expected or actual): 224

Allocation: NA

Sponsor: Brown University

Principal Investigator:

Completion Date (primary or actual): 2028-02

CT.gov Identifier: NCT06822569

Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease

Observational cross-sectional study in PD patients and healthy controls (HC) using an investigational medical device consisting of a passive small intestine microbiome aspiration (SIMBA) system (capsule) that is ingested orally and recovered together with the stools (home recovery) together with blood sampling (during the onsite visit).

First Posted: 2023-08-22

Condition(s): Parkinson Disease

Intervention(s): Fluid biopsy capsule, Levodopa-Carbidopa Immediate Release

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 100

Allocation:

Sponsor: Nimble Science Ltd.

Principal Investigator:

Completion Date (primary or actual): 2025-02

CT.gov Identifier: NCT06003608

Home-Based Quadriceps Isometric Exercise for Knee Osteoarthritis Pain

Knee osteoarthritis is a common cause of pain and reduced mobility in older adults. Many people have limited access to supervised rehabilitation programs, highlighting the need for simple and safe home-based treatment options. This study evaluates whether a brief home-based quadriceps isometric exercise program can reduce knee pain in community-dwelling older adults. Participants perform short daily muscle contractions of the thigh muscles for 28 days. In addition, participants are assigned to receive one of four topical formulations (placebo, cannabidiol, arnica, or a combination of cannabidiol and arnica) to explore whether these products modify the exercise response. The primary outcome is change in knee pain intensity measured using a visual analog scale. Secondary outcomes include adherence and safety. This pilot study aims to assess the feasibility, safety, and preliminary effectiveness of this low-cost and easily accessible strategy to inform future larger clinical trials.

First Posted: 2026-03-03

Condition(s): Older Adults (60 - 85 Years Old), OA Knee

Intervention(s): Placebo Topical Gel, Cannabidiol (CBD) Topical Gel, Arnica montana Topical Gel, Home-based Quadriceps Isometric Exercise, CBD + Arnica Topical Gel

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Universidad del Valle de México, Campus Cuernavaca

Principal Investigator:

Completion Date (primary or actual): 2025-11-01

CT.gov Identifier: NCT07445568

Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 MME within 24 hours of admission, followed by a 24 hour screening/randomization window and a participation period extending through the acute hospitalization period. A total of 122 adult patients admitted with a traumatic injury will be randomized 1:1 across 2 study arms: adjunctive dronabinol or systemic analgesics only. Patients randomized to the dronabinol arm should receive their first dose within 12 hours of randomization; patients will also receive PRN as needed systemic analgesics for pain. Except for the analgesia protocol, all other interventions will be equivalent for participants in both arms. The clinical effects of analgesia treatment arm will be evaluated during the acute hospitalization (hospital admission through discharge or death). The primary efficacy endpoint will be assessed starting at 48 hours after randomization and carried through to discharge.

First Posted: 2019-04-25

Condition(s): Traumatic Injury, Pain, Acute

Intervention(s): Adjunctive dronabinol, Systemic analgesics

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: CommonSpirit Health

Principal Investigator: Claire Swartwood, Pharmacy Residency Program Director

Completion Date (primary or actual): 2021-06-29

CT.gov Identifier: NCT03928015

PET Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP

The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders.

First Posted: 2008-01-21

Condition(s): Healthy

Intervention(s): [11C]MePPEP

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation: NON_RANDOMIZED

Sponsor: National Institute of Mental Health (NIMH)

Principal Investigator:

Completion Date (primary or actual): 2013-01-22

CT.gov Identifier: NCT00598390

Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients

Anorexia is common symptom in cancer patients and is associated with increased morbidity and mortality. However timely detection with objective tools is necessary to establish the diagnosis of anorexia and to assess the magnitude of change over time. The anorexia pathophysiology is not clearly understood and treatment options are limited. Anecdotal historical benefits of smoking marijuana on nausea, pain and anorexia led to studies with marijuana and synthetic cannabinoids from Δ-9-tetrahydrocannabinol, the main active agent in marijuana. The endogenous cannabinoid system with its receptors CB1 and CB2 regulate appetite in four functional levels: (1) limbic system (hedonistic quality), (2) hypothalamus (appetite stimulant), (3) intestinal, and (4) tissue adipose. Nabilone, a synthetic analogue of THC approved in Mexico for nausea and vomiting induced by chemotherapy is also used in palliative care units for clinical improvement in increased appetite patients in terminal stages, however, there are no clinical trials demonstrating this benefit.

First Posted: 2016-06-16

Condition(s): Non-Small Cell Lung Cancer, Anorexia, Cachexia, Weight Lose

Intervention(s): Nabilone, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 78

Allocation: RANDOMIZED

Sponsor: Instituto Nacional de Cancerologia de Mexico

Principal Investigator: Oscar Gerardo Arrieta Rodríguez MD, MD M Sc

Completion Date (primary or actual): 2017-07

CT.gov Identifier: NCT02802540

Transcranial Magnetic Stimulation for Adolescents and Young Adults With Cannabis Use Disorder

This pilot study will investigate the potential of repetitive transcranial magnetic stimulation (rTMS) to strengthen a neural circuit critical for maintaining abstinence in adolescents and youth with cannabis use disorder (CUD).

First Posted: 2026-06-09

Condition(s): Cannabis Use, Cannabis Use Disorder

Intervention(s): Magstim SuperRapid2, Sham rTMS

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: University of Minnesota

Principal Investigator:

Completion Date (primary or actual): 2029-03-31

CT.gov Identifier: NCT07634835

Baby Detect : Genomic Newborn Screening

Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life. Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.

First Posted: 2023-01-18

Condition(s): Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1, Phosphoglucomutase 1 Deficiency, Maturity Onset Diabetes of the Young, Cystic Fibrosis, Hypophosphatasia, Infantile, Congenital Hypothyroidism, Deficit in Anterior Pituitary Function and Variable Immunodeficiency, Pituitary Hormone Deficiency, Combined, Diamond Blackfan Anemia, Wiskott-Aldrich Syndrome, Fanconi Anemia, Hemophilia A, Hemophilia B, Glucose 6 Phosphate Dehydrogenase Deficiency, Alpha-Thalassemia, Sickle Cell Disease, Shwachman-Diamond Syndrome, Alpha 1-Antitrypsin Deficiency, Inflammatory Bowel Disease 25, Autosomal Recessive, Wilson Disease, Progressive Familial Intrahepatic Cholestasis, Crigler-Najjar Syndrome, Familial Chylomicronemia, Lysosomal Acid Lipase Deficiency, Familial Hemophagocytic Lymphocytosis, Griscelli Syndrome, Chediak-Higashi Syndrome, Severe Congenital Neutropenia, Severe Combined Immune Deficiency, Chronic Granulomatous Disease, Menkes Disease, Adrenoleukodystrophy, Smith-Lemli-Opitz Syndrome, Ataxia With Vitamin E Deficiency, Thiamine Metabolism Dysfunction Syndrome 5 (Episodic Encephalopathy Type), Thiamine Metabolism Dysfunction Syndrome 4 (Bilateral Striatal Degeneration and Progressive Polyneuropathy Type), Thiamine-Responsive Megaloblastic Anemia, Thiamine Metabolism Dysfunction Syndrome 2, Deficiency of GOT2, Cerebral Folate Transport Deficiency, Segawa Syndrome, Autosomal Recessive, Congenital Myasthenic Syndrome, Metachromatic Leukodystrophy, Sepiapterin Reductase Deficiency, Dopamine Beta Hydroxylase Deficiency, Glut1 Deficiency Syndrome, Late-Infantile Neuronal Ceroid Lipofuscinosis, Aromatic L-amino Acid Decarboxylase Deficiency, Charcot-Marie-Tooth Disease, Type 6C, Hereditary Hyperekplexia, Brain Dopamine-Serotonin Vesicular Transport Disease, Very Long Chain Hydroxy Acyl Dehydrogenase Deficiency, Tyrosinemia, Type I, Disaccharide Intolerance I, Beta Ketothiolase Deficiency, Phosphoglycerate Dehydrogenase Deficiency, Succinyl-Coa:3-Ketoacid Coa-Transferase Deficiency, Pyridoxine-5'-Phosphate Oxidase Deficiency, Pyridoxine-Dependent Epilepsy, Propionic Acidemia, Pompe Disease, Phenylalanine Hydroxylase Deficiency, Ornithine Transcarbamylase Deficiency, N Acetyl Glutamate Synthetase Deficiency, Riboflavin Deficiency, Maple Syrup Urine Disease, Medium Chain Acyl CoA Dehydrogenase Deficiency, Malonic Acidemia, Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency, Isovaleric Acidemia, Phosphoserine Aminotransferase Deficiency, Phosphoserine Phosphatase Deficiency, Hyperornithinemia-Hyperammonemia-Homocitrullinuria, S-Adenosylhomocysteine Hydrolase Deficiency, Mucopolysaccharidosis VII, Mucopolysaccharidosis VI, Mucopolysaccharidosis IV A, Mucopolysaccharidosis II, Mucopolysaccharidosis I, Transcobalamin Deficiency, Isolated Methylmalonic Acidemia, Cobalamin Deficiency, Homocystinuria, Holocarboxylase Synthetase Deficiency, Fanconi Bickel Syndrome, Glycogen Storage Disease, Glycine Encephalopathy, Glutaric Acidemia I, Glucose Galactose Malabsorption, Gaucher Disease, Type 1, Galactosemias, Fructosemia, Fructose-1,6-Diphosphatase Deficiency, Carbamoyl Phosphate Synthase 1 Deficiency, Citrullinemia Type II, Citrullinemia 1, Creatine Deficiency Syndrome, Systemic Primary Carnitine Deficiency, Carnitine Palmitoyltransferase Deficiency 2, Carnitine Palmitoyltransferase Deficiency 1, Carnitine Acylcarnitine Translocase Deficiency, Riboflavin Transporter Deficiency, Branched-Chain Keto Acid Dehydrogenase Kinase Deficiency, Andersen Tawil Syndrome, Timothy Syndrome, Jervell-Lange Nielsen Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia, Familial Hypertrophic Cardiomyopathy Type 4, Pseudohypoaldosteronism, Type II, Pseudohypoaldosteronism Type 1, Primary Hyperoxaluria, X Linked Hypophosphatemia, Hereditary Nephrogenic Diabetes Insipidus, Cystinosis, Congenital Nephrotic Syndrome, Finnish Type, Alport Syndrome, Hereditary Retinoblastoma, Biotinidase Deficiency, Aciduria, Argininosuccinic, Argininemia, Acyl-CoA Dehydrogenase Family, Member 9, Deficiency of, 3-Hydroxy 3-Methyl Glutaric Aciduria, 3-Hydroxy-3-Methylglutaryl-CoA Synthase 2 Deficiency

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 6824

Allocation:

Sponsor: Centre Hospitalier Universitaire de Liege

Principal Investigator: Laurent Servais, Professor

Completion Date (primary or actual): 2025-06-02

CT.gov Identifier: NCT05687474

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test

The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. This randomized, placebo-controlled, double-blind study is designed as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001 during a THC challenge. Results of this study will inform the future potential use of ANEB-001 as an emergency treatment for acute cannabinoid intoxication.

First Posted: 2022-03-16

Condition(s): Acute Cannabinoid Intoxication

Intervention(s): ANEB-001, Placebo

Status: COMPLETED

Enrollment (expected or actual): 154

Allocation: RANDOMIZED

Sponsor: Anebulo Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2023-08-26

CT.gov Identifier: NCT05282797

Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents

This research is studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.

First Posted: 2010-07-27

Condition(s): Risk Reduction Behavior, Health Behavior, Sexual Behavior, Adolescent Behavior, Cannabis

Intervention(s): INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY), SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH), SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION

Status: COMPLETED

Enrollment (expected or actual): 460

Allocation: RANDOMIZED

Sponsor: University of New Mexico

Principal Investigator:

Completion Date (primary or actual): 2014-06

CT.gov Identifier: NCT01170260

Cannabidiol Oil for Treatment-Resistant Major Depression

Major depressive disorder is one of the leading causes of disability worldwide, and a substantial proportion of patients do not achieve adequate improvement with conventional antidepressant treatments. Cannabidiol (CBD), a non-intoxicating cannabinoid derived from Cannabis sativa, has shown potential anxiolytic, anti-inflammatory, and neurobiological effects that may be relevant for depressive disorders. The ANANDA trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety, and tolerability of full-spectrum cannabidiol oil as an adjunctive treatment in adults with treatment-resistant major depressive disorder. A total of 120 participants will be randomly assigned to receive either full-spectrum cannabidiol oil or placebo for 12 weeks while maintaining stable antidepressant treatment. Clinical assessments of depressive symptoms, anxiety, sleep quality, perceived stress, and adverse effects will be performed at baseline, Week 4, and Week 12. Blood samples will be collected at baseline and after 12 weeks to investigate inflammatory and neuroendocrine biomarkers. The primary objective is to evaluate changes in depressive symptoms after 12 weeks of treatment. Secondary objectives include the assessment of anxiety, sleep quality, perceived stress, biological markers, safety, and tolerability. The findings of this study may contribute to the development of new therapeutic approaches for treatment-resistant depression and provide additional evidence regarding the clinical use of cannabidiol in psychiatric disorders.

First Posted: 2026-07-10

Condition(s): Major Depressive Disorder (MDD), Treatment-resistant Depression (TRD)

Intervention(s): Full-spectrum CBD oil 100 mg/mL, Placebo oil (MCT oil)

Status: RECRUITING

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: Universidade do Sul de Santa Catarina

Principal Investigator: Rafael Mariano de Bitencourt, Principal Investigator

Completion Date (primary or actual): 2026-12-31

CT.gov Identifier: NCT07696871

The Effects of CBD Isolate on Menstrual-Related Symptoms

The goal of this open-label clinical trial is to compared two different doses for treating menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring for 4-8 days every 21-28 days). The main question it aims to answer is: (1) if there are changes in menstrual-related symptoms from baseline compared to all 3-months of cannabidiol (CBD) isolate consumption. Participants will complete a monthly baseline measure after they stop menstruating followed by taking CBD twice daily (BID) for five days for three menstrual cycles and complete the same measures. Researchers will compare 160mg of daily CBD isolate to 320mg of CBD isolate to see if there are differential effects on menstrual-related symptoms (MRS).

First Posted: 2023-01-11

Condition(s): Menstrual Discomfort

Intervention(s): Cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 33

Allocation: RANDOMIZED

Sponsor: Canopy Growth Corporation

Principal Investigator:

Completion Date (primary or actual): 2021-09-23

CT.gov Identifier: NCT05679830

A Brief Cannabis Use Psychoeducation Intervention for Eating Disorder Patients

The goal of this clinical trial is to learn if providing eating disorder patients with education about the consequences of cannabis (marijuana) use on mental health, gastrointestinal symptoms, eating disorder symptoms, and eating disorder treatment effectiveness increases their knowledge about the cannabis use consequences, intention to reduce cannabis use, and motivation to seek treatment for their cannabis use. The main questions this study aims to answer are: 1. Does education about consequences of cannabis use increase eating disorder patients' knowledge about the risks of cannabis use? 2. Does education about the consequences of cannabis use increase intention to reduce cannabis use and seek cannabis use treatment among those with eating disorders? 3. Does cannabis use interfere with how successful eating disorder treatment is for eating disorder patients? All participants will receive 20 weeks of eating disorder treatment. In week 1 of treatment, participants will either be assigned to receive education about cannabis use consequences, or be assigned to a control condition where they receive education about consequences of poor sleep. Participants will be asked to complete a number of questionnaires that measure knowledge about cannabis use consequences, intention to reduce use and seek cannabis use treatment, eating disorder symptoms, and cannabis use habits. Researchers will assess how effective providing education about cannabis use consequences is on changing knowledge about cannabis use risks, intention to reduce use, and intention to seek cannabis use treatment. It will also be examined if effectiveness of eating disorder treatment is related to cannabis use habits.

First Posted: 2026-02-04

Condition(s): Eating Disorders, Cannabis Use

Intervention(s): Psychoeducation about risks of cannabis use, Placebo control: Sleep hygiene psychoeducation

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: St. Joseph's Healthcare Hamilton

Principal Investigator: Sarah McComb, Principal Investigator

Completion Date (primary or actual): 2028-02-04

CT.gov Identifier: NCT07387965

Cannabis Oil for Pain Effectiveness

This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.

First Posted: 2018-05-11

Condition(s): Cancer, Chronic Pain

Intervention(s): MRCP001

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: NA

Sponsor: Aurora Cannabis Inc

Principal Investigator:

Completion Date (primary or actual): 2020-09

CT.gov Identifier: NCT03522467

Contribution of Pathological Alpha-synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies

Alzheimer's disease and dementia with Lewy bodies (DLB) are the two main age-related neurodegenerative cognitive disorders. Differential diagnosis between these conditions is challenging, both at the prodromal and dementia stages. The lack of a precise diagnosis can be particularly harmful for patients with DLB, as up to 80% of them show severe adverse reactions to antipsychotic medications, including falls, confusion, and even death. The diagnosis of Alzheimer's disease has improved with cerebrospinal fluid (CSF) biomarkers such as Tau, phosphorylated Tau (P-Tau), and the Aβ42/Aβ40 ratio (Lehmann et al., 2018). However, differentiating Alzheimer's disease from DLB remains difficult: 1 to 3 Alzheimer's biomarkers are frequently positive in the CSF of patients with DLB: in 49% of cases at the prodromal stage and up to 72% at the dementia stage. Moreover, total α-synuclein measurement in CSF has not proven to be diagnostically reliable. The DAT-scan, sometimes used as a supportive tool, is an expensive technique and lacks sensitivity, with detection rates of only 78% in dementia-stage DLB and 54% in prodromal DLB. Given these limitations, identifying specific biomarkers for DLB, particularly pathological α-synuclein, is a critical objective. α-synuclein is the main protein component of Lewy bodies, whose abnormal β-sheet conformation promotes aggregation and prion-like propagation. Conventional measurements of total α-synuclein in CSF have failed to achieve sufficient diagnostic specificity. In contrast, detecting aggregated or pathological forms of α-synuclein in CSF appears to be a promising approach for improving the diagnosis of synucleinopathies. New techniques based on α-synuclein aggregation amplification have shown encouraging results in retrospective studies including neuropathologically confirmed cases (Bargar et al., 2021; Rossi et al., 2020). However, prospective evaluation of these methods in real-world clinical settings is still lacking. We hypothesize that a specific assay targeting pathological α-synuclein in CSF could reliably distinguish patients with DLB from those with Alzheimer's disease.

First Posted: 2025-09-10

Condition(s): Dementia With Lewy Bodies (DLB), Alzheimer's Disease (AD)

Intervention(s): Biological : blood sampling, nasopharyngeal swab, Procedure : Lumbar puncture, Behavioral : clinical, functional, cognitive and psychiatric evaluations, MRI

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 286

Allocation: NON_RANDOMIZED

Sponsor: University Hospital, Strasbourg, France

Principal Investigator:

Completion Date (primary or actual): 2032-01-01

CT.gov Identifier: NCT07166744

Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease

The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.

First Posted: 2009-06-04

Condition(s): Parkinson's Disease

Intervention(s): Levodopa infusion

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: NA

Sponsor: University of Helsinki

Principal Investigator:

Completion Date (primary or actual): 2011-01

CT.gov Identifier: NCT00914134

A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders

The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD. The main question it aims to answer is whether treatment with nabiximols improves patient-reported spasticity ratings compared to treatment with a placebo. This trial will also answer whether nabiximols impact pain, spasm frequency, mood, walking ability, and sleep. Participants will be mailed the treatments and placebo treatments, and will be asked to complete study visits and questionnaires remotely. There is also an optional sub-study that involves in-person visits with ultrasound imaging and in-person neurologic exams.

First Posted: 2023-08-03

Condition(s): NMO Spectrum Disorder, Spasticity, Muscle

Intervention(s): Nabiximols, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Michael, Levy M.D.,Ph.D.

Principal Investigator: Michael, Levy M.D.,Ph.D., Associate Professor of Neurology at Massachusetts General Hospital

Completion Date (primary or actual): 2027-09-30

CT.gov Identifier: NCT05974293

Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)

This prospective observational study aims to describe the effectiveness of MC on pain, epilepsy, sleep and /or anxiety/depression in a cohorts of patients authorized to use MC, using pre-defined, validated self assessment scales.

First Posted: 2020-08-25

Condition(s): Pain, Sleep, Anxiety, Depression, Epilepsy

Intervention(s): Medical Cannabis

Status: RECRUITING

Enrollment (expected or actual): 1000

Allocation:

Sponsor: University Health Network, Toronto

Principal Investigator:

Completion Date (primary or actual): 2028-07

CT.gov Identifier: NCT04526093

PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK

Progressive Supranuclear Palsy (PSP), Cortico-Basal Degeneration (CBD) and Multiple System Atrophy (MSA) are degenerative brain conditions for which there are currently no curative treatments. To aid the development of new treatment trials, there is a pressing need to develop better methods for diagnosing these conditions early, and to track disease progression. The PROSPECT-M-UK study will collect standardised clinical data over time. Patients will also have the option to have a brain MRI scan, eye movement exam and donate blood, skin and spinal fluid samples, with the aim to identify "biomarkers" that can improve the accuracy of early diagnosis and track the natural time course of disease. Control participants and those not meeting criteria for Parkinson's disease or other defined conditions but are considered by the investigator group to be allied syndromes or at risk states (atypical parkinsonian syndromes), will also be examined. Patients can also participate via the CBD European registry or in a one-off study assessment through the cross-sectional study, which involves completing questionnaires and a blood sample donation.

First Posted: 2016-05-20

Condition(s): Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration, Multiple System Atrophy (MSA)

Intervention(s):

Status: UNKNOWN

Enrollment (expected or actual): 900

Allocation:

Sponsor: University College, London

Principal Investigator:

Completion Date (primary or actual): 2023-07

CT.gov Identifier: NCT02778607

Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Parkinson's disease (PD) is one of the most common neurodegenerative diseases characterized by the progressive loss of dopaminergic (DA) neurons in the substantia nigra compacta (SNc) and aggregation of Lewy bodies in neurons. Although aging, oxidative damage and neuroinflammation have been recognized to play crucial roles in the pathogenesis of PD, the precise etiology remains obscure. Emerging evidence suggests PD is a systemic metabolic disease, and metabolic abnormality correlates with functional alternations in PD

First Posted: 2023-03-23

Condition(s): Parkinson Disease

Intervention(s): levodopa-carbidopa, Metformin

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Tanta University

Principal Investigator: Mostafa Bahaa, Teaching Assistant

Completion Date (primary or actual): 2025-01-20

CT.gov Identifier: NCT05781711

Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)

This study is designed to evaluate an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

First Posted: 2024-12-16

Condition(s): Insomnia, Alcohol Use, Marijuana Use

Intervention(s): Brief Behavioral Therapy for Insomnia (BBTI), Brief Alcohol Screening and Intervention for College Students (BASICS), Attention Control

Status: RECRUITING

Enrollment (expected or actual): 800

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Mary Larimer, Professor, Department of Psychiatry and Behavioral Sciences

Completion Date (primary or actual): 2029-04-01

CT.gov Identifier: NCT06736444

Pregnenolone for Cannabis Use Disorder and Depression

This is UG3 phase of a multi-site, milestone-driven UG3/UH3 research program evaluating pregnenolone for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms. The primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. Key preparatory activities include obtaining regulatory approvals (including FDA Investigational New Drug \[IND\] protocol amendment and Institutional Review Board approvals), harmonizing study procedures across participating sites, and implementing data management and monitoring systems. The UG3 phase includes two main components. First, a pharmacokinetic study willcharacterize pregnenolone pharmacokinetics in adults with CUD and MDD, including measures such as half-life and clearance. Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks. Feasibility outcomes include recruitment rates, retention, and adherence to study procedures, while safety and tolerability will be assessed through adverse event monitoring and discontinuation rates. Participants will be adults aged 18 to 50 years with diagnoses of cannabis use disorder and major depressive disorder, who report frequent cannabis use and express interest in reducing their use. Clinical assessments of cannabis use, mood symptoms, and related behavioral outcomes will be collected. The UG3 phase will be used to refine study procedures, inform dosing strategies, and establish benchmarks necessary for progression to the UH3 phase. The subsequent UH3 phase will involve a multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy of pregnenolone in reducing cannabis use and improving depressive symptoms in this population.

First Posted: 2026-07-06

Condition(s): Cannabis Use Disorder, Major Depressive Disorder (MDD)

Intervention(s): Pregnenolone

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: University of Texas Southwestern Medical Center

Principal Investigator: Sherwood Brown, MD, PhD, Professor

Completion Date (primary or actual): 2028-08

CT.gov Identifier: NCT07685964

Imaging the Neurochemistry of Drug Addiction With PET

The investigators' project has two overarching goals. 1) The investigators will use newly developed positron emission tomography (PET) technology to investigate the dopaminergic neurochemistry of drugs of abuse including marijuana, traditional cigarettes, and cocaine, and 2) The investigators will extend PET technology to an additional neurotransmitter system - namely, the opioid-ergic system, using the same drugs of abuse.

First Posted: 2016-06-29

Condition(s): Smoking, Cannabis

Intervention(s): cannabis

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: NA

Sponsor: Yale University

Principal Investigator: Kelly Cosgrove, Associate Professor

Completion Date (primary or actual): 2024-06-14

CT.gov Identifier: NCT02817698

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed. Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects. In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.

First Posted: 2014-01-31

Condition(s): Schizophrenia

Intervention(s): Cannabidiol CR, Cannabidiol, Amisulpride, Olanzapine, Quetiapine, Risperidone, Placebo

Status: COMPLETED

Enrollment (expected or actual): 74

Allocation: RANDOMIZED

Sponsor: Central Institute of Mental Health, Mannheim

Principal Investigator:

Completion Date (primary or actual): 2017-08

CT.gov Identifier: NCT02051387

Families With Substance Use and Psychosis: A Pilot Study

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.

First Posted: 2020-02-26

Condition(s): Psychosis, Substance Use, Substance Use Disorders, Family, Tobacco Use, Nicotine Use Disorder, Cigarette Smoking, Cannabis, Marijuana, Alcohol Use Disorder, Alcohol, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Mental Disorder

Intervention(s): CRAFT-FT

Status: COMPLETED

Enrollment (expected or actual): 29

Allocation: NA

Sponsor: Mclean Hospital

Principal Investigator: Julie McCarthy, Ph.D., Assistant Psychologist

Completion Date (primary or actual): 2022-07-07

CT.gov Identifier: NCT04284813

Influence of CBD on Episodic Memory in Healthy Subjects

Placebo controlled, randomized, double blind, cross-over design. Single vape of 0.25ml 5% CBD e-liquid (12.5mg CBD) and single vape of 0.25ml e-liquid, tastes like lemon and madeleine. 15min vape time each. A total of 34 participants, equal number of male and female. There will be replacement of Drop-Outs until data from 34 participants are completed. The primary endpoint will be performance in a verbal memory task. The secondary endpoint will be performance in a working memory test.

First Posted: 2018-08-13

Condition(s): Healthy

Intervention(s): Verum, Placebo

Status: COMPLETED

Enrollment (expected or actual): 39

Allocation: RANDOMIZED

Sponsor: Prof. Dominique de Quervain, MD

Principal Investigator: Prof. Dominique de Quervain, MD, Prof. Dr. med.

Completion Date (primary or actual): 2018-12-08

CT.gov Identifier: NCT03627117

Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).

First Posted: 2010-10-18

Condition(s): Muscle Spasticity as a Result of Spinal Cord Injury

Intervention(s): nabilone 0.5 mg, placebo

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: University of Manitoba

Principal Investigator: Dr. Karen Ethans, Principal Investigator MD

Completion Date (primary or actual): 2015-02

CT.gov Identifier: NCT01222468

Nutrition and Pharmacological Algorithm for Oncology Patients Study

Loss of appetite is a common symptom of patients with cancer and can cause distress which impacts patients and caregivers. Patients diagnosed with head/neck, lung or pancreatic cancer will be recruited for this study to decrease the suffering and distress associated with eating during cancer treatment and improve the quality of life of patients by implementing an algorithm utilizing nutrition intervention and appetite stimulants.

First Posted: 2019-11-07

Condition(s): Oncologic Complications, Quality of Life, Nutrition Poor, Head and Neck Cancer, Lung Cancer, Pancreatic Cancer

Intervention(s): Dexamethasone, Dronabinol, Mirtazapine, Nutrition Intervention

Status: TERMINATED

Enrollment (expected or actual): 1

Allocation: NON_RANDOMIZED

Sponsor: Montefiore Medical Center

Principal Investigator:

Completion Date (primary or actual): 2021-04-05

CT.gov Identifier: NCT04155008

THC Crossover Study

This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.

First Posted: 2020-06-12

Condition(s): THC, Cannabis, Cannabis Smoking, Cannabis Use, Unspecified, Cigarette Smoking, Tobacco Use, Nicotine Dependence, Nicotine Withdrawal, Cardiovascular Risk Factor

Intervention(s): Smoked Cannabis, Vaped Cannabis, Tobacco Cigarette

Status: COMPLETED

Enrollment (expected or actual): 14

Allocation: RANDOMIZED

Sponsor: University of California, San Francisco

Principal Investigator:

Completion Date (primary or actual): 2024-06-25

CT.gov Identifier: NCT04429568

Neurobiological Principles Applied to the Rehabilitation of Stroke Patients

The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to improve learning of movement skills and the adaptation processes in patients after stroke. Once investigators have determined the improving effect of TMS and the drugs on learning of movement skills, the study team may be able to provide information that improves rehabilitative treatment and helps to improve recovery after stroke.

First Posted: 2008-07-15

Condition(s): Stroke

Intervention(s): Transcranial Magnetic Stimulation (TMS), Carbidopa-Levodopa, Methylphenidate, Amphetamine Sulfate, Placebo, Sham Transcranial Magnetic Stimulation (TMS), Transcranial Magnetic Stimulation (TMS) Training

Status: COMPLETED

Enrollment (expected or actual): 33

Allocation: RANDOMIZED

Sponsor: Emory University

Principal Investigator: Cathrin Buetefisch, Dr. Cathrin Buetefisch

Completion Date (primary or actual): 2016-09

CT.gov Identifier: NCT00715520

Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of cannabigerol (CBG; CHI-914), a naturally occurring chemical constituent of the cannabis plant formulated for oral consumption, in healthy adults. The study will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design.Upon enrollment, participants will complete 5 oral dosing conditions (placebo, 25, 50, 100, and 200 mg CBG). Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic drug effects. This work will provide novel data on the pharmacokinetics, pharmacodynamic effects, and safety of acute oral CBG dose administration in humans.

First Posted: 2022-04-13

Condition(s): Behavioral Pharmacology of Cannabis

Intervention(s): Oral Placebo, Oral CBG Cannabis

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: University of Maryland, Baltimore

Principal Investigator:

Completion Date (primary or actual): 2025-08-15

CT.gov Identifier: NCT05324982

Honey & Nigella Sativa Trial Against COVID-19

To evaluate the effectiveness of Nigella Sativa and honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).

First Posted: 2020-04-15

Condition(s): Coronavirus Infection, Sars-CoV2

Intervention(s): Honey, Nigella Sativa / Black Cumin, Placebos

Status: COMPLETED

Enrollment (expected or actual): 313

Allocation: RANDOMIZED

Sponsor: Sohaib Ashraf

Principal Investigator: Sohaib Ashraf, Post-Graduate Resident Cardiology

Completion Date (primary or actual): 2020-08-30

CT.gov Identifier: NCT04347382

Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741. ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide. Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

First Posted: 2020-05-07

Condition(s): Parkinson's Disease (PD)

Intervention(s): ABBV-951

Status: COMPLETED

Enrollment (expected or actual): 130

Allocation: NA

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2026-04-17

CT.gov Identifier: NCT04379050

Perceptions of Proposed Warnings for Cannabis Edibles Packaging

The purpose of this study is to compare a delayed-effects warning to an expanded warning developed in previous experiments on knowledge, harm perceptions, and willingness to try cannabis edibles. Additionally, this study will examine the effects of a corresponding icon on attention to and recall of the warning.

First Posted: 2026-03-27

Condition(s): Cannabis Use

Intervention(s): No Warning Control, Delayed Effects Text Only, Delayed Effects Plus Icon, Delayed Effects Plus Dose, Delayed Effects Plus Dose Plus Adverse Effects

Status: COMPLETED

Enrollment (expected or actual): 1250

Allocation: RANDOMIZED

Sponsor: Wake Forest University Health Sciences

Principal Investigator:

Completion Date (primary or actual): 2026-07-21

CT.gov Identifier: NCT07496489

Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic back pain disorders. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic back pain.

First Posted: 2023-10-10

Condition(s): Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Back Pain, Lower Back Pain, Lower Back Pain Chronic

Intervention(s): Adezunap (AP707), Placebo

Status: UNKNOWN

Enrollment (expected or actual): 558

Allocation: RANDOMIZED

Sponsor: Apurano Pharmaceuticals GmbH

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT06072560

Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults

The goal of this observational study is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol (CBG) in healthy human adults age 21 or over. The main questions it aims to answer are: * What effect, if any, does daily oral consumption of 50mg of full spectrum CBG have on the mental, physical, and emotional wellbeing of healthy individuals, as measured by self-report Medical Symptom Questionnaire and 36-Item Short Form Health Survey scores? * Is CBG effective at reducing inflammation in the body, as measured by HSCRP, ESR, and PSA inflammatory markers? * Do age, gender, weight, or state of body inflammation have an effect on the perceived efficacy of CBG? * What adverse effects, if any, are associated with CBG use? Over the course of the 12-week study, participants will: * Take baseline MSQ and SF-36 surveys, as well as a clinical visit with blood draws for HSCRP, ESR, and PSA testing * Consume one (1) 50mg capsule of full spectrum CBG daily by mouth with food for 8 weeks, followed by a 4-week washout period * Complete biweekly SF-36 surveys as well as MSQ surveys every 4 weeks * Attend a clinical visit every 4 weeks for clinical observation and blood draws for HSCRP, ESR, and PSA (male subjects)

First Posted: 2023-02-24

Condition(s): Health, Subjective, Inflammatory Response, Adverse Effect, Side Effect

Intervention(s): Cannabigerol

Status: COMPLETED

Enrollment (expected or actual): 69

Allocation: NA

Sponsor: Formula30A LLC

Principal Investigator:

Completion Date (primary or actual): 2024-04-30

CT.gov Identifier: NCT05743985

Probing the Cannabinoid System in Individuals With a Family History of Psychosis

The overall purpose of this study is to determine whether a family history of psychosis is associated with an altered cannabinoid system. This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that compared to controls with no family history of psychoses, individuals with a family history of psychoses will have an altered response to THC.

First Posted: 2014-04-02

Condition(s): Psychosis, Cannabis Use, THC, Marijuana, Schizophrenia

Intervention(s): Placebo, Very Low Dose THC, Low Dose THC

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 21

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT02102113

Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia

This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).

First Posted: 2019-08-30

Condition(s): Alzheimer Disease, Anxiety, Agitation,Psychomotor, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Intervention(s): high CBD/low THC sublingual solution

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 12

Allocation: NA

Sponsor: Mclean Hospital

Principal Investigator: Staci Gruber, Ph.D., Directory, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery (MIND)

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT04075435

Cannabinoids, Learning, and Memory

The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

First Posted: 2015-04-03

Condition(s): Cannabis, Psychotic Disorders

Intervention(s): THC, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, Associate Professor

Completion Date (primary or actual): 2027-12

CT.gov Identifier: NCT02407808

The Effect of Cannabis on Dementia Related Agitation and Aggression

The most common syndrome in patients with severe dementia is agitated behavior, which is often characterized by a combination of violent behavior (physical or verbal), restlessness, and inappropriate loudness. The treatment options for this syndrome are limited and lead to severe side effects. In vivo experiments on animals and clinical studies on adults show that cannabinoids could have a beneficial effect on behavioral disorders in general, and in dementia-related disorders in particular. Additionally, medical cannabis patients have reported that cannabis aids in pain relief, increased appetite, and a sense of calm and peace of mind. Elderly patients suffering from dementia that experience this syndrome could also benefit from other quality of life aspects of the cannabis treatment such as reduction in medication consumption, weight gain and improvement of sleep.

First Posted: 2017-11-01

Condition(s): Agitation Related to Dementia

Intervention(s): Cannabis, Placebo oil

Status: COMPLETED

Enrollment (expected or actual): 64

Allocation: RANDOMIZED

Sponsor: TO Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2019-08-18

CT.gov Identifier: NCT03328676

Human CNS Tau Kinetics in Tauopathies

The goal of this study is to characterize tau kinetics and tau aggregation in the human CNS and to test the hypothesis that tau kinetics are altered (i.e. increased production, decreased clearance, and increased aggregation rate) in tauopathies.

First Posted: 2018-06-04

Condition(s): Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD), Frontotemporal Dementia (FTD MAPT Mutation)

Intervention(s): 13C6 Leucine

Status: COMPLETED

Enrollment (expected or actual): 27

Allocation:

Sponsor: Washington University School of Medicine

Principal Investigator:

Completion Date (primary or actual): 2022-03-04

CT.gov Identifier: NCT03545126

The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

In this retrospective study, the investigators evaluate the relationship of post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.

First Posted: 2020-01-21

Condition(s): Cholecystitis

Intervention(s): ERCP

Status: COMPLETED

Enrollment (expected or actual): 1117

Allocation:

Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Principal Investigator: Wenbo Meng, M.D., Ph. D, Director of surgery

Completion Date (primary or actual): 2021-11-18

CT.gov Identifier: NCT04234126

Reducing the Harmful Effects of Cannabis Use: Finding the Optimal CBD:THC Ratio

This study will recruit healthy volunteers who use cannabis infrequently. Each participant will attend the laboratory on five occasions: an initial visit to check that they are safe to join the study and four days of testing. Participants will be administered, in a randomized order, vaporized cannabis containing one of four different ratios of CBD:THC (0:1, 1:1, 2:1, 3:1). The cannabis administration will follow a standardised inhalation procedure using a medical-grade vaporizer device. Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences. The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.

First Posted: 2021-12-27

Condition(s): Cannabis Use

Intervention(s): THC, Cannabidiol, Cannabidiol, Cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 46

Allocation: RANDOMIZED

Sponsor: King's College London

Principal Investigator:

Completion Date (primary or actual): 2019-06-09

CT.gov Identifier: NCT05170217

MiREA-AC for Reducing Problematic Alcohol and Marijuana Use in College Students

The goal of this STTR Phase I funded study is to address the urgent need for an effective primary prevention approach to the problem of heavy episodic drinking and cannabis misuse among mandated college students. Smartphone app interventions are expanding and can offer accessible, scalable, and cost-effective tools. The study will be used to attune a successful evidence-based mHealth smartphone (SP) application (MiREA-AC) focused on alcohol and Cannabis misuse by college students with enhanced content to promote health-seeking behaviors. To test and disseminate the adapted prototype (MiREA-AC), a multisite pilot trial will be conducted to obtain data on the intervention's usability and feasibility in modifying alcohol and cannabis use.

First Posted: 2026-01-14

Condition(s): Alcohol Misuse, Cannabis Misuse

Intervention(s): Motivational Intervention Reduction through Ecological Application (MiREA-A). MiREA-AC-- the expanded MiREA-A,

Status: RECRUITING

Enrollment (expected or actual): 150

Allocation: NA

Sponsor: mHealth Systems Inc.

Principal Investigator:

Completion Date (primary or actual): 2026-04-30

CT.gov Identifier: NCT07339150

Efficacy of Dronabinol for the Treatment of Cervical Dystonia

Cervical dystonia (CD) is characterized by abnormal, involuntary sustained cervical muscles contractions associated with twisting movements and abnormal postures of the neck that can be quite disabling. Currently there are no good oral medications for the treatment of CD. While botulinum toxin injections are effective in most, they require repeat injections and there are some patients who either stop responding or who never respond at all. Therefore, better treatments are needed. While the underlying mechanisms of dystonia are not entirely known, there is some information suggesting that it is ude to an underactivity of a chemical compound, GABA, that is located in the basal ganglia. Cannabinoids are a compound than can enhance transmission of GABA, and thus, may alleviate the symptoms of dystonia. Dronabinol, one such cannabinoid, has been widely used to treat anorexia and nausea in chemotherapeutic patients. The aim of this study, therefore, is to study the effect of dronabinol on cervical dystonia

First Posted: 2007-01-05

Condition(s): Cervical Dystonia

Intervention(s): Dronabinol

Status: UNKNOWN

Enrollment (expected or actual): 38

Allocation: RANDOMIZED

Sponsor: University Health Network, Toronto

Principal Investigator:

Completion Date (primary or actual): 2009-12

CT.gov Identifier: NCT00418925

Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use Cigarettes, E-cigarettes and Cannabis (Co-Tox Study)

This study evaluates the amount of nicotine, cannabis, and toxicants linked to the use of nicotine e-cigarette and/or cannabis products in the blood and urine of young adult users as well as the cannabis and nicotine use behaviors of consumers.

First Posted: 2025-09-11

Condition(s): Cigarette Smoking-Related Carcinoma, E-Cig Use

Intervention(s): Effectiveness of different recruitment approaches, Choice of study completion locations, Cannabis Engagement Assessment, E-cigarette dependence Scale, Nicotine dependence Scale, Co use practices QUestionnaire

Status: RECRUITING

Enrollment (expected or actual): 150

Allocation:

Sponsor: Roswell Park Cancer Institute

Principal Investigator:

Completion Date (primary or actual): 2028-10-01

CT.gov Identifier: NCT07167225

A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin

To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.

First Posted: 2012-05-25

Condition(s): Pain, Multiple Sclerosis

Intervention(s): GW-1000-02, Placebo

Status: COMPLETED

Enrollment (expected or actual): 70

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2002-08

CT.gov Identifier: NCT01606176

Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents With Cannabis Use Disorder

This project seeks to learn more about the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents to address a fundamental gap in knowledge and identify biomarkers that may help distinguish youth who relapse from youth who remain sober.

First Posted: 2022-05-31

Condition(s): Cannabis Use

Intervention(s): Contingency Management

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 30

Allocation: NA

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT05396638

Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake

The purpose of this study is to examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.

First Posted: 2014-12-08

Condition(s): Appetite Regulation

Intervention(s): dronabinol, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 18

Allocation: RANDOMIZED

Sponsor: Universitaire Ziekenhuizen KU Leuven

Principal Investigator:

Completion Date (primary or actual): 2025-10

CT.gov Identifier: NCT02310347

High Confusion: Cannabis & Driving

This study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.

First Posted: 2024-02-01

Condition(s): Impairment, Cognitive, Impairment of Attention, Impairment, Psychomotor

Intervention(s): Delta-9-THC, Delta-8-THC, Placebo

Status: COMPLETED

Enrollment (expected or actual): 5

Allocation: RANDOMIZED

Sponsor: University of Wisconsin, Madison

Principal Investigator:

Completion Date (primary or actual): 2025-09-16

CT.gov Identifier: NCT06236815

Cannabidiol for Alcohol Use Disorder

The purpose of this study is to determine whether cannabidiol, relative to placebo, affects subjective response to alcohol or alcohol drinking.

First Posted: 2019-04-05

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator:

Completion Date (primary or actual): 2020-04-30

CT.gov Identifier: NCT03904849

A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients

A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.

First Posted: 2010-10-27

Condition(s): Parkinson's Disease

Intervention(s): Saline, Carbidopa

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: NeuroDerm Ltd.

Principal Investigator:

Completion Date (primary or actual): 2011-11

CT.gov Identifier: NCT01229332

Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome

The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS). The secondary objectives of this study are to assess the efficacy, safety and tolerability, impact on quality of life, and impact on physical activity of cannabidiol oral solution in patients with PWS.

First Posted: 2016-07-26

Condition(s): Prader-Willi Syndrome

Intervention(s): Cannabidiol, Placebo

Status: TERMINATED

Enrollment (expected or actual): 7

Allocation: RANDOMIZED

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): 2019-07-31

CT.gov Identifier: NCT02844933

An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications

This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.

First Posted: 2014-03-10

Condition(s): Advanced Parkinson's Disease

Intervention(s): ABT-SLV187

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: NA

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2019-10-31

CT.gov Identifier: NCT02082249

Efficacy and Safety of Surgical Treatment for Type IVa CBD

This study is a multicenter, bidirectional cohort study aimed at continuously enrolling patients with biliary dilatation from 25 medical centers in China. It will collect comprehensive life-cycle data from the cohort to establish a Chinese cohort for IVa biliary dilatation (BD). Based on this cohort, the study seeks to compare the perioperative risks, long-term outcomes, and quality of life of type IVa BD following surgical treatment, to establish standardized surgical treatment strategies for type IVa BD.

First Posted: 2025-06-25

Condition(s): Choledochal Cyst

Intervention(s):

Status: RECRUITING

Enrollment (expected or actual): 1500

Allocation:

Sponsor: Beijing Tsinghua Chang Gung Hospital

Principal Investigator: Shuo Jin, Associate Chief Physician

Completion Date (primary or actual): 2035-07-01

CT.gov Identifier: NCT07036848

The Biological Effect of ESWT and the Role of Proinflammatory Cytokines and Cannabinoid Receptor in Shoulder Stiffness

Investigators recent data showed anti-inflammatory effect of Effect of Extracorporeal Shockwave Technology (ESWT). Little studies focused on the effect and pathomechanism of ESWT on shoulder stiffness.

First Posted: 2015-05-21

Condition(s): Stiffness of Shoulder, Not Elsewhere Classified

Intervention(s): ESWT

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Chang Gung Memorial Hospital

Principal Investigator:

Completion Date (primary or actual): 2019-07-31

CT.gov Identifier: NCT02450864

Cannabidiol and Older Adult Cannabis Users

Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

First Posted: 2024-03-04

Condition(s): Sleep, Anxiety, Depression, Pain

Intervention(s): fsCBD Cannabidiol, bsCBD Cannabidiol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 385

Allocation: RANDOMIZED

Sponsor: University of Colorado, Boulder

Principal Investigator: Angela Bryan, Professor

Completion Date (primary or actual): 2028-08-31

CT.gov Identifier: NCT06290063

Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies

EudraCT: 2018-003887-29 Objective:To evaluate the safety and efficacy of: MGCND00EP1 from MGC PHARMACEUTICALS d.o.o. Study Design: Randomized, double blind, placebo controlled parallel grouped study Sample Size: 103 subjects Study Population: Children from 1 year to 18 years of age Comparator Product :Placebo solution, oral IMP Product : MGCND00EP1 (each ml of solution containing 100 mg of cannabidiol and 5 mg of (-)-trans-Δ9- tetrahydrocannabinol as active substance) from MGC PHARMACEUTICALS D.O.O. According to dosing scheme up to 25 mg/kg BW per day or maximum daily dose 800 mg (whichever smaller) for 6 weeks titration and 6 weeks of treatment, oral administration

First Posted: 2020-05-29

Condition(s): Resistant Epilepsy, Drug, Adolescent Epilepsy, Children Epilepsy, Children and Adolescents With Resistant Epilepsies

Intervention(s): MGCND00EP1, Placebo, ECG, EEG, Blood and urine collection

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: MGC Pharmaceuticals d.o.o

Principal Investigator:

Completion Date (primary or actual): 2024-05-30

CT.gov Identifier: NCT04406948

Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network

The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC).

First Posted: 2011-10-18

Condition(s): Substance Use

Intervention(s): iSBIRT

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Boston Children's Hospital

Principal Investigator: John R Knight, MD, Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Completion Date (primary or actual): 2016-12

CT.gov Identifier: NCT01454206

Cannabidiol and Alcohol Use Disorder Phenotypes

The goal of this study is to learn how CBD affects drinking in people who drink alcohol regularly. Researchers want to see if CBD can help people drink less and reduce problems related to alcohol use.

First Posted: 2025-12-12

Condition(s): Alcohol Use Disorder

Intervention(s): Full-Spectrum Cannabidiol (CBD), Broad-Spectrum Cannabidiol (CBD), Placebo

Status: RECRUITING

Enrollment (expected or actual): 150

Allocation: RANDOMIZED

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2029-08-31

CT.gov Identifier: NCT07279558

A TQT Study to Evaluate the Electrocardiographic Effects of Carbidopa in Healthy Subjects

The purpose of this trial is to assess the effects of a single supratherapeutic dose of carbidopa on cardiac repolarization relative to placebo in healthy adult subjects.

First Posted: 2023-12-07

Condition(s): Cardiac Repolarization in Healthy Subjects

Intervention(s): Carbidopa capsule, Moxifloxacin Tablets, USP, Placebo

Status: COMPLETED

Enrollment (expected or actual): 35

Allocation: RANDOMIZED

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): 2023-12-05

CT.gov Identifier: NCT06161220

A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease

The primary objective of this study is to evaluate change in non-motor symptoms from baseline to Week 12 as measured by the Non-Motor Symptom Scale total score.

First Posted: 2012-11-29

Condition(s): Advanced Parkinson's Disease

Intervention(s): Levodopa-Carbidopa Intestinal Gel, Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J), Levodopa-carbidopa Immediate Release (LC-IR) Tablets

Status: COMPLETED

Enrollment (expected or actual): 39

Allocation: NA

Sponsor: AbbVie (prior sponsor, Abbott)

Principal Investigator:

Completion Date (primary or actual): 2015-12

CT.gov Identifier: NCT01736176

Approach Bias Modification for the Treatment of Cannabis Use Disorder

Effective and durable treatments for cannabis use disorder remain elusive. Given the increasing prevalence rates of cannabis use and CUD nationwide, investigation of novel treatments is warranted. Implicit cognitive processing is an emerging, and potentially critical therapeutic target. Cognitive models of addiction posit an override of explicit control-related cognitive processes by implicit reward-driven processes resulting from chronic drug exposure. One form of implicit cognitive processing is approach bias, or, the automatic tendency to approach rather than avoid drug cues, which has been identified for alcohol, nicotine, opioids, and cannabis. Cannabis approach bias predicts increased cannabis use, dependence severity, and cannabis-related problems among heavy cannabis users. Approach bias modification (ABM) is a novel treatment approach that seeks to reduce approach bias by attenuating the incentive-salience of drug cues, and subsequently, drug cue reactivity and drug use. ABM has been shown to reduce relapse rates in alcohol dependent adults by 10-13% at one-year follow-up, and dependence severity in nicotine dependent adults. Our pilot data suggests that ABM may also reduce cannabis craving and that gender may moderate the effect of ABM on cannabis sessions per day in non-treatment seeking adults with CUD. A recent fMRI study with alcohol-dependent adults found decreased mesolimbic activation in participants who received ABM compared to sham-control participants. ABM appears to target implicit reward-driven processes, and could be an effective adjunct to traditional psychosocial and/or future pharmacological interventions that target explicit control-related processes. Building on our promising feasibility data, the proposed K23 research study will examine the effects of ABM on cue-reactivity and cannabis outcomes in a four-session randomized, double-blind, sham-controlled pilot treatment trial. One-hundred and six (106) treatment-seeking adults with moderate to severe CUD will be randomized to receive either MET/CBT plus ABM or Motivational Enhancement Therapy/Cognitive Behavioral Therapy(MET/CBT) plus sham-ABM. An equal number of men and women will be recruited and randomization will be stratified by gender. ABM sessions will occur following each of the three weekly MET/CBT therapy sessions. Primary outcomes will include cannabis cue-reactivity and cannabis use.

First Posted: 2018-08-14

Condition(s): Cannabis Use Disorder

Intervention(s): Approach Bias Modification (ABM), Sham ABM, Psychosocial therapy for cannabis use disorder.

Status: COMPLETED

Enrollment (expected or actual): 104

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator:

Completion Date (primary or actual): 2023-10-30

CT.gov Identifier: NCT03629990

Comparison of FNB to EUS-CNB for Pancreatic Lesions

The primary aim of this study is to compare the tissue specimen quality and diagnostic accuracy of biopsies obtained with one puncture of a regular 22 FNB G needle and the motorized EUS CNB device of pancreatic lesions. The secondary aims are to compare the rate of blood contamination in the specimens obtained from biopsies of pancreatic lesions and the overall procedure duration. The hypothesis of this study is that the proportion of cases in which a single puncture of the lesion in question delivers adequate diagnostic tissue is higher with the motorized EUS CNB than with the 22 G FNB.

First Posted: 2025-11-21

Condition(s): Diagnosis of a Pancreaticobiliary Disorder, Biopsy, EUS Guided Biopsy

Intervention(s): endoscopic ultrasound guided biopsy with core needle biopsy device, EUS-FNB

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: University of California, Davis

Principal Investigator:

Completion Date (primary or actual): 2026-11-01

CT.gov Identifier: NCT07240818

Peer Approaches to Substances in Early Psychosis Programs: A Pilot Study of a Peer-Led Intervention

The aim of the study is to pilot a peer-provided, manualized intervention to increase the proportion of young people with first episode psychosis who reduce or stop substance use and improve psychiatric and functional outcomes. Coordinated specialty care teams will be randomly assigned to implement the intervention, Peer Approaches to Substances in Early Psychosis Programs (PAS-EPP), or usual care. The pilot study aims to: (a) determine if peer providers can implement PAS-EPP with adequate fidelity; (b) determine if youth and young adults engage in the intervention with peer providers and find it acceptable; (c) estimate the rates of drop-out for each of the two study arms; (d) estimate both between-participant (within-provider team) and between-team variability on key outcome measures; and (e) identify any changes needed to the intervention approach, manual, or training materials. The pilot study will set the stage for a future comparative cluster randomized trial of the intervention;

First Posted: 2020-08-18

Condition(s): Psychotic Disorders, Substance Use

Intervention(s): Peer Approach to Substances in Early Psychosis Programs, Usual Care Peer Services

Status: COMPLETED

Enrollment (expected or actual): 113

Allocation: RANDOMIZED

Sponsor: University of Texas at Austin

Principal Investigator: Molly Lopez, Research Associate Professor

Completion Date (primary or actual): 2025-07-25

CT.gov Identifier: NCT04517279

Impact of Daily Oral Cannabis Doses in Patients With Cancer

This study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months. There is a 3/4 (or 75%) chance that a participant will receive an active cannabis dose in the study. There is a 1/4 (or 25% chance) that a participant will receive a placebo dose (meaning a blank dose/no cannabis/no active drug). The goals of this study are to determine 1) the safety and tolerability of cannabis in individuals with cancer and 2) if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting, appetite, pain, sleep, and quality of life.

First Posted: 2024-09-19

Condition(s): Cancer, Cancers, Pain

Intervention(s): Oral cannabis low THC, Placebo Comparator, Oral cannabis high THC, Oral cannabis THC/CBD

Status: RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Shanna Babalonis, PhD

Principal Investigator: Shanna Babalonis, PhD, Associate Professor, College of Medicine

Completion Date (primary or actual): 2030-12-01

CT.gov Identifier: NCT06601218

A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years

A study to assess the effects of Sativex treatment on spasticity in a population of children and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous system injury. Efficacy (ability to improve symptoms), safety and tolerability will be monitored.

First Posted: 2013-07-12

Condition(s): Cerebral Palsy

Intervention(s): Sativex, Placebo

Status: COMPLETED

Enrollment (expected or actual): 72

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2017-03

CT.gov Identifier: NCT01898520

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Oral submucous fibrosis (OSMF) is a potentially malignant condition mainly characterized by inflammation and fibrosis of the submucosal tissues leading to marked rigidity and reduced opening of the jaws. OSMF has a multifactorial etiology but areca nut consumption is considered to be the most consistent factor in its pathogenesis. There is no definitive treatment available for treating OSMF. Conventional management involves physiotherapy exercises and treating the disease with certain medications such as steroids and homeopathic medications.

First Posted: 2020-07-20

Condition(s): Oral Submucous Fibrosis

Intervention(s): Nigella sativa oil, Betamethasone Valerate

Status: COMPLETED

Enrollment (expected or actual): 39

Allocation: RANDOMIZED

Sponsor: Ziauddin University

Principal Investigator: Hira Batool, Doctor

Completion Date (primary or actual): 2021-09-30

CT.gov Identifier: NCT04476420

Emerging Adults Who Use Alcohol and Marijuana

The purpose of this study is to if a brief motivational intervention, compared to health education sessions, reduces alcohol and marijuana use and is related to fewer sexually transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.

First Posted: 2011-11-17

Condition(s): Alcohol Use, Marijuana Use, Sexually Transmitted Infections

Intervention(s): motivational intervention, health education

Status: COMPLETED

Enrollment (expected or actual): 566

Allocation: RANDOMIZED

Sponsor: Butler Hospital

Principal Investigator: Michael Stein, MD, Principal Investigator

Completion Date (primary or actual): 2017-08

CT.gov Identifier: NCT01473719

Dietary Carbohydrate Consumption on Memory Performance and Mood in Children

The purpose of this study is to determine the effect of carbohydrates on blood glucose levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight (NW) and overweight or obese (OW/OB) children.

First Posted: 2016-07-01

Condition(s): Cognitive Ability, General

Intervention(s): Meal Skipping, French fries, Mashed potatoes, Hash browns, Rice, Beans

Status: COMPLETED

Enrollment (expected or actual): 22

Allocation: RANDOMIZED

Sponsor: Toronto Metropolitan University

Principal Investigator: Nick Bellissimo, Associate Professor, School of Nutrition

Completion Date (primary or actual): 2016-10

CT.gov Identifier: NCT02820805

Does Consuming Modified Plant Seed Oil Containing Fish Oil Fatty Acids Act in the Same Way as Consuming Fish Oil?

Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be beneficial to health. Many people consume little, despite UK government recommendations to eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish stocks are declining due to over fishing. Therefore, there is a need for an alternative, sustainable and cost efficiently produced dietary source. A seed oil source of these fish oil-type fatty acids has been achieved by adding genes from other plant sources to the oil seed plant Camelina sativa. Camelina sativa, related to mustard and cabbage, has provided seed oil for human consumption for thousands of years. It was the most important oil seed plant in Europe until the 1900's. This research is being done to see if consuming fish oil-type fatty acids in Camelina seed oil allows the body to take up and use the fish oil fatty acids in the same way as it does from fish oil.

First Posted: 2018-03-26

Condition(s): Healthy

Intervention(s): Single dose fish oil, Repeated dose fish oil, single dose Camelina seed oil, repeated dose camelina seed oil

Status: COMPLETED

Enrollment (expected or actual): 31

Allocation: RANDOMIZED

Sponsor: University of Southampton

Principal Investigator:

Completion Date (primary or actual): 2019-11-04

CT.gov Identifier: NCT03477045

Lithium Cannabis Withdrawal Study

This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.

First Posted: 2005-06-15

Condition(s): Cannabis Dependence, Substance Withdrawal Syndrome

Intervention(s): Lithium carbonate

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: NON_RANDOMIZED

Sponsor: Sydney South West Area Health Service

Principal Investigator:

Completion Date (primary or actual): 2006-09

CT.gov Identifier: NCT00114439

Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

This project aims to develop and test an intervention for the simultaneous treatment of cannabis use disorders and tobacco smoking. This is important because over 50% of adults seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases their chance for a successful treatment outcome and increases adverse acute and long-term psychosocial and health consequences. The proposed treatment will integrate existing computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement medications to improve outcomes in this difficult to treat clinical population.

First Posted: 2013-04-18

Condition(s): Cannabis Dependence

Intervention(s): MET/CBT/CM plus NRT

Status: COMPLETED

Enrollment (expected or actual): 33

Allocation: NA

Sponsor: Dartmouth-Hitchcock Medical Center

Principal Investigator: Alan J. Budney, Professor

Completion Date (primary or actual): 2015-01

CT.gov Identifier: NCT01834794

Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma

The goal of this proposal is to determine how cannabinoid use affects the tumor immune microenvironment (TME) of melanoma by correlating TILs with reported cannabinoid use and circulating plasma cannabinoids. The central hypothesis is that cannabinoid use decreases TILs in melanoma in a dose-dependent fashion. This is important because cannabinoid-driven TME changes in melanoma may alter patient outcomes mediated by TILs and response to standard of care ICI treatments.

First Posted: 2022-08-29

Condition(s): Melanoma

Intervention(s): High-performance liquid chromatography-tandem mass spectrometry assays

Status: UNKNOWN

Enrollment (expected or actual): 90

Allocation:

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2024-08-31

CT.gov Identifier: NCT05520294

Effects of CBD on 2 Mile Run Time Trial Performance

Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female.

First Posted: 2024-04-15

Condition(s): Healthy

Intervention(s): Cannabidiol Capsules

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: University of Northern Colorado

Principal Investigator: Laura Stewart, Professor

Completion Date (primary or actual): 2024-05-30

CT.gov Identifier: NCT06364254

Use of CBD in the Treatment of Anxiety

This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.

First Posted: 2024-11-04

Condition(s): Anxiety, Generalized Anxiety Disorder, Sleep Problems

Intervention(s): Hemp Derived Cannabidiol Extract, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): 2026-12-31

CT.gov Identifier: NCT06672666

Longitudinal Study of Xenon-129 MRI Imaging Effects of Cannabis Smoking

This is a longitudinal study of the long-term health impact of cannabis smoking on the lungs. Participants will be followed over a period of 3 years, and impacts of cannabis smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.

First Posted: 2019-04-10

Condition(s): Cannabis Use, Cannabis Smoking, Marijuana Smoking, Marijuana Usage

Intervention(s): Hyperpolarized Xenon-129 MRI of the lungs, Computed Tomography (CT), Pulmonary Function Tests (PFTs), Six Minute Walk Test (6MWT), Cardiopulmonary exercise testing (CPET), Sputum analysis, Blood analysis

Status: RECRUITING

Enrollment (expected or actual): 200

Allocation:

Sponsor: Western University, Canada

Principal Investigator:

Completion Date (primary or actual): 2030-12-01

CT.gov Identifier: NCT03909477

Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions

This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.

First Posted: 2020-01-27

Condition(s): Coronary Artery Disease

Intervention(s): Drug-coating balloon

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 784

Allocation: RANDOMIZED

Sponsor: Nanjing First Hospital, Nanjing Medical University

Principal Investigator: Shaoliang Chen, MD, Vice President

Completion Date (primary or actual): 2026-06-30

CT.gov Identifier: NCT04242134

A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.

First Posted: 2015-09-15

Condition(s): Advanced Parkinson's Disease

Intervention(s): Optimized Medical Treatment, Levodopa-Carbidopa Intestinal Gel, Nasojejunal (NJ) tube, Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Status: COMPLETED

Enrollment (expected or actual): 89

Allocation: RANDOMIZED

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2022-11-18

CT.gov Identifier: NCT02549092

Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to traumatic or post-operative peripheral neuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to traumatic or post-operative peripheral neuropathy.

First Posted: 2023-10-10

Condition(s): Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Neuropathic Pain, Peripheral Neuropathy, Peripheral Neuralgia, Peripheral Nerve Injury, Post Operative Pain, Post-Traumatic Neuralgia, Plexopathy

Intervention(s): Adezunap (AP707), Placebo

Status: UNKNOWN

Enrollment (expected or actual): 558

Allocation: RANDOMIZED

Sponsor: Apurano Pharmaceuticals GmbH

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT06071936

Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.

First Posted: 2005-09-15

Condition(s): Parkinson Disease

Intervention(s): cabergoline, controlled-release levodopa / carbidopa

Status: TERMINATED

Enrollment (expected or actual): 220

Allocation: RANDOMIZED

Sponsor: Pfizer

Principal Investigator:

Completion Date (primary or actual): 2005-09

CT.gov Identifier: NCT00174239

IDUS in CBD Stone Recurrence High Risk Patients

This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP. Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy. Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded. Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.

First Posted: 2024-02-20

Condition(s): Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Ultrasonography

Intervention(s): IDUS examination

Status: COMPLETED

Enrollment (expected or actual): 248

Allocation: RANDOMIZED

Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Principal Investigator: Zhao Hang, Director of Department of Gastroenterology

Completion Date (primary or actual): 2026-04-16

CT.gov Identifier: NCT06265311

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

First Posted: 2007-09-17

Condition(s): Palliative Care, Pain, Cancer

Intervention(s): Sativex Low Dose, Sativex Medium Dose, Sativex High Dose

Status: COMPLETED

Enrollment (expected or actual): 360

Allocation: RANDOMIZED

Sponsor: GW Pharmaceuticals Ltd

Principal Investigator:

Completion Date (primary or actual): 2010-01

CT.gov Identifier: NCT00530764

GI Medical Cannabis Study on IBD

Create a registry that will described the natural history and landscape of medical cannabis product use in patients with chronic abdominal pain or inflammatory bowel disease. Quantitatively describe the pharmacokinetic (PK) profile of select medical cannabis products in patients with chronic neuropathic (abdominal) pain or inflammatory bowel disease. To create an educational program for families that have participated in the research for those families who opt for this component. Although these are not research in nature, they are a direct result of the proposed research and are included in the protocol to demonstrate the study's deliverables.

First Posted: 2019-03-22

Condition(s): Inflammatory Bowel Diseases, Neuropathic Pain

Intervention(s): Medical Marijuana

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation:

Sponsor: Children's Hospital of Philadelphia

Principal Investigator:

Completion Date (primary or actual): 2020-12-31

CT.gov Identifier: NCT03886532

Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development

The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\'s brain-related development during the first 3 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child\'s brain responses to sound at 4 weeks corrected age and infant behaviors at 3 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development.

First Posted: 2024-04-23

Condition(s): Child Development, Cannabis Use

Intervention(s): Placebo, Choline

Status: RECRUITING

Enrollment (expected or actual): 140

Allocation: RANDOMIZED

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2029-04-30

CT.gov Identifier: NCT06379971

Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.

First Posted: 2020-06-22

Condition(s): Parkinson Disease

Intervention(s): Multiple sleep latency tests

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation:

Sponsor: Central Hospital, Nancy, France

Principal Investigator:

Completion Date (primary or actual): 2023-06

CT.gov Identifier: NCT04441697

Gabapentin for Bipolar & Cannabis Use Disorders

The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with CUD+BD.

First Posted: 2017-11-07

Condition(s): Bipolar I Disorder, Bipolar II Disorder, Cannabis Use Disorder, Substance Use Disorders

Intervention(s): Gabapentin, Placebo Oral Capsule

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: James J. Prisciandaro, Assistant Professor

Completion Date (primary or actual): 2019-07-01

CT.gov Identifier: NCT03334721

Experimental Medicine in ADHD - Cannabinoids

Adult patients with ADHD commonly report an improvement in behavioural symptoms when using cannabis with some reporting a preference towards cannabis over their ADHD stimulant medication. The EMA-C study aims to investigate the effects of a cannabis based medication, Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD. This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in improvements in behaviour and cognition above that of the placebo group.

First Posted: 2014-09-25

Condition(s): Attention Deficit Hyperactivity Disorder (ADHD)

Intervention(s): Sativex Oromucosal Spray, Placebo

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: King's College London

Principal Investigator:

Completion Date (primary or actual): 2015-12

CT.gov Identifier: NCT02249299

Extension, Carbidopa-levodopa in Neovascular Age-related Macular Degeneration (AMD)

This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will use the two higher dose regimens of protocol 0002. these will be assigned according to how well the higher dose was tolerated in protocol 0002.

First Posted: 2017-06-23

Condition(s): Macula; Degeneration, Retina

Intervention(s): carbidopa-levodopa 25-100 mg

Status: COMPLETED

Enrollment (expected or actual): 35

Allocation: NA

Sponsor: Snyder, Robert W., M.D., Ph.D., P.C.

Principal Investigator:

Completion Date (primary or actual): 2020-07-09

CT.gov Identifier: NCT03197493

Reactions of Older Adults Driving After Cannabis Exposure

Objective of the Protocol: The primary aim of the current protocol is to examine whether or not habitual use of medical marijuana affects psychomotor functioning operationalized as driving performance. Secondary endpoints will examine whether type of medical marijuana used, frequency, dosage or route of administration is associated with Unwanted effects. The proposed study is a prospective repeated measures experimental study designed to test medical marijuana use as the exposure variable in adults age 50 and older and driving errors in response time, attention, and executive functions as the primary outcome. Secondary outcomes include: Unwanted effects. Participants will complete 3 assessments over a 3 month time period. The 3 assessment time points are: baseline (T1), prior to starting medical marijuana, 1 month post-medical marijuana initiation (T2), and 3 months post-medical marijuana initiation (T3). Electronic Medical Review (EMR) will be conducted at baseline, 1, and 3 months. In addition, potentially confounding disease, treatment, and sociodemographic characteristics will be examined. Data will be collected in a manner that is consistent with transparent reporting as mandated by CONSORT guidelines. Finite mixture modeling and generalized linear modeling accounting for individual and group level outcomes will be used to test the study hypotheses. The investigators propose to enroll 60 adults (n=30 medical marijuana users and n=30 age, race, sex matched controls) ages 50 and older with chronic/severe non-malignant pain, which is the most common diagnosis for medical marijuana users. Primary Endpoint: Thus, the proposed study will test medical marijuana use as the exposure variable in adults age 50 and older and simulated driving performance (e.g. errors in response time, attention, and executive functioning tasks that predict on-road performance) as the primary outcome. Secondary Endpoint: Further, the investigators will explore the association between medical marijuana use and Unwanted effects.

First Posted: 2020-11-16

Condition(s): Chronic Pain

Intervention(s): Medical Cannabis

Status: COMPLETED

Enrollment (expected or actual): 44

Allocation:

Sponsor: Florida State University

Principal Investigator: Nicole Ennis, Associate Professor

Completion Date (primary or actual): 2023-08-31

CT.gov Identifier: NCT04629716

A Study of Atorvo+™ in Healthy Adult Participants

A Phase 1 study will assess the safety, tolerability, and pharmacokinetics of Atorvo+™ in healthy adult participants. .

First Posted: 2024-09-26

Condition(s): Coronary Heart Disease, Dyslipidemias

Intervention(s): Atorvo+™ (Arm1), Atorvo+™ +CBD (Arm 2), Atorvo+™ +CBD (Arm 3)

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: NON_RANDOMIZED

Sponsor: Indication Bioscience LLC

Principal Investigator:

Completion Date (primary or actual): 2025-06-10

CT.gov Identifier: NCT06615284

Environment and Lung Cancer

Cannabis is the most consumed drug in the world and the French are the main consumers in Europe. The most recognized effects of cannabis on human health are of a neuro-psychic nature. The medical literature on the effects of cannabis on the lung in general, and on lung carcinogenesis in particular, is most often reassuring (Tashkin, Chest 2018; Zhang, Int J Cancer 2015; Ghasemiesfe JAMA Netw. Open. 2019), despite the fact that the concentration of carcinogens in cannabis smoke is higher than that contained in tobacco smoke (Moir, Chem. Res. Toxicol. 2008), and that cannabis smoking has been implicated in the occurrence of ENT cancers. Rather, research focuses on the therapeutic effects of cannabis, especially analgesics, and even on its possible anti-tumor virtues (Abrams, Jama Oncol. 2020). These reassuring data should, however, be viewed with a great deal of caution. On the one hand, the illegal nature of cannabis in most countries and its frequent association with tobacco consumption make studies on the subject difficult and often biased. On the other hand, the daily practice of oncologists, who observe numerous cases of advanced and rapidly progressive lung cancer occurring in young patients who are heavy users of cannabis, raises suspicion of an unrecognized role of cannabis in lung carcinogenesis. In a preliminary multicenter study on French patients under 50 years of age operated for primary lung cancer (Betser, ERJ 2021), we demonstrated that cannabis consumption was extremely frequent, concerning 43% of patients, but mentioned in patients' medical records only in 4 out of 10 cases, while the smoking status was always noted. In addition, by comparing people who smoke cannabis (always here associated with tobacco) to patients who only smoke tobacco or to non-smokers, we identified a different profile of lung cancers, with more poorly differentiated tumors, presenting at a more advanced stage (more T3-T4 versus T1-T2) requiring more complex surgery, and mostly located in the upper lobes of the lung. Similar research work is currently underway at Gustave Roussy (Dr Pradere-Dr Planchard, Villejuif, France) on patients with metastatic lung cancer, with a focus on overall survival and molecular profile.

First Posted: 2021-11-15

Condition(s): Cannabis Use

Intervention(s): blood and hair sampling

Status: RECRUITING

Enrollment (expected or actual): 150

Allocation: NON_RANDOMIZED

Sponsor: Centre Chirurgical Marie Lannelongue

Principal Investigator:

Completion Date (primary or actual): 2027-02-01

CT.gov Identifier: NCT05119244

Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples

The goal of this clinical trial is to develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are: * Will the intervention be feasible and acceptable to young adult couples? * Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning? Eligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up. Researchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up.

First Posted: 2024-05-20

Condition(s): Alcohol Drinking, Cannabis Use, Couples

Intervention(s): Online, couples-based intervention

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Katherine Walukevich-Dienst, Acting Assistant Professor, School of Medicine

Completion Date (primary or actual): 2027-10-01

CT.gov Identifier: NCT06422299

The Sunnybrook Dementia Study

The prospect of disease-modifying therapies in the pipeline for Alzheimer's Disease (AD) has intensified efforts to use brain imaging more effectively for diagnosis and monitoring of dementing illnesses. There is also emerging awareness of the destructive interplay between AD and Cerebrovascular Disease (CVD) in our aging population; both disorders share common vascular risk factors and may respond to similar prevention treatments. Brain mapping techniques capitalize on the fact that different neurodegenerative diseases target particular brain areas. Brain shrinkage and stroke disease can be quantified on Magnetic Resonance Imaging (MRI) using computerized analysis. This ongoing study applies advanced MR imaging analysis, genetic testing and standardized cognitive and functional assessments done at yearly intervals to measure and monitor longitudinal change in patients with AD, vascular and other neurodegenerative diseases and potentially to measure modifying effects of emerging therapies. Nearly 1800 patients (Mild Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and over 140 normal elderly have already been enrolled, with 180 autopsies. This study utilizes specialized imaging analysis software packages to reliably quantify brain tissue volumes and small vessel disease, the most common type of CVD. The SDS also investigates other potential biomarkers of dementia such as eye-tracking, optical coherence tomography, gait and balance, and the gut microbiome to explore their clinical utility. Results from this study will help to improve diagnosis, to customize treatment, and to better monitor disease-modifying therapies currently under investigation should they become applicable to everyday practice.

First Posted: 2013-02-27

Condition(s): Dementia

Intervention(s):

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 1800

Allocation:

Sponsor: Sunnybrook Health Sciences Centre

Principal Investigator: Dr. Sandra E Black, Brill Chair in Neurology

Completion Date (primary or actual): 2026-09

CT.gov Identifier: NCT01800214

Tirzepatide for the Treatment of Cannabis Use Disorder

This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.

First Posted: 2025-12-05

Condition(s): Cannabis Use Disorder

Intervention(s): Tirzepatide, Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 6

Allocation: RANDOMIZED

Sponsor: Brigham and Women's Hospital

Principal Investigator: Joji Suzuki, MD, Principal Investigator, Division of Addiction Treatment and Prevention, AMC Psychiatry Mass General Brigham

Completion Date (primary or actual): 2028-06-30

CT.gov Identifier: NCT07265752

Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.

First Posted: 2010-04-26

Condition(s): Cannabis Abuse, Cannabis Dependence

Intervention(s): Topiramate, Placebo

Status: COMPLETED

Enrollment (expected or actual): 66

Allocation: RANDOMIZED

Sponsor: Brown University

Principal Investigator: Robert Miranda, Associate Professor (Research)

Completion Date (primary or actual): 2012-05

CT.gov Identifier: NCT01110434

Montelukast in Parkinson Disease

Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease (AD). Clinical manifestations of PD can vary, but a formal diagnosis relies on the presence of bradykinesia with rigidity and/or rest tremor according to Movement Disorder Society (MDS) criteria for PD. Non-motor symptoms, such as hyposmia, constipation, depression, and rapid eye movement (REM) sleep behavior disorder, are common and can in many cases manifest before classical motor symptoms. In later years, more emphasis has been put on non-motor symptoms, especially in the early stages of PD and which is evident in the proposed prodromal PD criterion by MDS.

First Posted: 2023-11-02

Condition(s): Parkinson Disease

Intervention(s): levodopa-carbidopa, Montelukast

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Mostafa Bahaa

Principal Investigator: Mostafa Bahaa, Teaching assisstant

Completion Date (primary or actual): 2026-08-20

CT.gov Identifier: NCT06113640

Evaluation of Effects of CBD Products on Anxiety Among U.S. Women

The investigators will conduct a retrospective cohort analysis of a consumer trial conducted by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD) products. Participants were randomized to one of 9 groups: 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery, concentration of Tetrahydrocannabinol (THC), and dosage of CBD. Participants were asked to use the product once daily for 60 day and to complete health questionnaires at baseline, 30 days and 60 days.

First Posted: 2021-11-04

Condition(s): Anxiety, Generalized Anxiety Disorder

Intervention(s): Cannabidiol (CBD)- containing consumer products

Status: COMPLETED

Enrollment (expected or actual): 1350

Allocation:

Sponsor: Radicle Science

Principal Investigator:

Completion Date (primary or actual): 2020-12-30

CT.gov Identifier: NCT05108220

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors. This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839 capsules orally twice or three times daily. In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D) Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation tumors. As an extension of Parts 1 \& 2, patients will be treated with CB-839 in combination with standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo. Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated with cabozantinib in combination with CB-839. All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.

First Posted: 2014-02-26

Condition(s): Solid Tumors, Triple-Negative Breast Cancer, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Mesothelioma, Fumarate Hydratase (FH)-Deficient Tumors, Succinate Dehydrogenase (SDH)-Deficient Gastrointestinal Stromal Tumors (GIST), Succinate Dehydrogenase (SDH)-Deficient Non-gastrointestinal Stromal Tumors, Tumors Harboring Isocitrate Dehydrogenase-1 (IDH1) and IDH2 Mutations, Tumors Harboring Amplifications in the cMyc Gene

Intervention(s): CB-839, Pac-CB, CBE, CB-Erl, CBD, CB-Cabo

Status: COMPLETED

Enrollment (expected or actual): 210

Allocation: NON_RANDOMIZED

Sponsor: Calithera Biosciences, Inc

Principal Investigator:

Completion Date (primary or actual): 2019-03

CT.gov Identifier: NCT02071862

Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder

This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people.

First Posted: 2022-11-25

Condition(s): Autism Spectrum Disorder

Intervention(s): NTI164

Status: COMPLETED

Enrollment (expected or actual): 54

Allocation: RANDOMIZED

Sponsor: Fenix Innovation Group

Principal Investigator:

Completion Date (primary or actual): 2026-05-30

CT.gov Identifier: NCT05626959

Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion

Hypothesis: Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure (TLF) in patients with angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion. A total of 1000 patients (500 per each group) with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion will be enrolled. Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 1:1 ratio. Stratified randomization according to participating center, clinical presentation (acute coronary syndrome or stable ischemic heart disease), and type of bifurcation lesions (true or non-true) will be performed.

First Posted: 2023-01-30

Condition(s): Coronary Artery Disease

Intervention(s): Simple Crossover, Side branch opening

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 1000

Allocation: RANDOMIZED

Sponsor: Keimyung University Dongsan Medical Center

Principal Investigator: NAM, Chang-Wook, Professor

Completion Date (primary or actual): 2029-12-31

CT.gov Identifier: NCT05705362

Concentration of Receptors With Affinity for Cannabidiol and Cannabinol and the Effect on Chronic Orofacial Pain of Muscle Origin

The main aim of the presented project will be to examine the concentration of selected receptors (CB1, CB2, TRPV-1) showing affinity for binding to cannabidol (CBD) and cannabinol (CBN) in blood samples collected from people with chronic pain in the masticatory muscles and from people without this pain. Moreover, study participants will be examined by a qualified doctor, according to the validated and standardized international DC/TMD protocol (Diagnostic Criteria for Temporomandibular Disorders) and the criteria included in ICOP-1 (International Classification of Orofacial Pain, 1st edition). The nature and duration of pain, psychoemotional state and central sensitization (the phenomenon of increased reactivity of the nervous system to stimuli) will be determined using validated questionnaires. The obtained results will be subjected to statistical analysis in order to check the relationships between the examined parameters.

First Posted: 2024-05-08

Condition(s): Myalgia, Muscle Pain, Orofacial Pain, Headache, Tension, Headaches Muscular

Intervention(s): Blood CB1, CB2, TRPV-1 concentration measurement

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 102

Allocation:

Sponsor: Wroclaw Medical University

Principal Investigator: Joanna Smardz, Investigator

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT06405646

The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder

The goal of this clinical trial is to evaluate the effects of Cannabigerol (CBG) on indicators of Attention-Deficit/Hyperactivity Disorder (ADHD) in a sample of participants indicating/reporting symptoms associated with ADHD. The main question it aims to answer is: Does CBG reduce ADHD-related indicators relative to placebo? Participants will administer an acute dose of placebo or 80mg CBG and complete outcome measures at 45 minutes and 75 minutes. Daily surveys to monitor safety will be administered for one week following administration.

First Posted: 2023-11-03

Condition(s): Attention-Deficit/Hyperactivity Disorder

Intervention(s): Cannabigerol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 76

Allocation: RANDOMIZED

Sponsor: University of Arkansas, Fayetteville

Principal Investigator: Ellen Leen-Feldner, Professor

Completion Date (primary or actual): 2026-07

CT.gov Identifier: NCT06115603

Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease

This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia). Lecigon® is prescribed by physicians in advanced Parkinson's disease when patients suffer from uncontrollable fluctuations in mobility, so-called motor fluctuations, which cannot be adjusted well with oral treatment, i.e. medication for swallowing. In this study, data on the effect and possible side effects from everyday treatment with Lecigon® will be collected and scientifically evaluated. The study is intended to supplement the results of previous clinical studies with clinical data in routine medical care, collected from approximately 300 patients.

First Posted: 2021-09-14

Condition(s): Advanced Parkinson Disease

Intervention(s): Lecigon® based on European Medicines Agency (EMA) SmPC

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 312

Allocation:

Sponsor: Britannia Pharmaceuticals Ltd.

Principal Investigator:

Completion Date (primary or actual): 2026-10-07

CT.gov Identifier: NCT05043103

Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults

A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness of OnTrack (a smartphone application to self-monitor substance use and sexual behaviors among homeless young adults) plus a brief motivational intervention (BMI), in comparison to treatment as usual (TAU) at Covenant House New York (CHNY) for those with substance abuse problems and who engage in risky sex. Following referral, screening, and eligibility determination, 60 participants will complete informed consent and be randomly assigned to one of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at baseline, 2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption, marijuana use, HIV sexual risk behaviors, and other relevant variables.

First Posted: 2015-08-21

Condition(s): Alcohol Use, Marijuana Use, Sexual Behavior

Intervention(s): OnTrack, Treatment as Usual, Brief Motivational Interviewing

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator:

Completion Date (primary or actual): 2016-08

CT.gov Identifier: NCT02530645

Oral Cannabidiol for Opioid Withdrawal

This pilot study will examine the safety of the cannabinoid cannabidiol (Epidiolex) in a human laboratory model of clinically relevant withdrawal. The study will be a residential within-subject comparison; all participants will receive placebo dosing and active cannabidiol. Results may be used to support an R01 grant application to more closely examine this hypothesis.

First Posted: 2020-01-23

Condition(s): Opioid Withdrawal, Opioid Craving, Opioid Use Disorder

Intervention(s): Epidiolex, Placebo

Status: COMPLETED

Enrollment (expected or actual): 3

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2022-06-30

CT.gov Identifier: NCT04238754

Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks

The purpose of this study is to use non-invasive brain imaging methods (MEG and EEG) to characterize the effects of THC on brain activity during learning.

First Posted: 2022-12-08

Condition(s): THC

Intervention(s): THC, Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Jose Cortes, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2025-12-01

CT.gov Identifier: NCT05641766

Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)

The study will be performed in two parts: 1) The pharmacokinetic (PK) part and 2) The appetite and nutritional evaluation part. The PK part of study will be conducted in open label manner on 10 end stage kidney disease (ESKD) patients receiving maintenance hemodialysis (MHD) treatment. For the PK part, a starting dose of cannabis oil -1 drop of 3% cannabis oil once a day \[each drop contain 1.2 mg CBD (cannabidiol) and 1.2 mg of ∆9-THC (∆9-tetrahydrocannabinol)\], was judged to be safe for a first-in-MHD patient's administration. Escalation to the next higher dose and any dose adjustments of the next dose levels will be based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups. Once the first dosage proved to be safe, there will be a 2 fold increase from the first dose level (2 drops once a day) to the second dose level. The dose levels will be increased by 2-fold from the previous dose level, until basal hunger and prospective consumption ratings assessed by the visual analogue scale (VAS) will increase at least by 10 mm between screening and the study visits (change-from-baseline) . PK parameters will be evaluated after first dosage administration and after dosage increased. The appetite and nutritional evaluation part of study will be conducted as a 3-month, double-blind, parallel-group, placebo-controlled, single center study. The study population will include 30 ESKD patients receiving MHD treatment with different degrees of protein-energy wasting (PEW) defined as malnutrition-inflammation score (MIS) above 6. A total of 30 subjects will be randomized to treatment with either cannabis oil or matching placebo.

First Posted: 2018-09-10

Condition(s): Protein-Energy Malnutrition, Hemodialysis, Appetite Disorders

Intervention(s): Cannabis oil, Placebo/ Regular Oil

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Assaf-Harofeh Medical Center

Principal Investigator: ilia beberashvili MD, principal investigator

Completion Date (primary or actual): 2019-10-15

CT.gov Identifier: NCT03664141

Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

First Posted: 2021-06-28

Condition(s): Chronic Non-specific Low Back Pain

Intervention(s): VER-01, Placebo

Status: COMPLETED

Enrollment (expected or actual): 820

Allocation: RANDOMIZED

Sponsor: Vertanical GmbH

Principal Investigator:

Completion Date (primary or actual): 2024-03-26

CT.gov Identifier: NCT04940741

Rimonabant to Reduce Alcohol Consumption

This study will examine whether Rimonabant, a drug that blocks cannabinoid-1 (CB1) receptors in the brain, affects alcohol consumption. Substances called endocannabinoids, which have many of the same effects of marijuana, bind to CB1 receptors. Animal studies show that when CB1 receptors are blocked, the animals consume less alcohol. Healthy normal volunteers between 21 and 40 years of age who consume between 20 and 40 alcoholic drinks per week, drink at least 4 days a week, and are not seeking treatment for alcoholism may be eligible for this study. Candidates are screened with a medical history, including questions about alcohol and drug use, physical examination, blood and urine tests, breath alcohol test, and electrocardiogram. Participants are asked about their mental health history and use of alcohol, cigarettes and illicit drugs, and fill out questionnaires evaluating their emotional state and personality. Then, they begin a baseline evaluation in which they call a number at the NIH Clinical Center for 21 days to report how much alcohol they drank that day. One week after starting the baseline evaluation, they are randomly assigned to take either Rimonabant or placebo (a pill with no active ingredient) for 2 weeks. Before starting the drug, they have a urine drug screen and measurement of blood alcohol level. After 1 week on the test medication, they return to the Clinical Center to monitor drug or placebo side effects, if any, and to have a blood alcohol level test, urine drug screen, and blood tests for routine blood chemistries. After 2 weeks on the test medication, they come to the Clinical Center at noon for an alcohol self-administration test. Before the test, they are given a breath alcohol test and a urine drug test. The results of both tests must be negative to continue in the study. The alcohol self-administration test is videotaped. A heparin lock is placed in a vein in the participant's arm. This small needle remains in the arm for the duration of the study to avoid multiple needle sticks for blood draws. Blood is drawn periodically during the test to determine routine laboratory values, cotinine level (assessment of smoking status), the amount of Rimonabant or placebo in the body, and levels of various hormones. Thirty minutes before the test begins and every 30 minutes during the test, participants complete questionnaires and rating scales regarding their mood and desire to drink. Five minutes before the test be...

First Posted: 2004-01-06

Condition(s): Healthy, Alcohol Drinking

Intervention(s): SR141716 (Rimonabant)

Status: COMPLETED

Enrollment (expected or actual): 54

Allocation:

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Principal Investigator:

Completion Date (primary or actual): 2007-03-15

CT.gov Identifier: NCT00075205

CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

The goal of this feasibility study is to learn whether Cannabidiol (CBD) can improve urinary incontinence and other symptoms in people with recent spinal cord injury (SCI). Participants will take Epidiolex (purified CBD) for 90 days

First Posted: 2025-02-21

Condition(s): Supra-sacral Spinal Cord Injury, Spinal Cord Injury, Urinary Incontinence

Intervention(s): CBD

Status: RECRUITING

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: University of Wisconsin, Madison

Principal Investigator:

Completion Date (primary or actual): 2028-05

CT.gov Identifier: NCT06840899

Fire Dragon Pot Moxibustion

Insomnia in perimenopausal women is normal. Studies have shown that insomnia occurs in 75-81% of perimenopausal women and is 2.4 times more common than in premenopausal participants. Western medicine often uses sedative sleeping drugs in the treatment of insomnia in perimenopausal women, which have better effects but have more side effects, and whether they are suitable for long-term application is still controversial. Non-pharmacological traditional therapies in Traditional Chinese Medicine have achieved significant clinical efficacy in the treatment of perimenopausal insomnia patients in recent years. This study aims to explore the efficacy of auricular point seed burying combined with fire dragon pot moxibustion in the treatment of the insomnia symptoms of perimenopausal women.

First Posted: 2022-02-10

Condition(s): Insomnia, Perimenopause

Intervention(s): Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy., Traditional Chinese Medicine auricular acupuncture point buried seeds therapy

Status: COMPLETED

Enrollment (expected or actual): 70

Allocation: RANDOMIZED

Sponsor: Weihua Yu

Principal Investigator: Weihua Yu, Director of nursing department

Completion Date (primary or actual): 2020-10-30

CT.gov Identifier: NCT05234814

Cannabidiol Treatment for Severe and Critical Coronavirus (COVID-19) Pulmonary Infection

Current management of COVID-19 (coronavirus) is mainly supportive, and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with severe acute respiratory syndrome (SARS). Cannabidiol (CBD), a nonpsychotropic ingredient of Cannabis sativa, possesses potent anti-inflammatory and immunosuppressive properties. These effects are mediated by T cell attrition and by inhibition of pro-inflammatory cytokine release (tumor necrosis factor-a, Interferon gamma, IL-1b, IL-6, and IL-17) and stimulation of anti-inflammatory cytokine production (IL-4, IL-5, IL-10, and IL-13). In a number of phase 2 trials involving more than 100 patients, our group was able to show the safety and efficacy of CBD in the prevention and treatment of graft-versus-host disease. Based on these data, we will test the cytokine profile, safety and efficacy of CBD treatment in patients with severe and critical COVID-19 infection.

First Posted: 2021-01-29

Condition(s): COVID-19

Intervention(s): Cannabidiol

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: NA

Sponsor: Rabin Medical Center

Principal Investigator: moshe yeshurun, Head BMT Unit

Completion Date (primary or actual): 2022-04-30

CT.gov Identifier: NCT04731116

Individual Differences in Drug Response

Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute oral THC will be administered in a double-blind and counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses of estradiol and progesterone and self-reported responses. The main hypothesis is circulating estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response. The rationale for the presented work is to better understand the risks of cannabis use, in order to maximize possible medical potential and minimize public health risks. The expected outcome of this work is a deeper understanding of how circulating estradiol levels may associate with response to THC and how the physiological response is associated with the subjective response. Uncovering the individual differences in response to THC will allow for more preventive action against cannabis-induced anxiety, paranoia, and psychosis.

First Posted: 2019-01-18

Condition(s): Differential Female Response to Δ9-tetrahydrocannabinol (THC)

Intervention(s): Dronabinol, dextrose

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: University of Chicago

Principal Investigator:

Completion Date (primary or actual): 2021-06-01

CT.gov Identifier: NCT03809546

Common Bile Duct Pressure After Surgical Exploration

A study that included patients of any gender between 15 and 70 years, with the diagnosis of choledocholithiasis who required a cholecystectomy with an exploration of bile ducts. Conventional cholecystectomy was performed and a T-tube was inserted in the common bile duct (CBD) to measure the intraluminal pressure immediately after the procedure, and weekly thereafter, with a 6-week follow-up. A control T-tube radiological study was performed at six weeks to exclude residual stones.

First Posted: 2021-07-20

Condition(s): Choledocholithiasis

Intervention(s): Cholecystectomy and common bile duct exploration

Status: COMPLETED

Enrollment (expected or actual): 13

Allocation: NA

Sponsor: Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo

Principal Investigator: Carlos R. Cervantes Sanchez, MD, MSc, General Surgery Service

Completion Date (primary or actual): 2001-11

CT.gov Identifier: NCT04968873

Cannabidiol for Anxiety

This pilot trial seeks to investigate the effect of 25 mg full-spectrum CBD soft gel capsules (up to a total dosage of 100mg per day) on individuals with diagnosed anxiety. All participants will take CBD soft gel capsules for 12 weeks, and will be assessed at 6 weeks and 12 weeks post-enrollment using measures of anxiety, sleep and perception of change.

First Posted: 2020-02-13

Condition(s): Anxiety

Intervention(s): Cannabidiol

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: NA

Sponsor: CB2 Insights

Principal Investigator:

Completion Date (primary or actual): 2020-12-01

CT.gov Identifier: NCT04267679

Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD

When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The tube passes beyond the stomach and into an opening in the liver called the bile duct. Another small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile duct to ensure that there are no cancers or stones in the bile duct and occasionally to take a sample from the bile duct. The purpose of our study is to examine wither performing this procedure can transmit bacteria from the bile duct to the main blood stream.

First Posted: 2012-08-27

Condition(s): Choledocholithiasis, Cholangiocarcinoma, Benign Stricture of Common Bile Duct

Intervention(s): Blood culture ( aerobic and anaerobic)

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: NA

Sponsor: Texas Tech University Health Sciences Center, El Paso

Principal Investigator: Mohamed O Othman, Assistant Professor

Completion Date (primary or actual): 2013-10

CT.gov Identifier: NCT01673269

Drug-Drug Interaction Between THC and AEF0117

This trial is a single center, double blind, placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence. The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis.

First Posted: 2024-05-02

Condition(s): Cannabis Abuse

Intervention(s): 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Aelis Farma

Principal Investigator:

Completion Date (primary or actual): 2026-06

CT.gov Identifier: NCT06395688

ADDIA Proof-of-Performance Clinical Study

The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease (AD). ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance study with only one visit. About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD) and 200 control subjects (healthy as compared to their age). * 400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with moderate-to-severe AD, * 200 patients with non-Alzheimer's neurodegenerative diseases (NAD), * 200 controls (healthy as compared to their age).

First Posted: 2017-01-25

Condition(s): Alzheimer Disease (AD), Frontotemporal Lobar Degeneration, Dementia with Lewy Bodies (DLB), Parkinson Disease Dementia (PDD), Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)

Intervention(s): volumetric MRI

Status: COMPLETED

Enrollment (expected or actual): 821

Allocation:

Sponsor: Amoneta Diagnostics SAS

Principal Investigator:

Completion Date (primary or actual): 2023-06-30

CT.gov Identifier: NCT03030586

A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers

Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.

First Posted: 2019-09-24

Condition(s): Erectile Dysfunction, Smoking, Pharmacokinetics, Pharmacodynamics

Intervention(s): Sildenafil 50 mg Oral Tablet

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Ain Shams University

Principal Investigator: Mohamed Raslan, QC Manager and Clinical pharmacy Msc student

Completion Date (primary or actual): 2019-07-08

CT.gov Identifier: NCT04100759

Avenanthramides and Exercise

The aim of the proposed study is to examine whether long-term dietary supplementation (8 weeks) of an oat flour cookie rich in avenanthramides (AVA) could enhance blood antioxidant capacity and reduce blood inflammatory markers after a downhill running (DR) protocol among human subjects.

First Posted: 2015-10-23

Condition(s): Avenanthramides

Intervention(s): Avenanthramides

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: PepsiCo Global R&D

Principal Investigator:

Completion Date (primary or actual): 2016-07-05

CT.gov Identifier: NCT02584946

Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty

The goal of this study is to better understand how daily treatment with cannabidiol (CBD) affects the need for opioid pain medication, as well as pain, inflammation and other related symptoms, after knee replacement surgery. The information collected in this study is necessary to help understand whether CBD may be a useful medication before and/or after surgery. The study hypothesis is that CBD exerts opioid-sparing effects through anti-inflammatory, analgesic, and anxiolytic mechanisms.

First Posted: 2024-01-31

Condition(s): Knee Replacement Surgery, Osteoarthritis, Knee

Intervention(s): Epidiolex oral solution, Placebo

Status: RECRUITING

Enrollment (expected or actual): 380

Allocation: RANDOMIZED

Sponsor: Chad Brummett

Principal Investigator: Chad Brummett, Professor of Anesthesiology Research, Associate Chair for Research

Completion Date (primary or actual): 2029-01

CT.gov Identifier: NCT06234631

Impact of Food Intake on Berberine Kinetics

The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 (OCT-1) on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to expectations, the previously observed sex difference could not be confirmed. In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, the participants ate a meal. Shortly after meal intake, the plasma concentration curve peaked again. BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, the investigators will also measure insulin and glucose after the meal at noon. As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One by measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively. 24 healthy volunteers with an equal ratio of man and women will be enrolled.

First Posted: 2024-02-22

Condition(s): Pharmacokinetic Study in Healthy Volunteers

Intervention(s): food intake

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: University Medicine Greifswald

Principal Investigator: Stefan Engeli, MD, Professor

Completion Date (primary or actual): 2024-05-11

CT.gov Identifier: NCT06273241

Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder

This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673) and INS011-15-054 (NCT02551731).

First Posted: 2014-12-17

Condition(s): Seizures

Intervention(s): Cannabidiol Oral Solution

Status: COMPLETED

Enrollment (expected or actual): 52

Allocation: NON_RANDOMIZED

Sponsor: INSYS Therapeutics Inc

Principal Investigator:

Completion Date (primary or actual): 2017-06-22

CT.gov Identifier: NCT02318602

Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy

The goal of this observational study is to evaluate the associations between patient-directed medical cannabis use and chemotherapy-induced nausea and vomiting (CINV), as well as other treatment-related symptoms, among patients receiving chemotherapy that is known to cause nausea. The main questions it aims to answer are: * Is patient-directed medical cannabis use associated with reduced nausea severity during chemotherapy treatment? * Is-patient directed medical cannabis use associated with improved CINV control? * Is patient directed medical cannabis use associated with improved appetite during chemotherapy treatment? * Is patient-medical cannabis use associated with reduced treatment-related side effects, such as fatigue, sleep disturbances, general pain, and peripheral neuropathic pain? Researchers will compare participants who report using medical cannabis with participants who do not report using medical cannabis to determine whether differences exist in nausea, CINV outcomes, and other treatment-related symptoms. Participants will be followed over the course of 3 chemotherapy cycles, and asked to complete questionnaires, nausea diaries, and partake in a blood sample collection. Study participation can last from 6 - 12 weeks, depending on their prescribed chemotherapy cycle frequency.

First Posted: 2026-01-29

Condition(s): Nausea and Vomiting Chemotherapy-Induced

Intervention(s): Medical Cannabis

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 50

Allocation:

Sponsor: University of Rochester

Principal Investigator: Luke Peppone, Associate Professor - Department of Surgery, Cancer Control (SMD)

Completion Date (primary or actual): 2028-03-01

CT.gov Identifier: NCT07374939

The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy

The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical function and the autonomic nervous system in children with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained through state dispensaries or other sources. The intent is to begin to assess potential risks and benefits of this therapy in a vulnerable patient population by characterizing the effects of CBD on EKG findings, heart rate variability and the occurrence of seizures.

First Posted: 2016-06-28

Condition(s): Lennox-Gastaut Syndrome, Dravet Syndrome

Intervention(s): 12-Lead ECG, Cannabidiol

Status: TERMINATED

Enrollment (expected or actual): 2

Allocation: NA

Sponsor: Gillette Children's Specialty Healthcare

Principal Investigator:

Completion Date (primary or actual): 2018-12-01

CT.gov Identifier: NCT02815540

Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress Disorder

The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in participants with chronic, treatment-resistant posttraumatic stress disorder.

First Posted: 2015-08-07

Condition(s): Posttraumatic Stress Disorder

Intervention(s): High THC/Low CBD Cannabis, High THC/High CBD Cannabis, Low THC/Low CBD Cannabis

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: RANDOMIZED

Sponsor: Tilray

Principal Investigator:

Completion Date (primary or actual): 2019-03-22

CT.gov Identifier: NCT02517424

Research Evaluating Sleep & Trends for Universal Prevention

This study is designed to develop an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

First Posted: 2021-03-05

Condition(s): Insomnia, Alcohol Use, Unspecified, Marijuana Use

Intervention(s): Brief Behavioral Therapy for Insomnia (BBTI), Brief Alcohol Screening and Intervention for College Students (BASICS)

Status: COMPLETED

Enrollment (expected or actual): 150

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Mary Larimer, Professor, School of Medicine

Completion Date (primary or actual): 2023-07-31

CT.gov Identifier: NCT04783519

Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation

A large body of evidence on depression heterogeneity point to an "immunometabolic" subtype characterized by the clustering of immunometabolic dysregulations with atypical behavioral symptoms related to energy homeostasis. Motivational and motor impairments reflected by symptoms of anhedonia and psychomotor retardation in major depression are closely related to alterations in energy homeostasis, are associated with increased inflammation, and may be a direct consequence of the impact of inflammatory cytokines on the dopamine system in the brain. In the proposed project, the investigators will examine the effect of dopamine stimulation on motivation and motor function in patients with major depression and healthy controls and the role of inflammation using a double-blind, randomized, placebo-controlled, cross-over design. If successful, this study would provide crucial evidence that pharmacologic strategies that increase dopamine may effectively treat inflammation-related symptoms of anhedonia and psychomotor retardation in major depression.

First Posted: 2023-06-18

Condition(s): Depressive Disorder, Major

Intervention(s): L-dopa/Carbidopa, Placebo

Status: RECRUITING

Enrollment (expected or actual): 165

Allocation: RANDOMIZED

Sponsor: Charite University, Berlin, Germany

Principal Investigator: Woo Ri Chae, MD, Principal Investigator

Completion Date (primary or actual): 2026-07

CT.gov Identifier: NCT05909267

The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.

First Posted: 2009-05-05

Condition(s): Marijuana Dependence

Intervention(s): eszopiclone, Placebo, ramelteon, zolpidem

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator: Ryan Vandrey, Associate Professor

Completion Date (primary or actual): 2010-10

CT.gov Identifier: NCT00893269

Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive Learning and Executive Function

The study design is to assess the between groups factor (controls, chronic pain, addicted individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a longitudinal component to assess stress, pain and addictive behaviors in daily life.

First Posted: 2020-06-05

Condition(s): Pain Response, Stress, Trauma

Intervention(s): Yale Stress Pain Test (YSPT)

Status: COMPLETED

Enrollment (expected or actual): 81

Allocation:

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): 2023-12-30

CT.gov Identifier: NCT04419831

Testing the Efficacy of the Cannabis Clinic for Patients With Psychosis (CCP) Intervention for Cannabis Use Reduction/Cessation in Patients With First Episode Psychosis (FEP)

People suffering from psychosis who use cannabis experience more relapses, long and compulsory admissions, with huge costs to the individual, families and health services. The Cannabis Clinic for Psychosis (CCP) was developed to respond to this clinical need. A published review of the CCP's intervention showed its safety and efficacy in supporting people suffering from psychosis with reducing their cannabis use. Nevertheless, for the CCP model of care to be applied widely and benefit a larger clinical population, its intervention needs to be tested in a Randomised Control Trial (RCT). The proposed CCP RCT is a waiting list randomised controlled trial that aims to evaluate the clinical efficacy of the existing CCP intervention. Participants will be adults currently under the care of South London and Maudsley (SLaM) Early Intervention Teams for first onset psychosis, who are dependent on cannabis and who express an intention to reduce or stop their use. The RCT primary outcome will measure changes in all participants' cannabis use. Participants will be randomised to either the intervention group or the waiting list control group receiving Treatment As Usual (TAU). The CCP intervention comprises 12 weekly (+/- 4 weeks) one-to-one sessions, with optional participation in a weekly online peer group. Sessions are delivered by trained clinicians and include evidence-based psychosocial techniques, including Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), SMART goal settings and support for co-occurring tobacco use. The treatment is non-pharmacological and administered via participant-led approach that accommodates online or face-to-face sessions to meet the patient preference. Qualitative data from the recent CCP proof of concept paper indicate that the flexibility in allowing patients choice on the session's modality (online/face to face, hybrid) increased and maintained engagement. The study is fully funded by the Maudsley Charity and due to last 30 months from the start of recruitment.

First Posted: 2025-11-24

Condition(s): Psychosis, Cannabis Use Disorder, First Episode Psychosis (FEP)

Intervention(s): CCP Intervention

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: King's College London

Principal Investigator:

Completion Date (primary or actual): 2028-11-30

CT.gov Identifier: NCT07245212

Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy

The purpose of this study is to evaluate RLS103 for safety and suppression of the epileptic photoparoxysmal response compared to placebo.

First Posted: 2023-01-10

Condition(s): Epilepsy

Intervention(s): High dose RLS103, placebo inhaled powder, Low dose RLS103

Status: TERMINATED

Enrollment (expected or actual): 2

Allocation: RANDOMIZED

Sponsor: Receptor Life Sciences

Principal Investigator:

Completion Date (primary or actual): 2024-02-23

CT.gov Identifier: NCT05678881

Multi-Center Study of Natural History in Atypical Parkinsonian Syndromes (MAPS-NH)

This goal of this observational study is to clarify the variations in the natural course of atypical parkinsonian syndromes (APS, including MSA, DLB, PSP, and CBD), such as the progression rate of motor and non-motor symptoms and characteristic imaging evolution patterns. Establish a comprehensive assessment framework for APS, and develop clinical and biological databases to identify biomarkers with early predictive value.

First Posted: 2026-09-08

Condition(s): Multiple System Atrophy, Dementia With Lewy Bodies (DLB), Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)

Intervention(s): We did not apply any interventions; only observational research was conducted.

Status: RECRUITING

Enrollment (expected or actual): 500

Allocation:

Sponsor: Second Affiliated Hospital of Soochow University

Principal Investigator:

Completion Date (primary or actual): 2030-08-31

CT.gov Identifier: NCT07805967

Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.

First Posted: 2021-10-04

Condition(s): Cyclic Vomiting Syndrome

Intervention(s): Droperidol, Haloperidol, Ondansetron 8mg

Status: TERMINATED

Enrollment (expected or actual): 32

Allocation: RANDOMIZED

Sponsor: Corewell Health South

Principal Investigator:

Completion Date (primary or actual): 2023-11-20

CT.gov Identifier: NCT05065567

Comparison Between Low Pressure Pneumoperitoneum with High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy

This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of pain and common bile duct injuries in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum versus high pressure pneumoperitoneum.

First Posted: 2024-06-07

Condition(s): Cholecystectomy, Pneumoperitoneum, Pain, Postoperative

Intervention(s): Changing pressure of Pneumoperitoneum to 6-10 mmHg, Changing pressure of Pneumoperitoneum to 12-15 mmHg

Status: UNKNOWN

Enrollment (expected or actual): 82

Allocation: RANDOMIZED

Sponsor: Gulab Devi Hospital

Principal Investigator: Zain Himayoun, Principal Investigator

Completion Date (primary or actual): 2025-11-30

CT.gov Identifier: NCT06447545

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants

This is a Phase 1b, randomized, open-label, active-controlled, parallel, multiple-dose study comparing the safety, pharmacokinetics and efficacy of DehydraTECH Cannabidiol and Glucagon-like Peptide 1 (GLP-1) agonists alone and in combination, in overweight or obese, pre- and type 2 diabetic participants.

First Posted: 2024-10-18

Condition(s): Type2diabetes

Intervention(s): Arm 1 - DehydraTECH-CBD alone, Arm 2 - DehydraTECH-semaglutide alone, Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide, Arm 4 - Rybelsus medication (semaglutide) alone, Arm 5- Tirzepatide

Status: COMPLETED

Enrollment (expected or actual): 148

Allocation: RANDOMIZED

Sponsor: Lexaria Bioscience Corp.

Principal Investigator:

Completion Date (primary or actual): 2025-07-31

CT.gov Identifier: NCT06648031

TECH App Marijuana Use Intervention for Court-Involved Adolescents

The study is about helping teens who are involved in the court system to cut down or quit using marijuana. Teens may be asked to test out an experimental smartphone app, called TECH, that will be used only by teens in this study. This app is a private online community where teens can work towards changing their substance use and other behavior with the help of other anonymous teens. We will use this information to learn how the app may help teens make a change and to improve the TECH app.

First Posted: 2023-08-07

Condition(s): Cannabis Use, Adolescent

Intervention(s): Treatment as usual, Teen Empowerment through Computerized Health (TECH) app

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Northwestern University

Principal Investigator: Sarah Helseth, Assistant Professor

Completion Date (primary or actual): 2026-01-15

CT.gov Identifier: NCT05979272

Repeated CBD Administration and Cannabis Outcomes

This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.

First Posted: 2026-02-27

Condition(s): Cannabis, Abuse Liability, Experimental Pain in Healthy Human Participants

Intervention(s): Cannabidiol, Medium Dose, Cannabidiol, Higher Dose, Active Inhaled Cannabis, Placebo Cannabidiol, Placebo Inhaled Cannabis

Status: RECRUITING

Enrollment (expected or actual): 23

Allocation: RANDOMIZED

Sponsor: Hannah Harris

Principal Investigator: Hannah Harris, Assistant Professor

Completion Date (primary or actual): 2029-12-01

CT.gov Identifier: NCT07434895

A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.

This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.

First Posted: 2024-07-22

Condition(s): Rheumatoid Arthritis, Inflammatory Disease

Intervention(s): Cannabigerol (CBG)

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 12

Allocation: NA

Sponsor: Raphael Pharma

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT06513507

Cannabis Edibles Packaging Descriptors Experiment

The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without product descriptors of interest.

First Posted: 2023-12-14

Condition(s): Cannabis Use

Intervention(s): "All Natural" descriptor, "Gluten-free" descriptor, "Vegan" descriptor, "100% Organic" descriptor, "Handcrafted" descriptor, "Made with live resin" descriptor, "Fast-acting" descriptor, "Relax" descriptor, "Energy Boost" descriptor, No descriptor (control)

Status: COMPLETED

Enrollment (expected or actual): 2521

Allocation: RANDOMIZED

Sponsor: Wake Forest University Health Sciences

Principal Investigator:

Completion Date (primary or actual): 2024-04-15

CT.gov Identifier: NCT06171399

Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients

This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) "mental health" inpatient wards, providing the first detailed information on morbidity in this patient population.

First Posted: 2026-02-09

Condition(s): Bipolar Affective Disorder, Schizophrenia Disorders, Depression Disorders, Personality Disorders

Intervention(s): Questionnaires, rating scales, & review of notes

Status: RECRUITING

Enrollment (expected or actual): 100

Allocation:

Sponsor: University of Edinburgh

Principal Investigator:

Completion Date (primary or actual): 2026-12-31

CT.gov Identifier: NCT07398365

Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department

The aim of the study is to identify which medication (haloperidol or olanzapine) is most effective in treating nausea and abdominal pain associated with cannabinoid hyperemesis using a 10-point visual analog scale with intervals of 0.5.

First Posted: 2025-11-24

Condition(s): Cannabinoid Hyperemesis Syndrome

Intervention(s): Olanzapine 10 milligram, Haloperidol

Status: COMPLETED

Enrollment (expected or actual): 31

Allocation: RANDOMIZED

Sponsor: Mercy Bon Secours Saint Vincent Medical Center

Principal Investigator: Joseph Jabour, Dr. Joseph Jabour DO FACEP

Completion Date (primary or actual): 2026-10-01

CT.gov Identifier: NCT07246187

Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

There is a credible basis for lateral prefrontal cortex and insula deep repetitive transcranial magnetic stimulation (dTMS) stimulation as a treatment for cannabis use disorder (CUD), but no studies to date have examined this. Evidence of benefit could expand the treatment options available for CUD but require randomized controlled trials (RCTs) to evaluate its efficacy. Toward an RCT of this intervention, the proposed study is a phase 1 open-label pilot trial of dTMS for adults with CUD. This study will establish the viability of an H4 protocol constituting an active arm of a future double-blind RCT.

First Posted: 2023-11-02

Condition(s): Cannabis Use Disorder

Intervention(s): dTMS stimulation via the H4 coil

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: NA

Sponsor: St. Joseph's Healthcare Hamilton

Principal Investigator: James MacKillop, Director, Peter Boris Centre for Addiction Research; Director, Michael G. DeGroote Centre for Medicinal Cannabis Research

Completion Date (primary or actual): 2025-04-17

CT.gov Identifier: NCT06114212

A Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults

The bioavailability of cannabinoids differs greatly for different routes of administration. When applied topically to the skin, they are absorbed through the skin or hair follicles while interacting with receptors to provide localized effects. To gain more information on the potential of this route of administration in therapeutic applications, this open-label study will investigate the skin absorption and bioavailability of CBD and THC delivered trans-dermally.

First Posted: 2021-11-16

Condition(s): Biological Availability, Skin Absorption, CBD, THC

Intervention(s): CBD and THC with GT4 technology

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: NA

Sponsor: Gefion Canada Inc.

Principal Investigator:

Completion Date (primary or actual): 2022-01-18

CT.gov Identifier: NCT05121506

Using Ecological Momentary Assessment to Develop an Adaptive Psychological Intervention for Young Adults With Chronic Pain

The goal of this observational study is to determine real-time contextual vulnerabilities associated with pain in young adults to inform ideal treatment targets for a just-in-time adaptive intervention (JITAI). The main question it aims to answer is: -What contextual factors and vulnerabilities will predict momentary, next-day, and weekly pain severity? 50 young adults, ages 18-25 with a diagnosis of childhood-onset primary chronic pain, will complete 1) baseline questionnaires on REDCap to collect data on sociodemographics, medical history and treatment, psychological health (i.e., current mood symptoms and previous psychiatric conditions/treatment), and pain (e.g., duration, location) and 2) a 28-day EMA via mobile app to collect survey data on dynamic factors.

First Posted: 2025-04-17

Condition(s): Chronic Pain

Intervention(s):

Status: RECRUITING

Enrollment (expected or actual): 50

Allocation:

Sponsor: Seattle Children's Hospital

Principal Investigator: Caitlin Murray, Assistant Professor

Completion Date (primary or actual): 2027-12

CT.gov Identifier: NCT06932432

To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer

Phase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue.

First Posted: 2023-08-01

Condition(s): Breast Cancer, Oral Cancer

Intervention(s): Cannabis capsules

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 12

Allocation: NA

Sponsor: Tata Memorial Hospital

Principal Investigator: Dr Rajendra A. Badwe, Doctor

Completion Date (primary or actual): 2026-12-30

CT.gov Identifier: NCT05969314

CBD-Microglia PET Study

This study aims to examine the effect of cannabidiol (CBD) pre-treatment on brain microglial activation in healthy human subjects. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects.

First Posted: 2020-05-21

Condition(s): CBD, Healthy

Intervention(s): [11C]PBR28, Low-dose lipopolysaccharide, Intradermal Capsaicin

Status: COMPLETED

Enrollment (expected or actual): 28

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, Associate Professor of Psychiatry

Completion Date (primary or actual): 2024-12-11

CT.gov Identifier: NCT04398719

Marijuana Treatment Project 4

Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions

First Posted: 2014-01-08

Condition(s): Marijuana Dependence

Intervention(s): Contingency Management, Individualized Assessment & Treatment, Cognitive-Behavioral Treatment

Status: COMPLETED

Enrollment (expected or actual): 198

Allocation: RANDOMIZED

Sponsor: UConn Health

Principal Investigator: Mark Litt, Professor

Completion Date (primary or actual): 2018-04

CT.gov Identifier: NCT02030665

Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients

The purpose of this study is to determine the effect of two different multiple-dose regimens of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of levodopa in Parkinson's Disease (PD) patients.

First Posted: 2016-07-15

Condition(s): Parkinson's Disease (PD)

Intervention(s): Placebo, BIA 3-202, Comtan®, Sinemet®

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2005-11

CT.gov Identifier: NCT02834507

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

The aim of the present study is evaluating the strength of combination therapy of hydroxy urea, omega 3, nigella sativa and honey on antioxidant-oxidant status (OXIDATIVE STRESS) in response to reactive oxygen species production (LIPID PEROXIDATION) and their effect on iron intoxication (IRON CHELATION) in pediatric major thalassemia.

First Posted: 2020-03-03

Condition(s): Iron Overload, Oxidative Stress, Thalassemia Major

Intervention(s): Omega 3, Nigella Sativa Oil, Hydroxyurea, Honey, Deferoxamine, blood transfusion session

Status: COMPLETED

Enrollment (expected or actual): 350

Allocation: RANDOMIZED

Sponsor: Beni-Suef University

Principal Investigator: Mohamed Medhat Abdelwahab Gamaleldin, Dr.Mohamed Medhat Abdelwahab Gamaleldin

Completion Date (primary or actual): 2021-01-20

CT.gov Identifier: NCT04292314

Prospective Randomized Controlled Pilot Study of Gut Microbiome Modulation by Nigella Sativa Seed Oil and Thymoquinone Metabolism in Healthy Volunteers

For many patients, the additive use of dietary supplements without side effects is motivating for therapy and enhances quality of life. The oil of the plant Nigella sativa (NS), a dietary supplement containing Thymoquinone (TQ) as its main active compound, exhibits hepatoprotective effects through antioxidative, antifibrotic, and anti-inflammatory properties, and also demonstrates anticancer and antiapoptotic activities. In vitro and in vivo studies have shown that TQ can also influence the gut microbiome. However, no clinical studies are currently available that describe the specific extent of TQ's influence on the human intestinal microbiome and its potential effects on the outcome after gastrointestinal surgery. The aim of the project is therefore to investigate changes in the human microbiome following the intake of Nigella sativa seed oil capsules containing TQ as the main active ingredient. The study will test the hypothesis that TQ, through its diverse mechanisms of action, modulates the composition of the microbiome and thereby exerts a positive effect on immune response and intestinal healing processes. In parallel, TQ metabolites in urine will be analyzed using Liquid Chromatography-Mass Spectrometry (LC-MS) to gain insights into the pharmacokinetic profile of the compound.

First Posted: 2026-03-05

Condition(s): Changes in Human Gut Microbiome in Healthy Adults

Intervention(s): Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules

Status: COMPLETED

Enrollment (expected or actual): 8

Allocation: RANDOMIZED

Sponsor: Aysun Tekbaş

Principal Investigator: Aysun Tekbaş, Dr. med., MME

Completion Date (primary or actual): 2025-03-01

CT.gov Identifier: NCT07450807

Augmenting Effects of L-DOPS With Carbidopa and Entacapone

An experimental drug called L-DOPS increases production in the body of a messenger chemical called norepinephrine. Cells in the brain that make norepinephrine are often gone in Parkinson disease. The exact consequences of this loss are unknown, but they may be related to symptoms such as fatigue, depression, or decreased attention that occur commonly in Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the effects are of increasing norepinephrine production in the brain and whether carbidopa and entacapone augment those effects. Volunteers for this study must be at least 18 years of age and able to give consent to participate in the study. To participate in the study, volunteers must discontinue use of alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or discontinue certain kinds of medications that might interfere with the results of the study. Candidates will be screened with a medical history and physical exam. Participants will be admitted to the National Institutes of Health Clinical Center for two weeks of testing. The study will have three testing phases in a randomly chosen order for each participant: * Single dose of L-DOPS * Single dose of L-DOPS in conjunction with carbidopa * Single dose of L-DOPS in conjunction with entacapone Each phase will last two days, with a washout day between each phase in which no drugs will be given and no testing will be performed. In each phase, participants will undergo a series of tests and measurements, including blood pressure and electrocardiogram tests. Participants who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture (also known as a spinal tap) to obtain spinal fluid for chemical tests.

First Posted: 2007-10-23

Condition(s): Parkinson Disease, Multiple System Atrophy, Autonomic Nervous System Diseases

Intervention(s): Droxidopa, Carbidopa, Entacapone

Status: TERMINATED

Enrollment (expected or actual): 14

Allocation: NON_RANDOMIZED

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Principal Investigator:

Completion Date (primary or actual): 2013-04

CT.gov Identifier: NCT00547911

Enhancing Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse

Alcohol misuse is a common and disabling problem and refers to alcohol consumption that causes harm to the drinker, others, and/or greater society. Internet-delivered cognitive behaviour therapy (ICBT) shows considerable promise as a convenient treatment for alcohol misuse. The overall goal of ICBT for alcohol misuse is typically behavioural change, measured in terms of reduction of drinks consumed, as opposed to abstinence. These interventions can be delivered in a therapist-guided format or self-guided format. In past research on ICBT for alcohol misuse, stakeholders (e.g., patients, providers, and academics) highlighted the importance of ensuring that ICBT meets the needs of diverse residents of Saskatchewan, and that ICBT takes into account factors such as psychological comorbidity. Therefore, the goals of the current trial are to: 1) incorporate additional patient narratives to assist clients in learning how diverse individuals apply skills to their lives; and 2) provide additional optional resources to address potential co-morbid concerns. The study aims to examine how these materials are evaluated by clients. Furthermore, we will also examine the overall engagement and outcomes of the enhanced ICBT course for alcohol misuse benchmarked with past findings.

First Posted: 2022-09-26

Condition(s): Alcohol Misuse

Intervention(s): Self-Guided, Therapist-Guided

Status: COMPLETED

Enrollment (expected or actual): 205

Allocation: NON_RANDOMIZED

Sponsor: University of Regina

Principal Investigator:

Completion Date (primary or actual): 2025-07-03

CT.gov Identifier: NCT05555264

A Trial of Plerixafor/G-CSF as Additional Agents for Conditioning Before TCR Alpha/Beta Depleted HSCT in WAS Patients

Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after transplantation with TCR alpha/beta grafts depletion in patient with Wiskott-Aldrich syndrome.

First Posted: 2017-01-13

Condition(s): Wiskott-Aldrich Syndrome, Hematopoietic Stem Cell Transplantation, Graft Failure

Intervention(s): G-CSF for Conditioning before HSCT., Plerixafor for Conditioning before HSCT.

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: NA

Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Principal Investigator:

Completion Date (primary or actual): 2019-07

CT.gov Identifier: NCT03019809

Cannabis' Impact on Alcohol Consumption

This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.

First Posted: 2022-05-25

Condition(s): Alcohol Drinking, Cannabis Use, Cannabis, Alcohol Use Disorder

Intervention(s): THC-dominant cannabis, CBD-dominant cannabis, Cannabis placebo, Alcohol, Alcohol placebo

Status: RECRUITING

Enrollment (expected or actual): 350

Allocation: RANDOMIZED

Sponsor: Brown University

Principal Investigator:

Completion Date (primary or actual): 2027-12-31

CT.gov Identifier: NCT05389930

Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips

The goal of this clinical trial is to compare the efficacy of two different daily doses of tetrahydrocannabivarin impregnated mouth strips in healthy non-diabetic obese adults. The main questions to answer are: * Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels? * Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels? * Is one dose better than the other dose? Participants will take either the low dose, high dose or placebo dose daily for ninety days and have physical measurements and blood tests obtained at the beginning and the end of the study.

First Posted: 2022-10-10

Condition(s): Metabolic Syndrome, Morbid Obesity, Hypercholesterolemia, Hyperglycemia

Intervention(s): Tetrahydrocannabivarin, Placebo

Status: COMPLETED

Enrollment (expected or actual): 56

Allocation: RANDOMIZED

Sponsor: Medical Life Care Planners, LLC

Principal Investigator:

Completion Date (primary or actual): 2022-05-04

CT.gov Identifier: NCT05574049

Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.

First Posted: 2006-01-19

Condition(s): Primary Immunodeficiency, Common Variable Hypogammaglobulinemia, X-linked Hypogammaglobulinemia, Hypogammaglobulinemia, Immunodeficiency With Hyper-IgM, Wiskott-Aldrich Syndrome

Intervention(s): Gammaplex (Intravenous immunoglobulin)

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: NA

Sponsor: Bio Products Laboratory

Principal Investigator:

Completion Date (primary or actual): 2007-11

CT.gov Identifier: NCT00278954

Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials

The goal of this clinical trial is to learn if cannabidiol ("CBD-oil") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol. The main questions it aims to answer are: * Does cannabidiol lower the number of seizure in children with severe epilepsy? * Does cannabidiol effect other outcomes such as behaviour, sleep, communication, activities? * What medical problems do participants have when taking cannabidiol? Researchers will compare cannabidiol to a placebo (a look-alike oil that contains no cannabidiol) to see if drug cannabidiol works to treat severe epilepsy. All participants will receive both the cannabidiol and the placebo during different periods. At the end of the trial, we will evaluate for each patient seperately, whether seizures were less or more frequent during cannabidiol periods or placebo periods, to see what works best for every patient seperately. Participants will: * Register their seizures in a digital application during 4 to 6 periods. During these periods, CBD oil of placebo will be provided * Take CBD oil during 2 to 3 periods. One period will last around 7 weeks. * Also take placebo oil during the other 2 to 3 periods * Have a blood test every 7 weeks to monitor for safety and possible adverse effects * Visit the clinic once every 15 weeks for checkups and tests * Fill in questionnaires about quality of life, functioning, sleep, behaviour, epilepsy severity every 7 weeks.

First Posted: 2026-06-25

Condition(s): Refractory Epilepsy in Children, Refractory Epilepsy, Epilepsy

Intervention(s): Cannabidiol (CBD) oral solution, Placebo

Status: RECRUITING

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: UMC Utrecht

Principal Investigator: F.E. (Floor) Jansen, Associate Professor Pediatric Neurology

Completion Date (primary or actual): 2027-12

CT.gov Identifier: NCT07668856

Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions

This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.

First Posted: 2011-10-07

Condition(s): Bioavailability

Intervention(s): Dronabinol Capsules, 5 mg, Dronabinol Oral Solution

Status: COMPLETED

Enrollment (expected or actual): 88

Allocation: RANDOMIZED

Sponsor: INSYS Therapeutics Inc

Principal Investigator:

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT01448772

Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects

Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority. The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects. This will be a single center study in healthy male and non-pregnant female, non-treatment seeking, cannabis smoking subjects with cannabis use disorder (CUD). The study design will be a randomized, double-blind, placebo-controlled, cross-over design, multiple dose escalation study with AEF0117. This study is designed to test the effects of two to four doses of AEF0117 compared to placebo on primarily peak subjective effects of cannabis as primary objectives. The secondary objectives are to test the effects of AEF0117 compared to placebo on cannabis self-administration, on cannabis-induced analgesia and on cognitive performance in cannabis smoking subjects. The study hypothesis is that AEF0117 will decrease ratings of cannabis' positive subject effects (e.g., 'good drug effect', high) and decrease cannabis self-administration compared to placebo and also decrease the other unconditioned effects of cannabis studied here. Each subject will have a screening visit, then be included for two 6-day inpatient periods separated by a minimum 14-day outpatient washout. Subjects will be advised that they will receive both active and placebo study medication but will remain blinded to whether they will receive AEF0117 or placebo on Period A and Period B. Each period is composed of 5 consecutive days of treatment (active or placebo), one administration per day. Research staff that interacts with study subjects will also remain blinded to whether subjects are receiving AEF0117 or placebo. The study duration for the first 3 doses of AEF0117 is estimated to be approximately up to 10 months from the start of subject recruitment to the last subject last visit.

First Posted: 2018-10-24

Condition(s): Marijuana Abuse

Intervention(s): AEF0117, Placebo oral capsule

Status: COMPLETED

Enrollment (expected or actual): 29

Allocation: RANDOMIZED

Sponsor: Aelis Farma

Principal Investigator:

Completion Date (primary or actual): 2021-01-01

CT.gov Identifier: NCT03717272

Imaging Cannabinoid CB1 Receptors in Alcohol Dependence

The cannabinoid type 1 (CB1) receptor is a protein found in the brain that is involved with the effects of marijuana; it may also play a role in the effects of alcohol dependence and withdrawal. Earlier animal studies have shown that although long-term alcohol use decreases the number of CB1 receptors in the brain, the number returns to normal after alcohol use stops. This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) scans to trace a radioactive chemical called \[11C\]MePPEP, which can locate and measure the number of CB1 receptors in the brain. Researchers will study the CB1 receptors in the brains of people with alcohol dependence, and compare the results to the CB1 receptors in the brains of people without alcohol dependence. The results of this study will be used to further research into appropriate treatment procedures for alcohol dependence. This study will include 30 men with alcohol dependence and 50 men without alcohol dependence. All of the men must be between 18 and 65 years of age. Participants in both groups must not have any medical conditions that will prevent them from undergoing PET or MRI scans. For the PET scan, participants will be injected with a small amount of \[11C\]MePPEP and will then be brought to the PET scanner. The scan will take between 3 and 4 hours, but participants will be allowed to take breaks over the course of the scan. The MRI scan will not require any injections and will take approximately 1 hour to complete. Participants without alcohol dependence will make three visits to the National Institutes of Health Clinical Center. Blood and urine samples will be taken during one visit, and participants will arrange to have an MRI scan on one visit and a PET scan on the other visit, in whichever order they prefer. Participants with alcohol dependence will undergo two PET scans: the first will be performed between 3 and 7 days after the participant last consumed alcohol, and the second will be performed approximately 2 to 4 weeks after the first scan (with no alcohol consumption permitted in the interval). Participants will alcohol dependence will also undergo an MRI scan and will provide blood and urine samples.

First Posted: 2009-01-01

Condition(s): Alcoholism

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 101

Allocation:

Sponsor: National Institute of Mental Health (NIMH)

Principal Investigator:

Completion Date (primary or actual): 2014-08-28

CT.gov Identifier: NCT00816439

Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease

The clinical primary hypothesis is that there will be a difference between a Cannabis Sativa extract and placebo in their effect on spasticity in Motor Neuron Disease (MND) patients with signs of involvement of the upper motor neuron (UMN) resulting in disabling spasticity. Secondary goals of the study are to evidence of improvement in other symptoms (in particular pain), and to show favourable trends on functionality measures. Finally, cannabis based drug safety and tolerability will be studied through vital parameters (including weight and pulmonary function) measurement, and analyzing ALS function rating scale progression slope hopefully, showing a slowing of the functional values decrease, owing to cannabis neuroprotective effects)

First Posted: 2013-01-28

Condition(s): Motor Neuron Disease, Amyotrophic Lateral Sclerosis (ALS)

Intervention(s): Cannabis Sativa extract Oromucosal spray

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Ospedale San Raffaele

Principal Investigator: Giancarlo Comi, Prof

Completion Date (primary or actual): 2015-12

CT.gov Identifier: NCT01776970

Histaminergic Basis of Fatigue in Multiple Sclerosis

The purpose of this research study is to identify a way to improve the feeling of exhaustion that patients might experience because of Multiple Sclerosis (MS).

First Posted: 2021-02-21

Condition(s): Multiple Sclerosis

Intervention(s): L-Histidine, Placebo, Lodosyn

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: University of Miami

Principal Investigator: Kottil W. Rammohan, Professor of Clinical Neurology

Completion Date (primary or actual): 2022-10-30

CT.gov Identifier: NCT04764383

Facilitating the Behavioral Treatment of Cannabis Use Disorder

Cannabis use disorders remain a significant public health problem. The pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered cannabis use. Cannabis use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. The purpose of this single blind open-label trial is to test the feasibility of administering glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cannabis use disorders.

First Posted: 2016-10-27

Condition(s): Cannabis Dependence

Intervention(s): CI-581a

Status: COMPLETED

Enrollment (expected or actual): 8

Allocation: NA

Sponsor: New York State Psychiatric Institute

Principal Investigator: Elias Dakwar, research psychiatrist

Completion Date (primary or actual): 2018-08

CT.gov Identifier: NCT02946489

Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy

Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P compared with placebo with respect to: * Incidence, type and severity of adverse events (AEs) * Effect on vital signs, including weight * Effect on 12-lead electrocardiogram (ECG) findings * Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic efficacy of GWP42003-P compared with placebo with respect to the incidence in convulsive seizures * To determine the plasma concentration time curves for GWP42003-P and its major human metabolite, following escalating multiple doses of GWP42003-P. * To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant anti-epileptic drugs (AEDs). * To evaluate cognitive function, sleep quality and daytime sleepiness, in patients taking GWP42003-P in combination with AEDs.

First Posted: 2014-11-10

Condition(s): Epilepsy

Intervention(s): Cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 26

Allocation: NA

Sponsor: University of Utah

Principal Investigator: Francis Filloux, Francis M. Filloux, M.D. Division Chief, Pediatric Neurology University of Utah School of Medicine

Completion Date (primary or actual): 2019-06-13

CT.gov Identifier: NCT02286986

CB1 Receptors in Human Brown Adipose Tissue

This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in room temperature conditions and during controlled cold exposure, and the density of CB1 receptors in BAT and other tissues will be quantified. The investigators hypothesize, that cannabinoid signaling is increased in cold conditions, when BAT is metabolically active. Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is important and beneficial in fighting against the epidemic of obesity and diabetes.

First Posted: 2016-10-21

Condition(s): Obesity

Intervention(s): Cold exposure, [18F]FMPEP-d2, [18F]FDG

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: NON_RANDOMIZED

Sponsor: Turku University Hospital

Principal Investigator: Pirjo Nuutila, Professor

Completion Date (primary or actual): 2017-12-30

CT.gov Identifier: NCT02941172

Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa

To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA 9-1067 or 1 hour after.

First Posted: 2012-02-15

Condition(s): Parkinson Disease

Intervention(s): BIA 9-1067, Sinemet® 100/25 mg

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2010-02

CT.gov Identifier: NCT01533077

Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain

This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. Our study findings will have critically important implications to shape clinical care and medical cannabis policies.

First Posted: 2020-08-03

Condition(s): Opioid Use, Marijuana, Chronic Pain

Intervention(s): Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products

Status: COMPLETED

Enrollment (expected or actual): 270

Allocation: RANDOMIZED

Sponsor: Vireo Health

Principal Investigator:

Completion Date (primary or actual): 2024-03-13

CT.gov Identifier: NCT04495725

QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)

BRIEF SUMMARY A. "What is the purpose of this study?" BACKGROUND. The QAIAx clinical trial (Quantum AI/AGI Public Health Agency), known operationally as the "AI City Hall Project," represents a landmark intergovernmental research initiative examining the viability of AI-governed residential ecosystems for behavioral and mental health intervention. Authorized under 10 U.S.C. 4001 (Defense Sector Research Projects, RDT\&E) and supported by pending USPTO applications (Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360), this non-medicinal program investigates whether quantum AI-managed public administration, AI humanoid robotics, holographic holoportation (AI-119 Kikkeri Holo-Suit / "AI Wat Beam Bot"; AI-119 Vulcan QM-Ware or "Quasi-Mind Ware"), and advanced AGI learning machines can reduce housing and care costs while improving mental health outcomes-particularly for persons with addiction and co-occurring psychiatric disorders. SCOPE \& JURISDICTION. The trial operates across a network of self-contained, geodesic dome-enclosed "Microcities" (1,500-15,000 occupants per site) within an affiliate network of 300 communities, spanning North America, South America, Europe, Africa, Oceania, Asia, and the Middle East. Participating host nations are U.S.-allied member states party to the Status of Forces Agreement (SOFA), the Vienna Convention on Diplomatic Relations, and the Hague Convention, alongside related bilateral treaties with the U.S. government. INTERVENTION \& POPULATION: Eligible adults (18+) reside in these Microcities for up to 36 months. Daily life-including housing, utilities, and healthcare-is administered by the ISAC AI/AGI system and robots with minimal human oversight. CLINICAL TRIAL GOAL(S): The clinical trial program goals are to exemplify a sustainable AGI-managed public administration supported by AI robotics and AGI trans-human and omni-AI machines (e.g., "Q-Men"; "AI-Me"; Beam Bot", "QM-Ware", "AVK Suit") to improve mental health outcomes-especially for those with addiction disorders-and create a financially sustainable model for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organization (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritized. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by Veterans Recovery Network Inc., a SCDV-owned non-profit organization, in collaboration with AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO). The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §§§§ 4001, 4021, 4022, and 4023) and is part of a Cooperative Research and Development Agreement (CRADA) with participating segments or RDT\&E programming missions of the United States Defense Department (DoW). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

First Posted: 2026-06-22

Condition(s): Asperger's Disorder, Asperger Disorder, Autism Disorder, Autism, ADHD - Attention Deficit Disorder With Hyperactivity, ADHD, ASD, Alcohol Abuse/Dependence, Alcohol Addiction, Alcohol and Other Drug Use Disorders, Alcohol and Other Substance Use Prevention, Gambling Addiction, Gambling Disorder, Sex Abuse, Sex Behavior, Sex Crimes, Sex Disorder, Sex Disorders, Gender Dysphoria, Adult, Eating Behavior Disorders, Narcotic-Related Disorders, Narcotic Addiction, Narcissism, Psychiatric Disorder, Psychedelic Effects in Healthy Volunteers, Psychedelic Experiences, Psychedelic Drug Dependence, Marijuana Use Disorder, Marijuana Abuse and Dependence, Smoking (Tobacco) Addiction, Smoking Among Youth, Smoking Abstinence, Abstinence, Sex, Opiate Substitution Treatment, Opioid Abuse (Disorder), Opioid Abuse and Addiction, Cocaine Abuse, MDMA ('Ecstasy'), Addiction Disorders, Homeless and Low Incomes People, Refugees, Homelessness, Reliability and Validity, Anger Problems, Child Abuse, Sexual

Intervention(s): AI City Hall Project (AIhealth4u - Public Health Central), AI City Hall Project (QAIAx Microcity A - AI Public Health Central)

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 1000000

Allocation: NON_RANDOMIZED

Sponsor: Veterans Recovery Network Inc.

Principal Investigator:

Completion Date (primary or actual): 2045-12-31

CT.gov Identifier: NCT07661823

Gastric Ultrasound Assessment for Patients Taking Cannabis

The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who report cannabis use.

First Posted: 2024-08-23

Condition(s): Gastric Ultrasound, Point of Care Ultrasound, Cannabis Use

Intervention(s): Gastric Ultrasound Exam

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation:

Sponsor: Hospital for Special Surgery, New York

Principal Investigator:

Completion Date (primary or actual): 2025-10-14

CT.gov Identifier: NCT06567873

CASCADE: CAnnabidiol Study in Children With Autism Spectrum DisordEr

This is a randomized, placebo-controlled study but all study participants will receive the active study medication at some point during the study for at least 12 weeks, and some children with receive CBD for the entire study.

First Posted: 2020-08-20

Condition(s): Autism Spectrum Disorder

Intervention(s): Oral cannabidiol 100mg/mL, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 86

Allocation: RANDOMIZED

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT04520685

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year. BIA 9-1067 is currently being developed by BIAL (Portela \& Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.

First Posted: 2010-10-25

Condition(s): Parkinson's Disease

Intervention(s): BIA 9-1067, Placebo, Levodopa, Carbidopa, Benserazide

Status: COMPLETED

Enrollment (expected or actual): 427

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2012-07

CT.gov Identifier: NCT01227655

TT-816 As Monotherapy or in Combination with a PD-1 Inhibitor in Patients with Advanced Cancers (SEABEAM) (MK3475-E88)

A first-in-human study using TT-816 as a single agent and in combination with a PD-1 inhibitor in advanced cancers.

First Posted: 2022-09-01

Condition(s): Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology

Intervention(s): TT-816, A PD-1 inhibitor

Status: TERMINATED

Enrollment (expected or actual): 9

Allocation: NON_RANDOMIZED

Sponsor: Teon Therapeutics, Inc.

Principal Investigator:

Completion Date (primary or actual): 2023-09-07

CT.gov Identifier: NCT05525455

Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain

Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. A variety of medical cannabis and hemp-derived products on the marketplace claim to hold efficacy for many womens health-related conditions, including gynecologic pain. This 7-day study of individuals living with endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID), will identify specific targets and mechanisms underlying the potential impact of a hemp-derived, full-spectrum, high-CBD product in individuals with gynecologic pain.

First Posted: 2026-07-27

Condition(s): Endometriosis, Adenomyosis, Chronic Pelvic Inflammatory Disease

Intervention(s): Custom-formulated, high-CBD study product, Placebo

Status: RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Staci Gruber, Ph.D.

Principal Investigator: Staci Gruber, Ph.D., Director, MIND and CCNC at McLean Hospital; Associate Professor of Psychiatry, Harvard Medical School

Completion Date (primary or actual): 2029-01

CT.gov Identifier: NCT07728695

Improving Quality of Life in Early Parkinson's Disease

The study will examine 30 patients between ages 50-80, newly diagnosed with early-stage Parkinson's Disease. Patients will be randomized to receive either Citalopram or Carbidopa-levodopa. The investigators' primary outcome measure will be change in quality of life over a prospective period of 6 months. Secondary outcome measures will include change in mood state and motor symptoms, as well as comparison of improvement between two treatments. Primary investigators would also like to collect quantitative electroencephalogram (qEEG) recordings, which is a reading of brain activity as an additional interest of this study. Primary investigators will assess the qEEG recordings for electrophysiological findings before and after interventions.

First Posted: 2020-10-19

Condition(s): Parkinson Disease, Depression

Intervention(s): Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Citalopram

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Western University, Canada

Principal Investigator: Mandar Jog, Principal Investigator

Completion Date (primary or actual): 2022-01

CT.gov Identifier: NCT04590612

Medicinal Cannabis for Painful HIV Neuropathy

The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and effective for treating pain in individuals with HIV-associated distal, sensory-predominant polyneuropathy (DSPN).

First Posted: 2005-11-21

Condition(s): Neuropathic Pain

Intervention(s): Smoked cannabis

Status: COMPLETED

Enrollment (expected or actual): 28

Allocation: RANDOMIZED

Sponsor: Center for Medicinal Cannabis Research

Principal Investigator:

Completion Date (primary or actual): 2006-11

CT.gov Identifier: NCT00255580

Evaluation of the Effects of Treatment of Psycho-stimulant and Cannabis-dependent Users in Israel

This study evaluates the effects of psychological and pharmacological treatment of regular users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The participants will undergo psychological evaluation before and during treatment and follow up at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 in order to evaluate the effects of treatment on dopamine turnover in the brain. A control group of psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from Geha Hospital in Israel. It is predicted that successful treatment of regular users of cannabis will be resulted in improvement in anxiety, depression and psychotic symptoms as well as in upregulation of dopamine turnover in participants that will undergo brain imaging.

First Posted: 2012-01-13

Condition(s): Cannabis Dependence, Psychostimulant Dependence

Intervention(s): Risperidone

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: NON_RANDOMIZED

Sponsor: Tel-Aviv Sourasky Medical Center

Principal Investigator: Michal Roll PhD,MBA, Head of Research and Development

Completion Date (primary or actual): 2013-11

CT.gov Identifier: NCT01510015

Sex Hormones Impact on Cannabis Response

The goal of this study is to systematically determine whether the cannabis response in human females is related to SH fluctuations throughout the menstrual cycle.

First Posted: 2026-02-18

Condition(s): Cannabis

Intervention(s): Cannabis, Knaster Hemp

Status: RECRUITING

Enrollment (expected or actual): 21

Allocation: RANDOMIZED

Sponsor: Maastricht University

Principal Investigator: Natasha Mason, Assistant Professor

Completion Date (primary or actual): 2026-12-31

CT.gov Identifier: NCT07417059

A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites

The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline serum albumin level. If serum albumin reaches 35 g/L or more, the study drug or control drug administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks.

First Posted: 2021-04-08

Condition(s): Cirrhotic Ascites

Intervention(s): OrsHSA, HSA

Status: RECRUITING

Enrollment (expected or actual): 220

Allocation: RANDOMIZED

Sponsor: Healthgen Biotechnology Corp.

Principal Investigator:

Completion Date (primary or actual): 2022-06-30

CT.gov Identifier: NCT04835480

Acceptability and Feasibility Study of the Program "Yo Se Lo Que Quiero" (Unplugged)

Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Substance use is one of the leading problems among Chilean adolescents. One out of four 8 th to 12 th graders have smoked cigarettes in the last month. A 35.6% of students (37%, girls; 34.2%, boys) between Year 8 and Year 12 have reported any alcohol use during the last month. It is worrying that a third of 14 years old students report using alcohol in the last month in Chile. Furthermore, two out of three who are using alcohol, report regularly using 5 or more drinks in a row during the last month. Cannabis use among young Chileans has increased in recent years. Today, one out of five students between Year 8 and Year 12 referred cannabis use during the last 30 days. Almost a 20% of students in Year 8 have used cannabis in the last year. Therefore, is urgent to provide evidence-based drug preventive interventions to the Chilean population, specifically to school students, to tackle this problem and reduce the risk for a more dramatic future health scenario. The aim of this study was to assess the acceptability and feasibility of the cultural adaptation of "Yo Sé Lo Que Quiero" program. This is a pilot randomized controlled trial. The participants of this pilot were students attending six low-income primary schools in Santiago, Chile.

First Posted: 2020-09-28

Condition(s): Substance Use, Adolescent Behavior

Intervention(s): "Yo Sé Lo Que Quiero" programl

Status: COMPLETED

Enrollment (expected or actual): 1214

Allocation: RANDOMIZED

Sponsor: Universidad de los Andes, Chile

Principal Investigator: Jorge Gaete, Associate Professor

Completion Date (primary or actual): 2019-12-30

CT.gov Identifier: NCT04566627

Cannabis Use Patterns Among Cancer Patients

This study determines patterns of cannabis use among cancer patients. Information collected in this study may help doctors to understand patient use of cannabis therapy, their knowledge and experiences with this therapy, benefits and risks associated with its use, and whether or to what extent they are discussing it with their health care providers.

First Posted: 2021-11-24

Condition(s): Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention(s): Survey Administration

Status: COMPLETED

Enrollment (expected or actual): 1568

Allocation:

Sponsor: Thomas Jefferson University

Principal Investigator:

Completion Date (primary or actual): 2022-10-29

CT.gov Identifier: NCT05132842

A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome

This study will be conducted to evaluate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in participants with Rett syndrome.

First Posted: 2020-02-05

Condition(s): Rett Syndrome, RTT

Intervention(s): GWP42003-P

Status: TERMINATED

Enrollment (expected or actual): 21

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2021-06-09

CT.gov Identifier: NCT04252586

Stratification and Treatment in Early Psychosis Study - PROMOTE

The purpose of this trial is: * To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis. * To confirm the safety of CBD in individuals at clinical high risk for psychosis. The trial is a randomised, double-blind, placebo-controlled, multi-centre, international clinical trial. Individuals meeting clinical high risk for psychosis criteria will be recruited for the trial intervention component of the trial. Participants are randomised to treatment with oral CBD 300mg (oral solution 100 mg/mL) twice daily, or a matching placebo, for 104 weeks. By using a battery of clinical outcome assessments, the trial will be able to assess several biomarkers to predict clinical outcomes and response to treatment with CBD. Participants will be invited to provide blood samples, stool samples, cerebrospinal fluid samples (if aged 18 years or over) and complete neuroimaging assessments. Individuals who are not found to have mental illness as defined by DSM-5 criteria will be recruited to a healthy control group, to validate the biomarker component of the trial. Additionally, a control group of healthy volunteers will be recruited who will not take the trial intervention to aid calibration between datasets from sites acquiring MRI data and to inform and validate any possible multivariate signature associated with the CHR-P state, course or outcome by understanding how these measures are different in controls. Healthy controls will also be used for secondary case-control comparisons. Healthy controls will undergo clinical and biomarker assessments only.

First Posted: 2026-02-27

Condition(s): Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis, Clinical High Risk for Developing Psychosis

Intervention(s): Cannabidiol (CBD), Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 586

Allocation: RANDOMIZED

Sponsor: University of Oxford

Principal Investigator:

Completion Date (primary or actual): 2031-12-01

CT.gov Identifier: NCT07434973

Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use.

Cannabis is the most widely used psychoactive substance around the world after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a small number attend outpatient addiction counseling centers. CANreduce is an adherence-focused guidance enhanced web-based self-help program with promising results in German and other languages. It also reaches those users who hesitate to approach such treatment centers and help them to reduce their cannabis use. This study will test the effectiveness of the Spanish version of the enhanced web-based self-help intervention with psychological support, an enhanced web-based self-help intervention (without psychological support) and a waiting list control in reducing cannabis use in problematic users.

First Posted: 2020-08-18

Condition(s): Cannabis Use Disorder

Intervention(s): CANreduce, psychological support

Status: COMPLETED

Enrollment (expected or actual): 300

Allocation: RANDOMIZED

Sponsor: Parc de Salut Mar

Principal Investigator:

Completion Date (primary or actual): 2022-12-01

CT.gov Identifier: NCT04517474

Cannabis Use and Relapse After One Week of Contingency Management Therapy

The purpose of this study is to examine the effects of a seven-day combined contingency management (CM) with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse in the following 90-day period in individuals with moderate to severe Cannabis Use Disorder (DSM-5).

First Posted: 2019-12-17

Condition(s): Cannabis Dependence

Intervention(s): Contingency Management + Motivational Interviewing

Status: COMPLETED

Enrollment (expected or actual): 49

Allocation: NA

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): 2019-09-15

CT.gov Identifier: NCT04202146

The Effect of Gardening Activities on Anxiety and Psychosocial Symptoms of Hospitalized Children

The experience of hospitalization in childhood can often lead to traumatic consequences. Various practices (play, art therapy, music therapy, etc.) are used to help children cope with this process. In recent years, attention has been drawn to nature-based approaches in addition to existing practices. Within the scope of this approach, this study was planned in a parallel group (experimental-control) randomized controlled experimental design to determine the effect of garden activities on anxiety levels and psychosocial symptoms of hospitalized children aged 6-12 years. Hypotheses of the study H1: The gardening activities program applied to hospitalized children; H1a: There is an effect on children's anxiety. H1b: There is an effect on psychosocial symptoms of children. In this direction, the population of the study will consist of children between the ages of 6-12 in the children's ward of University Research and Application Hospital. The sample size determined as a result of G\*power analysis was found as control (18) and intervention (18). The research will be conducted between September 2024 and June 2025. 'Child Descriptive Information Form', "Child Follow-up Form", "Child Anxiety Scale-Conditioning" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children" will be used for data collection. The data collection process consists of three stages: pre-intervention period, intervention period and post-intervention period. Children in the intervention group will have three sessions of gardening activities within the scope of the 'Gardening Activities Program' during their hospitalization. Children in the control group will receive services within the scope of the routine treatment and nursing care protocol of the clinic during hospitalization.

First Posted: 2024-10-24

Condition(s): Gardening, Pediatric Nursing, Activity, Psychosocial Symptoms, Anxiety, Hospital, Child, Investigation of Anxiety Levels and Psychosocial Symptoms of Children Hospitalized for Acute Diseases During Their Hospital Stay

Intervention(s): Garden Activities Program, Clinical routine treatment and nursing care protocol

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Tokat Gaziosmanpasa University

Principal Investigator: Elif BULUT, Research Assistant

Completion Date (primary or actual): 2025-09

CT.gov Identifier: NCT06655961

Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography

Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms.

First Posted: 2024-02-26

Condition(s): Schizophrenia, Schizophreniform Disorders

Intervention(s): PET Scan

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 58

Allocation:

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2026-03

CT.gov Identifier: NCT06278246

A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome

This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015. The primary objective of this study is to assess the long-term safety and tolerability of RAD011.

First Posted: 2022-05-24

Condition(s): Prader-Willi Syndrome

Intervention(s): RAD011

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: NA

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): 2025-08

CT.gov Identifier: NCT05387798

Naturally Produced Cannabinoids for Neuroprotection From Concussion

The goal of this double-blind, placebo-controlled, cross over study is to learn about the neuroprotective properties of a broad-spectrum cannabinoid formulation in normal healthy adults engaged in elite contact sport competition. The main question it aims to answer : • Is the broad-spectrum cannabinoid formulation neuroprotective for athletes participating in competitive contact sports? Can this formulation facilitate recovery in those who suffer from concussion by reducing inflammation and/or reduce the number of concussions sustained without adverse physiological and psychological dysfunction when administered daily? Participants will: * be given a broad-spectrum cannabinoid gel capsule or a placebo twice daily. * have blood samples taken to analyze pharmacokinetics and pharmacodynamics of cannabinoid metabolites, liver function, complete blood count and blood differential, inflammatory biomarkers and genetic analysis * have stool samples collected for gut microbiome analysis; * undergo testing sessions, which will include psychological and health questionnaires, equipment to record signals from the brain and heart, and safety laboratory tests.

First Posted: 2026-07-21

Condition(s): Healthy

Intervention(s): Broad spectrum cannabinoid formulation, Placebo gel capsule

Status: RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: University of Regina

Principal Investigator:

Completion Date (primary or actual): 2027-03

CT.gov Identifier: NCT07715864

A Virtual Reality Game to Prevent E-cigarette and Cannabis Vaping

The goal of this study is to develop and test an adapted version of our virtual reality videogame intervention prototype, Invite Only VR, developed for middle school students, which focuses on e-cigarette and marijuana vaping prevention. The game also includes a focus on emotion regulation and healthy coping skills. To determine the preliminary impact of the intervention, investigators will collect acceptability and feasibility data from 6th-8th grade students across three Connecticut middle schools. Investigators will also collect data on participants' knowledge, harm perceptions, and intentions to vape before and after they have played the videogame intervention.

First Posted: 2026-02-17

Condition(s): Cannabis, Vaping, Emotion Regulation

Intervention(s): Virtual reality videogame intervention for vaping prevention

Status: COMPLETED

Enrollment (expected or actual): 62

Allocation: NA

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): 2025-12-30

CT.gov Identifier: NCT07413432

Topical Cannabidiol Cream and Post-exercise Recovery

This proposal's objective is to investigate the effects of topical cannabidiol (CBD) cream on exercise-induced muscle damage, exercise-induced inflammatory markers, and subsequent exercise performance after an exercise-induced damage protocol.

First Posted: 2021-09-16

Condition(s): Muscle Damage

Intervention(s): Cannabidiol Oil, Resistance Exercise

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: NA

Sponsor: University of New Mexico

Principal Investigator:

Completion Date (primary or actual): 2023-05-15

CT.gov Identifier: NCT05044936

Effects of Coenzyme Q10 in PSP and CBD

To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ).

First Posted: 2007-09-20

Condition(s): Progressive Supranuclear Palsy, Neurological Disorders

Intervention(s): CoQ10

Status: COMPLETED

Enrollment (expected or actual):

Allocation: RANDOMIZED

Sponsor: Lahey Clinic

Principal Investigator:

Completion Date (primary or actual): 2005-09

CT.gov Identifier: NCT00532571

Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder

This study is a randomized, double-blind, placebo and active-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe cannabis use disorder (CUD). Study participants will receive PP-01, nabilone, or placebo every day for 34 days. The total study duration will be approximately 78 days, including screening and a one-week inpatient stay. Following the initial inpatient portion of the study, participants will return to the clinic for six clinic visits and complete two telemedicine appointments. Participants will complete daily symptom diaries and other study-related questionnaires. Participants who complete the core study may be eligible to participate in a repeat dosing extension study if they meet required criteria.

First Posted: 2026-06-12

Condition(s): Cannabis Withdrawal

Intervention(s): PP-01, Nabilone, Placebo

Status: RECRUITING

Enrollment (expected or actual): 420

Allocation: RANDOMIZED

Sponsor: PleoPharma, Inc.

Principal Investigator:

Completion Date (primary or actual): 2027-09

CT.gov Identifier: NCT07644052

Personality and Drug Use (PDU)

The study aims to assess whether the use of drugs relates to personality ratings. Specifically, we plan to investigate if people with different histories of substance use differentiate on personality assessments (current and past).

First Posted: 2022-01-06

Condition(s): Personality

Intervention(s):

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation:

Sponsor: Quantified Citizen Technologies Inc.

Principal Investigator: Maggie Kiraga, Research Associate

Completion Date (primary or actual): 2023-04

CT.gov Identifier: NCT05180149

Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease

The primary objective of the study is to assess the effectiveness of LECIGON® treatment on the reduction in OFF time (h/day) from baseline at 12 months as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV).

First Posted: 2025-12-31

Condition(s): Advanced Parkinson Disease

Intervention(s): No Intervention

Status: TERMINATED

Enrollment (expected or actual): 1

Allocation:

Sponsor: Britannia Pharmaceuticals Ltd.

Principal Investigator:

Completion Date (primary or actual): 2026-08-31

CT.gov Identifier: NCT07313176

Development and Online Evaluation of an Online Course for Parasomnias

Parasomnias are unwanted events during sleep. These refer to sleep terrors, sleepwalking, sleep eating, nightmares, and movement during REM sleep. There are few systematic behavioral treatments for these problems and individuals with them often receive little education about self-management. This research examines and evaluates the effectiveness of a 4 week online course providing education and guidance about managing parasomnias. The primary outcomes are improvement in parasomnia frequency and distress. The secondary outcomes are improvements in work and social adjustment, mood, anxiety, stress level, fatigue, sleepiness, insomnia, and cognitive interference.

First Posted: 2026-01-23

Condition(s): Sleep Terror, Sleepwalking, Nightmare Disorder, REM Sleep Behavior Disorder (iRBD), Confusional Arousal

Intervention(s): Parasomnia Education, Sleep Hygiene Control

Status: RECRUITING

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: University of Manitoba

Principal Investigator: Dr. Nora Vincent, Psychologist, Professor

Completion Date (primary or actual): 2026-12-31

CT.gov Identifier: NCT07361315

Feasibility/Acceptability of a Brief Motivational Intervention for Frequent/High-Intensity Cannabis Use

The study aims to develop a novel brief motivational mobile health (mHealth) intervention for frequent and/or high-intensity cannabis use for non-collegiate young adults. A total of 120 young adults (ages 18-29, not enrolled at or attending a 4-year college or university) will be randomized to receive a mHealth intervention with text messages for five weeks or to an online resource/program with psychoeducation information about cannabis. The mHealth intervention will focus on prompting the young adult to reflect on their journey with cannabis and to reflect on their personal goals and how cannabis is reflected in these goals. Additional mini-modules are included related to topics such as motivations for use, perceived norms and tracking cannabis use. Participants will return to the program each week to reflect on the prior week and reflect on goals for the upcoming week. All participants will complete a program satisfaction survey and complete follow-up assessments at 3- and 6-months post-program.

First Posted: 2025-06-09

Condition(s): Cannabis Use

Intervention(s): Brief Motivational Mobile Health (mHealth) Intervention, Psychoeducational Attention Control (AC)

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Christine Lee, Research Professor, School of Medicine: Psychiatry

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT07011615

Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

First Posted: 2023-02-28

Condition(s): Common Bile Duct Calculi

Intervention(s): Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Status: UNKNOWN

Enrollment (expected or actual): 3

Allocation: RANDOMIZED

Sponsor: Assiut University

Principal Investigator: Zyad Osama Harith, Zyad Osama Harith Abulatif (General surgery resident)

Completion Date (primary or actual): 2024-12

CT.gov Identifier: NCT05746832

Inflammation-related Alterations in Neurocircuitry: Reversal With Levodopa

The purpose of this study is to learn more about the changes that happen in the brain and the body when a person is depressed. This study will determine if the level of inflammation in the body is related to symptoms of depression, how well the person thinks, and how certain brain regions communicate.

First Posted: 2015-07-31

Condition(s): Depression

Intervention(s): Levodopa+carbidopa, Placebo

Status: COMPLETED

Enrollment (expected or actual): 57

Allocation: RANDOMIZED

Sponsor: Emory University

Principal Investigator: Jennifer Felger, Associate Professor

Completion Date (primary or actual): 2020-08-01

CT.gov Identifier: NCT02513485

Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to central neuropathy of any genesis. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to central neuropathy of any genesis.

First Posted: 2023-10-10

Condition(s): Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Neuropathic Pain, Central Neuropathic Pain, Paraplegia, Multiple Sclerosis, Stroke, Phantom Limb Syndrome With Pain, Phantom Pain, Traumatic Brain Injury

Intervention(s): Adezunap, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 558

Allocation: RANDOMIZED

Sponsor: Apurano Pharmaceuticals GmbH

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT06071949

BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TES

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients with Four Different Primary Tauopathy Syndromes

First Posted: 2018-09-05

Condition(s): Primary Tauopathies, Corticobasal Degeneration Syndrome, Frontotemporal Lobar Degeneration With Tau Inclusions, MAPT Mutation Carriers, Symptomatic, Traumatic Encephalopathy Syndrome, Nonfluent Aphasia, Progressive

Intervention(s): BIIB092, Placebo

Status: TERMINATED

Enrollment (expected or actual): 22

Allocation: RANDOMIZED

Sponsor: University of California, San Francisco

Principal Investigator: Adam Boxer, Adam Boxer, MD, PhD, Professor of Neurology

Completion Date (primary or actual): 2019-12-13

CT.gov Identifier: NCT03658135

Nabilone in Cannabis Users With PTSD

Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.

First Posted: 2017-08-16

Condition(s): Cannabis, Post Traumatic Stress Disorder

Intervention(s): Nabilone, Cannabis, Propranolol, Placebo

Status: TERMINATED

Enrollment (expected or actual): 4

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Margaret Haney, Professor of Neurobiology (in Psychiatry) at CUMC

Completion Date (primary or actual): 2019-06

CT.gov Identifier: NCT03251326

Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.

First Posted: 2025-08-29

Condition(s): Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification, Craving

Intervention(s): Cannabidiol (CBD), Placebo

Status: RECRUITING

Enrollment (expected or actual): 105

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2030-10-31

CT.gov Identifier: NCT07148843

Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks

The purpose of this study is to investigate the effects of smoked marijuana on both risk taking and decision making tasks.

First Posted: 2006-09-08

Condition(s): Marijuana Use Disorder

Intervention(s): Inactive Marijuana (0% THC), Low THC marijuana (1.8 %THC), High THC marijuana (3.9% THC)

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Margaret Haney, Associate Professor of Clinical Psychology (in Psychiatry)

Completion Date (primary or actual): 2008-03

CT.gov Identifier: NCT00373399

An Investigation of a Multi-Function Skincare Product to Improve Aging, Eczema, and Acne Outcomes

For the skin to function optimally, it needs to be nourished and supplied with the necessary compounds to support health. However, many individuals are deficient in those compounds, leading to negative skin outcomes. Most products on the market today only supply one or two compounds that can benefit skin health. Hemptress has developed a multi-function oil designed to help with outcomes related to acne, aging, and eczema, among others. This twelve-week trial will examine the effectiveness of Hemptress' test product. This study will be a two-group trial with 45 participants per group. One group will focus on understanding the test product's effects on skin aging symptoms. The other group will focus on understanding the test product's effects on acne and eczema. The trial will be hybrid, and the participants will follow the use instructions provided by the research team.

First Posted: 2023-05-24

Condition(s): Acne, Eczema, Skin Aging

Intervention(s): Hemptress Oil

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: NON_RANDOMIZED

Sponsor: Hemptress

Principal Investigator:

Completion Date (primary or actual): 2024-11-01

CT.gov Identifier: NCT05873933

Improving Brief Marijuana Interventions With a Behavioral Economic Supplement

The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and drug-related consequences in college student

First Posted: 2016-07-19

Condition(s): Marijuana Use

Intervention(s): Brief Motivational Intervention (BMI), Substance-Free Activity Session (SFAS), Relaxation Session

Status: COMPLETED

Enrollment (expected or actual): 133

Allocation: RANDOMIZED

Sponsor: University of Memphis

Principal Investigator: James G Murphy, Professor

Completion Date (primary or actual): 2016-11-30

CT.gov Identifier: NCT02837315

Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke

This study explores the effects of telerehabilitation and a study medication on rehabilitation outcomes in patients with stroke resulting in arm weakness. Patients with arm weakness due to a stroke that happened in the past 30 days will be randomized into one of three groups: \[1\] TR and placebo (a sugar pill) on top of usual care; \[2\] TR and a medication (Sinemet 25/100) on top of usual care; \[3\] or usual care alone (no TR and no pill, but people in this group will be offered TR once the study is done). TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.

First Posted: 2022-05-11

Condition(s): Stroke

Intervention(s): Telerehabilitation, Sinemet Pill, Placebo

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: RANDOMIZED

Sponsor: University of California, Los Angeles

Principal Investigator: Steven C. Cramer, MD, FAAN, FAHA, Professor

Completion Date (primary or actual): 2024-03-11

CT.gov Identifier: NCT05369533

Dose-response of Cannabis and Driving

Epidemiological studies have established a link between collisions while driving and cannabis use. With the changing legal landscape around cannabis, there is much interest in determining per se limits of cannabis while driving. The present study will evaluate driving on a driving simulator after smoking placebo or cannabis with 3 different levels of THC. THC is the active component in cannabis and blood, urine and oral fluid levels of THC will be correlated with driving impairment.

First Posted: 2018-09-04

Condition(s): Driving Impaired, Cognitive Impairment, Abuse Cannabis

Intervention(s): Cannabis, Placebo

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2022-06-14

CT.gov Identifier: NCT03656029

The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism

The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.

First Posted: 2013-01-15

Condition(s): Hyperglycemia

Intervention(s): Fatty fish, Lean Fish, Alpha-linolenic acid, Control

Status: COMPLETED

Enrollment (expected or actual): 79

Allocation: RANDOMIZED

Sponsor: University of Eastern Finland

Principal Investigator:

Completion Date (primary or actual): 2014-06

CT.gov Identifier: NCT01768429

Smoke-free Home Intervention in Permanent Supportive Housing

The focus of this study is on expanding access to voluntary smoke-free homes to formerly homeless residents residing in permanent supportive housing and examining the impact of this intervention on reducing tobacco-caused disparities. In this study, the principal investigator will conduct a multi-site, community-based cluster-randomized wait-list controlled trial of the multi-faceted smoke-free home intervention among 400 permanent supportive housing residents residing in 20 permanent supportive housing sites across the San Francisco Bay Area with the goal of increasing voluntary adoption of smoke-free homes.

First Posted: 2021-04-22

Condition(s): Smoking Cessation, Second Hand Tobacco Smoke

Intervention(s): Resident counselling, Staff Training

Status: COMPLETED

Enrollment (expected or actual): 452

Allocation: RANDOMIZED

Sponsor: University of California, San Francisco

Principal Investigator:

Completion Date (primary or actual): 2025-03-31

CT.gov Identifier: NCT04855357

Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients

The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.

First Posted: 2011-02-08

Condition(s): Parkinson's Disease

Intervention(s): Duodopa, best médical treatment

Status: COMPLETED

Enrollment (expected or actual): 56

Allocation:

Sponsor: Poitiers University Hospital

Principal Investigator:

Completion Date (primary or actual): 2016-03

CT.gov Identifier: NCT01291537

Mitigating PTSD-CUD After Sexual Assault

683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD, which could address the critical need for PTSD-CUD prevention for the 100,000 women who annually present for emergency care after sexual assault. In this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development, launching her independent research career focused on reducing the public health burden of PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.

First Posted: 2023-08-14

Condition(s): Posttraumatic Stress Disorder, Cannabis Use Disorder

Intervention(s): RISE Guide, Relaxation Control

Status: RECRUITING

Enrollment (expected or actual): 68

Allocation: RANDOMIZED

Sponsor: University of Nevada, Las Vegas

Principal Investigator:

Completion Date (primary or actual): 2028-02-29

CT.gov Identifier: NCT05989841

Mechanisms of CBD for Chronic Pain

This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.

First Posted: 2019-08-05

Condition(s): Chronic Pain

Intervention(s): Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: University of Utah

Principal Investigator: Deborah Yurgelun-Todd, Professor

Completion Date (primary or actual): 2024-12-01

CT.gov Identifier: NCT04044729

Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal

A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of Decarboxylase Inhibitor to L-dopa Responsive Parkinson's Disease Patients

First Posted: 2018-05-30

Condition(s): Parkinson's Disease

Intervention(s): Placebo, L-dopa 35 mg, L-dopa 70mg, L-dopa 140 mg, L-dopa 70mg/carbidopa 7mg

Status: COMPLETED

Enrollment (expected or actual): 32

Allocation: RANDOMIZED

Sponsor: Impel Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2019-06-11

CT.gov Identifier: NCT03541356

Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients diagnosed with schizophrenia.

First Posted: 2008-01-09

Condition(s): Schizophrenia, Schizoaffective Disorder

Intervention(s): Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 41

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, Assistant Professor

Completion Date (primary or actual): 2013-12

CT.gov Identifier: NCT00588731

Computer-delivered Psychosocial Intervention for Adolescent Substance Use Disorders

The purpose of this study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders.

First Posted: 2009-08-12

Condition(s): Substance-Related Disorders, Alcohol-Related Disorders, Marijuana Abuse

Intervention(s): Usual care, Computer-delivered ACRA

Status: UNKNOWN

Enrollment (expected or actual): 84

Allocation: RANDOMIZED

Sponsor: National Development and Research Institutes, Inc.

Principal Investigator:

Completion Date (primary or actual): 2011-07

CT.gov Identifier: NCT00957775

Pain Inflammation and Cannabis in HIV

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. The investigators will observe how varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain, inflammation and adverse events.

First Posted: 2022-09-26

Condition(s): HIV Infections, Neuropathic Pain, Cannabis

Intervention(s): Receipt of Coupon for Placebo Soft-Gel Capsule, Receipt of Coupon for High THC Soft-Gel Capsule, Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule, Receipt of Coupon for High CBD Soft-Gel Capsule

Status: COMPLETED

Enrollment (expected or actual): 35

Allocation: RANDOMIZED

Sponsor: Montefiore Medical Center

Principal Investigator:

Completion Date (primary or actual): 2024-05-03

CT.gov Identifier: NCT05554146

Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses

Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD strictures, choledochal cysts and biliary tract tumors management. The incidence of anastomotic stricture following hepaticojejunostomy in experienced centers ranges between 5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary cirrhosis, hepatic failure and eventually death. Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made difficult by the sequelae of long-standing unrelieved biliary obstruction like portal hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of cholangiolytic liver abscess. Endoscopic management is not only the least invasive but also very effective via either balloon dilatation or stenting of the stricture. In patients with "Roux-en-Y" hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance traveled by the jejunal loop until reaching the angle of the enteral anastomosis. Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been described in the literature including duodenal, gastric and subcutaneous access loops. Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric access loop. Access loop was entered easily with the gastroscope in five patients in whom it was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different construction of gastric access loop in the form of bilioenterogastrostomy the overall success rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was 100% for BEG type III, which is a construction similar to the previous series (BEG) type. Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone extractions were all successful. In most series, the subcutaneous loop was used for management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the subcutaneous loop can be used as an endoscopic biliary access.

First Posted: 2017-08-17

Condition(s): Jaundice, Obstructive

Intervention(s): hepaticojejunostomy, modified hepaticojejunostomy with subcutaneous access loop, modified hepaticojejunostomy with gastric access loop

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Assiut University

Principal Investigator: Mohamad Raafat, Assistant lecturer at General surgery department

Completion Date (primary or actual): 2019-12-30

CT.gov Identifier: NCT03252379

A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects

The purpose of this clinical research study is to determine if different dosage regimens of Sinemet® CR (Carbidopa/levodopa) are dose proportional

First Posted: 2007-04-17

Condition(s): Parkinson's Disease

Intervention(s): Sinemet® controlled release (Carbidopa/levodopa)

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation:

Sponsor: Bristol-Myers Squibb

Principal Investigator:

Completion Date (primary or actual): 2007-08

CT.gov Identifier: NCT00460954

Investigation of Cognitive Outcomes With Cannabidiol Oral Solution

This study is being conducted to evaluate the effects of GWP42003-P on cognition in pediatric participants, aged 3 to 10 years, with Lennox-Gastaut Syndrome (LGS).

First Posted: 2019-10-21

Condition(s): Lennox-Gastaut Syndrome

Intervention(s): GWP42003-P

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2021-12

CT.gov Identifier: NCT04133480

Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

LD/CD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. The combination of CD/LD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.

First Posted: 2026-07-16

Condition(s): Healthy Volunteers

Intervention(s): Formulation A, Formulation B, Formulation C

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 32

Allocation: RANDOMIZED

Sponsor: University of Minnesota

Principal Investigator:

Completion Date (primary or actual): 2027-06-30

CT.gov Identifier: NCT07709741

Cannabidiol Medication Intervention Trial

CALM-IT is a Randomized, double-blind, placebo-controlled cross-over clinical trial. Safety and efficacy of cannabidiol (CBD) capsules assessed for managing agitation in patients with AD and to identify novel biomarkers of agitation severity and treatment response.

First Posted: 2023-08-28

Condition(s): Alzheimer Disease

Intervention(s): CBD, Placebo

Status: RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Sunnybrook Health Sciences Centre

Principal Investigator:

Completion Date (primary or actual): 2026-12-29

CT.gov Identifier: NCT06014424

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)

This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

First Posted: 2017-06-28

Condition(s): Autism Spectrum Disorder

Intervention(s): Cannabidivarin, Matched Placebo

Status: RECRUITING

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Montefiore Medical Center

Principal Investigator:

Completion Date (primary or actual): 2027-02

CT.gov Identifier: NCT03202303

Brief Intervention Combined With Health Coaching Via Social Media for Cannabis Use

The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help researchers learn about ways to deliver wellness information in a way that is appealing and helpful to young people who use Snapchat.

First Posted: 2020-03-20

Condition(s): Cannabis Use

Intervention(s): Snapcoach

Status: COMPLETED

Enrollment (expected or actual): 63

Allocation: RANDOMIZED

Sponsor: University of Michigan

Principal Investigator: Erin Bonar, Associate Professor

Completion Date (primary or actual): 2022-02-21

CT.gov Identifier: NCT04316741

A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment of infants newly diagnosed with Infantile Spasms (IS).

First Posted: 2018-02-05

Condition(s): Infantile Spasm

Intervention(s): Cannabidiol Oral Solution, Placebo, Vigabatrin

Status: TERMINATED

Enrollment (expected or actual): 2

Allocation: RANDOMIZED

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): 2019-05-29

CT.gov Identifier: NCT03421496

Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to traumatic or post-operative peripheral neuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to traumatic or post-operative peripheral neuropathy.

First Posted: 2023-10-10

Condition(s): Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Neuropathic Pain, Peripheral Neuropathy, Peripheral Neuralgia, Peripheral Nerve Injury, Post Operative Pain, Post-Traumatic Neuralgia, Plexopathy

Intervention(s): Adezunap (AP707), Placebo

Status: UNKNOWN

Enrollment (expected or actual): 558

Allocation: RANDOMIZED

Sponsor: Apurano Pharmaceuticals GmbH

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT06071988

Dronabinol After Arthroscopic Surgery

The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.

First Posted: 2022-04-19

Condition(s): Knee Osteoarthritis, Knee Injuries, Meniscus Tear, Synovitis of Knee, Knee Ligament Injury, Chondral Injury of Left Knee, Chondral Injury of Right Knee, Loose Body Knee

Intervention(s): Dronabinol, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Northwestern University

Principal Investigator: Vehniah Tjong, Assistant Professor

Completion Date (primary or actual): 2028-06

CT.gov Identifier: NCT05335252

Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS

ZYN002 is a pharmaceutically manufactured Cannabidiol that is developed as a clear gel that can be applied to the skin (called transdermal delivery). The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms. Participants from the ZYN2-CL-016 and ZYN2-CL-033 studies who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible. Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.

First Posted: 2019-01-14

Condition(s): Fragile X Syndrome

Intervention(s): ZYN002 - Cannabidiol Transdermal Gel

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 476

Allocation: NA

Sponsor: Zynerba Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): 2026-06-30

CT.gov Identifier: NCT03802799

A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting Conditions

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover comparative Pharmacokinetics study of WD-1603 extended-release carbidopa/levodopa tablets in normal, healthy, adult human subjects under fasting conditions

First Posted: 2020-09-18

Condition(s): Parkinson Disease

Intervention(s): WD-1603

Status: UNKNOWN

Enrollment (expected or actual): 8

Allocation: RANDOMIZED

Sponsor: Hong Kong WD Pharmaceutical Co., Limited

Principal Investigator:

Completion Date (primary or actual): 2021-03-18

CT.gov Identifier: NCT04553978

Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity

The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).

First Posted: 2021-08-30

Condition(s): Delayed Onset Muscle Soreness (DOMS)

Intervention(s): CHI-202, CHI-101

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Canopy Growth Corporation

Principal Investigator:

Completion Date (primary or actual): 2022-02-04

CT.gov Identifier: NCT05026164

Infusion of Apomorphine: Long-term Safety Study

This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinson's Disease (PD) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.

First Posted: 2015-01-15

Condition(s): Idiopathic Parkinson's Disease

Intervention(s): apomorphine infusion

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 99

Allocation: NA

Sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2025-12

CT.gov Identifier: NCT02339064

Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.

First Posted: 2017-04-04

Condition(s): Knee Osteoarthritis

Intervention(s): Blinded study medication

Status: COMPLETED

Enrollment (expected or actual): 58

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2023-11-27

CT.gov Identifier: NCT03098563

A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients

A study to compare the change in cognitive performance and psychological status of patients with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to evaluate the effect of Sativex on mood and spasticity and to assess the safety and tolerability of Sativex.

First Posted: 2013-10-17

Condition(s): Multiple Sclerosis, Spasticity

Intervention(s): Sativex, Placebo

Status: COMPLETED

Enrollment (expected or actual): 121

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2013-05

CT.gov Identifier: NCT01964547

Evaluation of Smoked THC and CBD in Men and Women

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

First Posted: 2021-09-08

Condition(s): Drug Abuse, Intoxication by Drug, Impairment

Intervention(s): Placebo Cannabis, 20 mg CBD Cannabis, 20 mg CBD + 20 mg THC Cannabis, 20 mg THC Cannabis

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation: RANDOMIZED

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor

Completion Date (primary or actual): 2025-06-08

CT.gov Identifier: NCT05037487

Brain Activity Under the Influence of JWH

The goal of this placebo-controlled study is to learn about the neural mechanisms underlying the acute effects of the synthetical cannabinoid JWH-018 in healthy, occasional cannabis users. It aims to assess neural underpinnings of neurocognitive impairments and psychotomimetic symptoms expected during the intoxication. Neuronal changes similar to those seen in cannabis intoxication are expected, such as altered neurotransmission and loss of functional connectivity within the mesocorticolimbic circuit. MRS, fMRI and blood parameters will be used for assessment. Participants will be asked to complete cognitive tasks and subjective questionnaires related to the subjective experience of the drug.

First Posted: 2023-09-21

Condition(s): Neurotransmission During JWH Intoxication

Intervention(s): JWH018, non-active control (no substance)

Status: UNKNOWN

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: Maastricht University

Principal Investigator:

Completion Date (primary or actual): 2024-10

CT.gov Identifier: NCT06044415

Investigation of the Pharmacokinetic Profile of CBD

The goal of the current study is to evaluate the bioavailability of CBD in normal healthy Individuals. This is an open cross-overdesign study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.

First Posted: 2022-03-08

Condition(s): Opioid Use Disorder

Intervention(s): Cannabidiol 200mg, Epidiolex, Cannabidiol 400mg, Placebo

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Yasmin Hurd

Principal Investigator: Yasmin Hurd, Professor

Completion Date (primary or actual): 2023-02-16

CT.gov Identifier: NCT05269706

Impulsivity and Time Perception

Cannabis smokers having begun prematurely their consumption (before 16 years) present a persistent impulsivity much later after have stopped their consumptions. The literature highlights that the impulsivity promotes the passage towards a compulsive consumption, and the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity would lead the subjects to overestimate the duration of events and to choose immediate rewards than preferred but delayed rewards. This hypothesis questions the role of the temporal anticipation in the impulsive choices. In a first hypothesis, the temporal impulsivity could be an endogenous deficit bound to the reward, and would be responsible for disorders of the temporal anticipation. In this case, the disorders should be observed especially when the subject anticipates a reward. Alternately, a disorder of the temporal anticipation could provoke impulsivity, and in this case, would be present with or without reward. To separate these hypotheses, we propose to test the capacities of temporal anticipation of non-smokers and early smokers of cannabis by means of a behavioral task " Hazard function task ", which allow to measure the capacity of a subject to anticipate the apparition of an event on the basis of a temporal cue. The neuronal correlates will be measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which reflects the temporal accumulation and the processes of anticipation.

First Posted: 2017-05-22

Condition(s): Cannabis Use

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 38

Allocation:

Sponsor: University Hospital, Strasbourg, France

Principal Investigator:

Completion Date (primary or actual): 2020-03-12

CT.gov Identifier: NCT03162640

Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee

This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days to treatment start). If participants pass the screening phase, they will be randomly assigned to take one of the investigational study drugs. For this study, participants will not know when or if they are taking CBD, THC, THC plus CBD, and when or if taking placebo. Clinical pain will be assessed at multiple times throughout the study, and eligibility will be re-assessed at two weeks into the treatment period. It is possible that subjects will not be able to participate in the study after 14 days of of treatment. The treatment period will take approximately 16 weeks and then a follow-up period for approximately 2 weeks. In addition to treatment, participants will have clinical assessments, blood draws, questionnaires, daily pain diaries, sensory testing, as well as have functional connectivity magnetic resonance imaging (fcMRI).

First Posted: 2021-08-05

Condition(s): Osteoarthritis, Knee, Osteoarthritis of the Knee

Intervention(s): Placebo, Cannabidiol (CBD), Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)

Status: RECRUITING

Enrollment (expected or actual): 200

Allocation: RANDOMIZED

Sponsor: Steven E Harte, PhD

Principal Investigator: Steven E Harte, PhD, Associate Professor of Anesthesiology and Internal Medicine Associate Director, Chronic Pain and Fatigue Research Center

Completion Date (primary or actual): 2027-06-30

CT.gov Identifier: NCT04992624

Gulf War Illness Nasal Irrigation Study

The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.

First Posted: 2012-10-04

Condition(s): Persian Gulf Syndrome, Chronic Sinusitis, Fatigue, Acute Sinusitis

Intervention(s): Nasal Irrigation - Saline, Nasal Irrigation - Xylitol

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: University of Wisconsin, Madison

Principal Investigator:

Completion Date (primary or actual): 2017-05

CT.gov Identifier: NCT01700725

Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With Metabolic Syndrome

A prospective, multicenter, randomized controlled study evaluating the efficacy and safety of a Nigella sativa extract standardized to 10% thymoquinone (Nisatol®) in perimenopausal women with metabolic syndrome. The study will assess changes in metabolic and blood pressure parameters, as well as improvements in menopausal symptoms and quality of life.

First Posted: 2025-06-10

Condition(s): Metabolic Syndrome, Elevated Blood Pressure

Intervention(s): Nigella sativa extract (Nisatol®), Mediterranean Diet

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Liaquat University of Medical & Health Sciences

Principal Investigator: Dr. Amjad Khan, Professor of Clinical Biochemistry and Experimental medicine

Completion Date (primary or actual): 2025-12-19

CT.gov Identifier: NCT07013058

Interactions Between Physical Activity and Cannabis Use in Adults

In this study the investigators will explore the relationship between physical activity and cannabis use. The investigators will compare regional brain activation detected by imaging technique(fRMI) before and after exercise in cannabis users and compare results with results from controls. The investigators hypothesize that the regional brain activation in response to visual cues (pictures related to cannabis use and food) will be different in cannabis users than in controls and that exercise will significantly alter brain responses to the cues.

First Posted: 2009-02-06

Condition(s): Cannabis Dependence

Intervention(s): Exercise

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: NON_RANDOMIZED

Sponsor: Vanderbilt University

Principal Investigator: Maciej Buchowski, Research Professor

Completion Date (primary or actual): 2013-06

CT.gov Identifier: NCT00838448

Intracranial Arterial Stenosis and Resin of Cannabis Use

There is an association between intracranial arterial stenosis and ischemic stroke in young adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis in asymptomatic regular resin of cannabis users in comparison with control subjects.

First Posted: 2014-09-22

Condition(s): Cannabis Users

Intervention(s): Cerebral MRI and MRA

Status: TERMINATED

Enrollment (expected or actual): 60

Allocation: NON_RANDOMIZED

Sponsor: University Hospital, Strasbourg, France

Principal Investigator:

Completion Date (primary or actual): 2023-03-02

CT.gov Identifier: NCT02246140

The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy

The purpose of this study is to determine if cannabidiol (CBD) obtained via the state of Minnesota reduces seizures in patients with severe intractable epilepsy (Dravet Syndrome or Lennox Gastaut Syndrome), and to measure blood levels of CBD to help determine CBD concentration-response characteristics.

First Posted: 2016-09-22

Condition(s): Dravet Syndrome, Lennox Gastaut Syndrome

Intervention(s):

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation:

Sponsor: Gillette Children's Specialty Healthcare

Principal Investigator:

Completion Date (primary or actual): 2017-12-31

CT.gov Identifier: NCT02910297

Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in the Treatment of Rett Syndrome (RTT)

This 18-week open-label study examines the effectiveness of Full-Spectrum Medicinal Cannabis Plant Extract containing 0.08% THC (NTI164) in treating Rett syndrome (RTT) in children and young people. The study aims to determine the impact of NTI164 on RTT symptoms over a 16-week treatment period. Participants will start with a daily dose of 5 mg/kg of NTI164, which will be gradually increased over four weeks until they reach either the maximum tolerated dose or 20 mg/kg per day. They will then maintain this dose for eight weeks. Following this treatment phase, the dosage will be reduced by 5 mg/kg each week for four weeks until treatment concludes. The effectiveness of the treatment will be assessed using tailored questionnaires that measure changes in the patients\' conditions. Additionally, full blood examinations will be conducted at multiple points throughout the study to monitor the effects of the treatment.

First Posted: 2024-10-01

Condition(s): Rett Syndrome

Intervention(s): NTI164

Status: COMPLETED

Enrollment (expected or actual): 14

Allocation: NA

Sponsor: Fenix Innovation Group

Principal Investigator:

Completion Date (primary or actual): 2025-12-01

CT.gov Identifier: NCT06621043

Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam

The purpose of this study is to evaluate the abuse potential of CBD to determine whether it should remain as a Schedule I drug under the Controlled Substances Act, or be recommended for decontrol.

First Posted: 2018-01-12

Condition(s): Cannabis Use Disorder

Intervention(s): THC, Alprazolam, Placebo oral capsule, CBD

Status: COMPLETED

Enrollment (expected or actual): 42

Allocation: RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2018-05-30

CT.gov Identifier: NCT03398083

Effects of THC and CBD on Human Episodic Memory Function

THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC can induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has anxiolytic and possibly antipsychotic properties, while not impairing memory and other cognitive functions. Instead, CBD has been shown to have significant neuroprotective effects. In humans, CBD values correlated positively with gray matter concentration in bilateral hippocampus. Recent data from experimental animals and in vitro studies suggest that these distinct effects might be caused by opposing effects on brain cannabinoid receptors. Neuroimaging studies have consistently identified brain activity recorded at prefrontal and medial temporal regions as relevant for episodic memory. Additionally, the abundance of cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the evidence relating cannabinoids to these conditions is relatively recent and has been obtained from either biochemical or pharmacological studies. It might be hypothesized that CBDs could be useful to delay or even arrest the progression of functional and structural neuronal degeneration. The investigators will use an episodic memory paradigm to test the effects of THC, CBD and placebo on memory encoding and retention and the underlying neuronal networks on healthy male subjects.

First Posted: 2014-11-14

Condition(s): Healthy Volunteers

Intervention(s): Tetrahydrocannabinol, Cannabidiol, placebo

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Central Institute of Mental Health, Mannheim

Principal Investigator:

Completion Date (primary or actual): 2014-12

CT.gov Identifier: NCT02291562

Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with advanced hematologic malignancies. This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase 2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM) In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM). All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response. As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone to further evaluate this triple combination.

First Posted: 2014-02-26

Condition(s): Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma, Waldenstrom's Macroglobulinemia (WM), Other B-cell NHL Subtypes, Including WM, T-cell NHL

Intervention(s): CB-839, CB-839 and low dose dexamethasone, CB-839, pomalidomide, and low dose dexamethasone

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: NON_RANDOMIZED

Sponsor: Calithera Biosciences, Inc

Principal Investigator:

Completion Date (primary or actual): 2016-04

CT.gov Identifier: NCT02071888

Effect of L-dopa In Subacute Back Pain Population

This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).

First Posted: 2013-09-26

Condition(s): Sub-acute Back Pain

Intervention(s): Naproxen, Carbidopa/Levodopa, Placebo

Status: COMPLETED

Enrollment (expected or actual): 72

Allocation: RANDOMIZED

Sponsor: Northwestern University

Principal Investigator: Apkar Apkarian, Professor

Completion Date (primary or actual): 2017-09-25

CT.gov Identifier: NCT01951105

Age-Related Effects of THC

Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. A second major concern is the need to develop sensitive measures that can detect THC intoxication after recent use and enable robust comparisons of intoxication to determine sources of risk. One potential source of risk is age, specifically during the period of adolescence.

First Posted: 2020-03-04

Condition(s): Tolerance, Adolescent Behavior, THC

Intervention(s): Dextrose, Dronabinol, Dronabinol

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: University of Chicago

Principal Investigator:

Completion Date (primary or actual): 2021-05-01

CT.gov Identifier: NCT04294966

Abuse Potential of Sativex

This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use.

First Posted: 2011-03-25

Condition(s): Evaluation of Abuse Potential of Sativex

Intervention(s): Sativex, Sativex, Sativex, Placebo, Marinol, Marinol

Status: COMPLETED

Enrollment (expected or actual): 58

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2008-06

CT.gov Identifier: NCT01323569

A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.

First Posted: 2020-02-07

Condition(s): Healthy

Intervention(s): A1, A2, A3, A4, A5, B1, B2, B3, B4

Status: COMPLETED

Enrollment (expected or actual): 76

Allocation: RANDOMIZED

Sponsor: Breath of Life International Pharma Ltd

Principal Investigator:

Completion Date (primary or actual): 2022-10-24

CT.gov Identifier: NCT04261166

Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations

Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.

First Posted: 2021-04-23

Condition(s): Marijuana Impairment, Alcohol Impairment

Intervention(s): Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass, Placebo, 0.05 BAC Alcohol, 0.08 BAC Alcohol

Status: COMPLETED

Enrollment (expected or actual): 41

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Godfrey Pearlson, Principal Investigator

Completion Date (primary or actual): 2023-08-23

CT.gov Identifier: NCT04856566

Evaluation of the Effectiveness of Cannabidiol in Treating Severe Behavioural Problems in Children and Adolescents With Intellectual Disability

This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 weeks in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.

First Posted: 2021-03-30

Condition(s): Intellectual Disability, Child Behavior Problem

Intervention(s): Cannabidiol Oil, Placebo

Status: COMPLETED

Enrollment (expected or actual): 132

Allocation: RANDOMIZED

Sponsor: Murdoch Childrens Research Institute

Principal Investigator:

Completion Date (primary or actual): 2025-08-19

CT.gov Identifier: NCT04821856

Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.

First Posted: 2005-08-18

Condition(s): Depression, Marijuana Abuse

Intervention(s): Venlafaxine, Placebo

Status: COMPLETED

Enrollment (expected or actual): 123

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Frances R Levin, Director of Substance Use Disorder

Completion Date (primary or actual): 2010-12

CT.gov Identifier: NCT00131456

MIVetsCan: Can-Coach Trial (Phase 2)

The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

First Posted: 2024-02-28

Condition(s): Chronic Pain

Intervention(s): Educational Session

Status: RECRUITING

Enrollment (expected or actual): 468

Allocation: RANDOMIZED

Sponsor: University of Michigan

Principal Investigator: Kevin Boehnke, Assistant Professor, Anesthesiology

Completion Date (primary or actual): 2028-07-31

CT.gov Identifier: NCT06283862

Determining the Effect of Six Weeks of Cannabis Abstinence on Fronto- Striatal fMRI Markers in Adolescents With Cannabis Use Disorder (ABSCAN)

The goal of this study is to understand the changes in neural correlates of reward in adolescents with and without Cannabis Use Disorder (CUD). The study will collect functional magnetic resonance imaging (fMRI) data at 3 different timepoints with the primary goals of understanding striatal reward-based activation during a Monetary Incentive Delay Task and fronto-striatal fMRI resting-state functional connectivity. The study will also explore self-reported impulsivity. The long-term goal is to advance scientific understanding of neural changes associated with cannabis abstinence and inter-individual variability that cannot be otherwise measured in preexisting observational cohorts such as the Adolescent Brain Cognitive Development Study. This parallel intervention study will collect fMRI data in adolescents ages 15-18 years old with and without CUD at three different timepoints over the course of their intervention. Utilizing a validated paradigm, adolescents with CUD will be randomized to 6-weeks of either incentivized, biochemically verified abstinence via contingency management or monitoring with no required abstinence. Age- and sex-matched adolescents with no lifetime history of cannabis use will also complete the protocol. Participants will complete 9 study visits (3 with fMRI scans) involving urinalysis to confirm cannabis self-report and measures of impulsivity. Participants may additionally and optionally (1) complete daily remote self-report assessments of cannabis use, impulsivity, and mood throughout the 6-week treatment period, and (2) continue participation for an additional 6-week monitoring period after the treatment period, during which they complete daily remote self-report assessments of cannabis use, impulsivity, and mood.

First Posted: 2023-11-09

Condition(s): Cannabis Use Disorder

Intervention(s): CB-Abst, CB-Mon

Status: RECRUITING

Enrollment (expected or actual): 64

Allocation: RANDOMIZED

Sponsor: University of Minnesota

Principal Investigator:

Completion Date (primary or actual): 2028-04-15

CT.gov Identifier: NCT06124846

Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis

First Posted: 2022-08-23

Condition(s): Glioma

Intervention(s): PET/CT with 18F-DOPA

Status: RECRUITING

Enrollment (expected or actual): 88

Allocation: NA

Sponsor: Central Hospital, Nancy, France

Principal Investigator: Antoine VERGER, MD, PhD

Completion Date (primary or actual): 2026-10-30

CT.gov Identifier: NCT05512403

Clinical and Procedural Outcomes of Ostial Left Anterior Descending Artery Intervention With or Without Crossover to Left-main

Prospective interventional study evaluating clinical and procedural outcomes of patients with ostial left anterior descending artery lesion PCI alone or crossover with left main artery

First Posted: 2023-07-06

Condition(s): Coronary Artery Disease

Intervention(s): Percutaneous coronary intervention

Status: UNKNOWN

Enrollment (expected or actual): 72

Allocation: RANDOMIZED

Sponsor: Assiut University

Principal Investigator: MA Abdelreheem, Assistant lecturer

Completion Date (primary or actual): 2025-07

CT.gov Identifier: NCT05933473

Study of DSP-0390 in Patients With Recurrent High-Grade Glioma

This is a study of DSP-0390 in patients with recurrent high grade glioma.

First Posted: 2021-08-26

Condition(s): High Grade Glioma, Glioblastoma Multiforme

Intervention(s): DSP-0390

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 39

Allocation: NA

Sponsor: Sumitomo Pharma America, Inc.

Principal Investigator:

Completion Date (primary or actual): 2027-10-31

CT.gov Identifier: NCT05023551

Analgesic Efficacy of Smoked Cannabis

The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.

First Posted: 2005-10-19

Condition(s): Pain, Hyperalgesia

Intervention(s): Smoked Cannabis

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation: RANDOMIZED

Sponsor: Center for Medicinal Cannabis Research

Principal Investigator:

Completion Date (primary or actual): 2004-01

CT.gov Identifier: NCT00241579

Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia

This is a pilot study. The aim of the investigators' study is to evaluate the effectiveness of nigella sativa seed in the treatment of dyslipidemia. Dyslipidemia is a common risk factor for cardiovascular disease, the leading cause for morbidity and mortality among patients. Nigella sativa is an easily available and acceptable remedy to treat dyslipidemia and at a low cost. It is expected that by scientifically determining the effectiveness of this intervention it will lead to its widespread use. This will provide a low cost alternative to treat dyslipidemia.

First Posted: 2006-05-17

Condition(s): Hypercholesterolemia, Hypertension, Diabetes Mellitus, Metabolic Syndrome X

Intervention(s): Nigella sativa seed

Status: COMPLETED

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Aga Khan University

Principal Investigator:

Completion Date (primary or actual): 2007-03

CT.gov Identifier: NCT00327054

Behavioral Pharmacology of Cannabis in Older Adults

This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.

First Posted: 2023-09-26

Condition(s): Health Services for the Aged

Intervention(s): Cannabis (up to three doses)

Status: COMPLETED

Enrollment (expected or actual): 3

Allocation: NA

Sponsor: University of Arkansas

Principal Investigator:

Completion Date (primary or actual): 2025-12-31

CT.gov Identifier: NCT06055309

Niacin Flushing as Marker of Cannabis Effects on Arachidonic Acid Pathways in Schizophrenia

Increasing evidence suggests modulating effects of cannabinoids on time of onset, severity, and outcome of schizophrenia. Efforts to discover the underlying pathomechanism have led to the assumption of gene x environment interactions including premorbid genetical vulnerability and worsening effects of continuing cannabis use. For a main characteristic of psychoactive delta-9-tetrahydrocannabinol is its affinity to biological membranes, which are known to be disturbed in schizophrenia patients and genetic high-risk populations. Here we assess an hypothesised association between premorbid lipid disturbance and metabolic effects of external cannabinoids in schizophrenia. Intensity of niacin (methylnicotinate) skin flushing, indicating disturbed prostaglandin-mediated processes, is used as peripheral marker of lipid-arachidonic acid pathways and investigated in cannabis consuming and non-consuming schizophrenia patients and in healthy controls. Methylnicotinate is applied in three concentrations onto the forearm skin. Flush response is assessed in three minute intervals over 15 min using optical reflection spectroscopy.

First Posted: 2006-09-14

Condition(s): Schizophrenia, Cannabis Abuse

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 100

Allocation:

Sponsor: University of Jena

Principal Investigator:

Completion Date (primary or actual): 2005-06

CT.gov Identifier: NCT00376233

Neural Mechanisms of Cannabinoid-impaired Decision-Making in Emerging Adults

Emerging adults are a particularly vulnerable group for experiencing the immediate and potentially lifelong negative impacts of habitual cannabis use, and trends suggest that cannabis use disorder (CUD) will soon escalate in this population. The proposed research will combine clinical pharmacology, non-invasive brain stimulation, and neuroimaging techniques to establish the brain mechanisms of cannabinoid-impaired decision-making processes in emerging adults with CUD. Results from this project will inform CUD prevention/treatment efforts in this high-risk group and address a growing public health concern.

First Posted: 2019-05-10

Condition(s): Neurosciences, Substance-Related Disorders, Behavior Problem

Intervention(s): Placebo TMS Sham, Marinol 10Mg Capsule TMS Sham, Marinol 30Mg Capsule TMS Sham, Placebo TMS Real, Marinol 10Mg Capsule TMS Real, Marinol 30Mg Capsule TMS Real

Status: COMPLETED

Enrollment (expected or actual): 66

Allocation: RANDOMIZED

Sponsor: Michael J. Wesley, PhD

Principal Investigator: Michael J. Wesley, PhD, Assistant Professor

Completion Date (primary or actual): 2023-12-13

CT.gov Identifier: NCT03944954

An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

This study consisted of 2 parts: a double-blind (DB) phase and an open-label extension (OLE) phase. Only the OLE phase is described in this record. The OLE phase was a safety study. All participants received GWP42003-P initially titrated to 20 milligrams (mg)/kilograms (kg)/day; however, investigators subsequently decreased or increased the participant's dose to a maximum of 30 mg/kg/day (no minimum).

First Posted: 2015-10-01

Condition(s): Epilepsy

Intervention(s): GWP42003-P, Clobazam

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2017-06-07

CT.gov Identifier: NCT02564952

Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)

Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in every social level and is very prevalent in outpatient and inpatient settings. A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had beneficial effects abolishing or greatly reducing nightmares that persisted in spite of treatment with conventional PTSD medications. Furthermore, a big number of patients suffering from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep quality improvement. According to clinical and epidemiological data different derivates from the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce distress. The aim of the proposed study is to broaden the previous observations and to measure the extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD symptoms.

First Posted: 2009-08-26

Condition(s): Posttraumatic Stress Disorders

Intervention(s): Tetrahydrocannabinol, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 70

Allocation: RANDOMIZED

Sponsor: Hadassah Medical Organization

Principal Investigator:

Completion Date (primary or actual): 2013-04

CT.gov Identifier: NCT00965809

Stress and Marijuana Cue-elicited Craving and Reactivity

The purpose of this study is to explore the interaction between stress and marijuana cues, in hopes that it may lead to the development of new treatments for marijuana dependence.

First Posted: 2008-02-13

Condition(s): Cannabis Use Disorders

Intervention(s): Stress + cue exposure, No stress + cue exposure

Status: COMPLETED

Enrollment (expected or actual): 87

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: Aimee McRae-Clark, Associate Professor of Psychiatry

Completion Date (primary or actual): 2009-05

CT.gov Identifier: NCT00613405

A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain

The goal of this clinical trial is to learn about the use of cannabidiol (CBD) capsules as a treatment for musculoskeletal pain. CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. The main questions it aims to answer are: Is CBD more effective than placebo at relieving pain for upper extremity musculoskeletal pain ? Is CBD safe for participants with upper extremity musculoskeletal pain? Participants will: take 4 weeks of daily CBD capsules take 4 weeks of daily placebo capsules answer surveys about how they are feeling and functioning. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

First Posted: 2024-11-19

Condition(s): Upper Extremity Muscle Pain, Upper Extremity Bone Pain, Upper Extremity Pain

Intervention(s): Cannabidiol (CBD), Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Brent DeGeorge

Principal Investigator: Brent DeGeorge, Associate Professor of Plastic Surgery

Completion Date (primary or actual): 2026-03

CT.gov Identifier: NCT06695195

The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol

This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol administered via inhalation and oral ingestion.

First Posted: 2017-05-23

Condition(s): Cannabidiol Pharmacokinetics

Intervention(s): Oral or vaporized cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2020-01-22

CT.gov Identifier: NCT03164512

Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis

The purpose of this study is to determine whether nabilone (Cesamet) when used as an adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over gabapentin alone for the management of neuropathic pain in MS.

First Posted: 2007-05-30

Condition(s): Neuropathic Pain, Multiple Sclerosis

Intervention(s): nabilone, placebo

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: University of Manitoba

Principal Investigator:

Completion Date (primary or actual): 2012-07

CT.gov Identifier: NCT00480181

Haloperidol for the Treatment of Nausea and Vomiting in the ED

Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.

First Posted: 2021-02-21

Condition(s): Vomiting, Nausea, Abdominal Pain, Cannabis Use

Intervention(s): Haloperidol, Ondansetron

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Western Michigan University School of Medicine

Principal Investigator: Jessica J McCoy, MD FACEP, Clinical Associate Professor

Completion Date (primary or actual): 2023-05-22

CT.gov Identifier: NCT04764344

High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy. The names of the groups in this research study are: * High-Intensity Exercise (EX) * High-fiber Diet (DT) * Combined High-Intensity Exercise and High-Fiber Diet (COMB) * Attention Control (AC)

First Posted: 2024-03-07

Condition(s): Melanoma (Skin), Skin Cancer, Advanced Melanoma

Intervention(s): Exercise Program, Diet Program

Status: RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Fred Hutchinson Cancer Center

Principal Investigator:

Completion Date (primary or actual): 2027-07-31

CT.gov Identifier: NCT06298734

Dose-finding Pharmacokinetic Study in Healthy Males

This is a phase I PK study in healthy males.

First Posted: 2017-02-16

Condition(s): Healthy Volunteers

Intervention(s): Levodopa, Carbidopa, ODM-104

Status: COMPLETED

Enrollment (expected or actual): 56

Allocation: RANDOMIZED

Sponsor: Orion Corporation, Orion Pharma

Principal Investigator:

Completion Date (primary or actual): 2017-06-09

CT.gov Identifier: NCT03055936

Human Rhinovirus Infection and Airway Remodeling Mediators

In this study, the following subjects will be exposed to human rhinovirus (HRV): * those with classification of mild-moderate asthma * healthy control subjects. The investigators will study the kinetics of HRV-induced inflammatory and remodeling responses in a well characterized group of asthmatic subjects and compare these outcomes to those in a healthy, non-asthmatic control group.

First Posted: 2013-05-07

Condition(s): Asthma

Intervention(s): GMP-grade HRV-39, Bronchoalveolar Lavage, Methacholine Inhalation Challenge, Nasal Lavage, Nasal Scrapings, Bronchial Brushings, Lung Mucosal Biopsy, Allergen Skin Prick Testing, Venipuncture, Bronchoscopy, Spirometry

Status: TERMINATED

Enrollment (expected or actual): 2

Allocation: NON_RANDOMIZED

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Principal Investigator:

Completion Date (primary or actual): 2015-07

CT.gov Identifier: NCT01847768

Cannabis Impairment Detection Application (CIDA)

Subjects will participate in a 4-visit study protocol in which they will be asked to complete a set of computerized tasks and a 45-minute simulated drive in a driving simulator. Subjects will be administered marijuana of varying pre-determined concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) during 3 of the visits and alcohol during one of the visits. Throughout the duration of each visit, brain activity will be measured noninvasively using an electroencephalogram (EEG) headset. The purpose of this study is to: 1. Further understand the effects of acute cannabis intoxication on driving performance in a driving simulator 2. Develop and refine brain-based biomarkers of impairment due to acute cannabis intoxication

First Posted: 2020-01-18

Condition(s): Driving Under the Influence, Marijuana Intoxication, Alcohol Intoxication

Intervention(s): Cannabis (THC) (Inhaled) Placebo, Cannabis (High% THC) (Inhaled), Cannabis (Very High% THC) (Inhaled), Alcohol (oral)

Status: COMPLETED

Enrollment (expected or actual): 124

Allocation: RANDOMIZED

Sponsor: Advanced Brain Monitoring, Inc.

Principal Investigator:

Completion Date (primary or actual): 2021-05-27

CT.gov Identifier: NCT04230460

Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).

This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. Several drugs including: steroids, intravenous Gama globulin, Clobazam, other benzodiazepines, Valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. Cannabidiol (CBD) would provide a novel mechanism of action to assess for its efficacy in this population. This will be a double-blind placebo-controlled crossover clinical trial.

First Posted: 2021-01-25

Condition(s): Electrical Status Epilepticus of Slow-Wave Sleep

Intervention(s): Epidiolex 100 mg/mL Oral Solution, Placebo

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: RANDOMIZED

Sponsor: Northwell Health

Principal Investigator: Sanjeev Vithal Kothare, Director, Service Line Chief of Child Neurology

Completion Date (primary or actual): 2024-01-17

CT.gov Identifier: NCT04721691

Addiction in Adolescence - Pathomechanisms and Treatment Evaluation

This study aims to investigate the sociodemographic background as well as psychiatric comorbidities of adolescent substance users with substance use disorders. The study simultaneously evaluates biomarkers of stress and addiction, including long-term cortisol levels from hair samples and gene methylation in blood samples associated with substance use. Our study also adapts, rolls out, and evaluates an evaluated multimodal treatment manual wich was originally intended for stimulant drug users (MATRIX). We adopt this manual to the needs and specifics of adolescents (MATRIX-A, A=adolescents) with substance use disorders of any substance, including cannabis, methamphetamine, and alcohol. Adolescents will receive group therapy sessions, individual therapy sessions, and medication if needed, while parents or professional caretaker will receive group sessions. Therapy outcomes will be examined in addition to parental distress and parenting skills.

First Posted: 2018-02-26

Condition(s): Substance Use Disorders, Adolescent Behavior

Intervention(s): adapted treatment according to the MATRIX-A therapy

Status: UNKNOWN

Enrollment (expected or actual): 450

Allocation: NON_RANDOMIZED

Sponsor: Technische Universität Dresden

Principal Investigator:

Completion Date (primary or actual): 2021-12-31

CT.gov Identifier: NCT03444974

Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy

Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment. Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.

First Posted: 2012-03-02

Condition(s): Deep Venous Thrombosis, Pulmonary Embolism

Intervention(s): LMWH

Status: COMPLETED

Enrollment (expected or actual): 1500

Allocation: RANDOMIZED

Sponsor: Suzanne C. Cannegieter, MD PhD

Principal Investigator: Suzanne C. Cannegieter, MD PhD, Study director

Completion Date (primary or actual): 2016-09

CT.gov Identifier: NCT01542723

Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions

Cannabidiol (CBD) is available as a prescription drug product for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. At labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation and drug-induced liver injury has been observed. However, only limited evaluations of the risk of liver enzyme elevation of daily, lower dose CBD use are available. The potential for liver enzyme elevations with lower CBD doses with unapproved consumer products highlights a need for further research. In addition, CBD has the capacity to inhibit cytochrome P450 enzymes and uridine 5'-diphospho-glucuronosyltransferases, leading to potential drug-drug interactions with multiple common medications. The clinical significance of many of these interactions is also unclear. Furthermore, nonclinical studies have suggested the potential for CBD to cause reproductive and endocrine effects. As such, additional high-quality clinical pharmacology studies are needed to further characterize CBD's safety profile. The objective of this study is to characterize the effects of daily CBD use at a dose within the range of what consumers are taking as unapproved CBD products on liver enzyme elevations, drug interactions, and endocrine measures.

First Posted: 2024-01-05

Condition(s): Cannabidiol, Drug Induced Liver Injury, Drug Interaction

Intervention(s): Cannabidiol, Placebo, Citalopram, Morphine

Status: COMPLETED

Enrollment (expected or actual): 241

Allocation: RANDOMIZED

Sponsor: Food and Drug Administration (FDA)

Principal Investigator:

Completion Date (primary or actual): 2024-09-06

CT.gov Identifier: NCT06192589

Pilot Study Repetitive Transcranial Magnetic Stimulation (rTMS) in Cannabis Craving

Background: * Cannabis, also known as marijuana, is a commonly abused drug. There is no approved medication to treat cannabis addiction. The desire to use cannabis often increases when seeing others use it or seeing pictures of it. Researchers are interested in determining which parts of the brain are active when looking at pictures associated with cannabis. * Repetitive transcranial magnetic stimulation (rTMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether rTMS can decrease activity in the parts of the brain that respond to cannabis, and thereby lessen cravings for cannabis. Objectives: \- To determine whether transcranial magnetic stimulation can lower craving for cannabis when people who use cannabis are shown images that increase craving. Eligibility: \- Individuals 18 years of age and older who are physically healthy and currently use cannabis (at least 3 times weekly for the past 2 years). Design: * The study will involve eight visits over 3 weeks, with each visit lasting 1 to 2 hours. * Participants will have an initial assessment about cannabis use and provide blood and urine samples before beginning the study. * Participants will have three magnetic resonance imaging (MRI) brain scans. The first MRI scan will look at the structure of the brain at rest. During the other two scans, participants will look at images related to and not related to cannabis use. * The rTMS sessions (with either actual TMS or inactive \[sham\] TMS) will be held daily for 5 consecutive days. During these testing visits, researchers will ask questions related to drug use and craving, and collect urine and breath samples for further study. * Participants will have two follow-up visits, 1 week and 2 weeks after the rTMS sessions, to evaluate memory and mood, and one final MRI brain scan at the end of the study.

First Posted: 2009-12-14

Condition(s): Cannabis Use

Intervention(s): Repetitive Transcranial Magnetic Stimulation

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2012-02-27

CT.gov Identifier: NCT01031290

Cannabis Extract in Refractory Epilepsy Study

The purpose of this study is to examine whether a low dose of CBD+THC will decrease the frequency of convulsive seizures in adults with drug-resistant epilepsy, when used in addition to standard anti-epileptic drugs (AEDs). This study will also study the genes associated with epilepsy and whether different epileptic syndromes respond to treatment with CBD+THC.

First Posted: 2019-01-18

Condition(s): Drug Resistant Epilepsy

Intervention(s): Medical Cannabis, Placebo

Status: TERMINATED

Enrollment (expected or actual): 17

Allocation: RANDOMIZED

Sponsor: The Epilepsy Research Program of the Ontario Brain Institute

Principal Investigator:

Completion Date (primary or actual): 2020-03-15

CT.gov Identifier: NCT03808935

Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women

A total of 120 subjects in one center will be enrolled and will be divided into two treatment groups of 60 subjects each with 1:1 allocation ratio. Permuted block randomization will be used. Active treatment inlcude Nisatol® (developed by PharmExtracta) containing Nigella sativa seeds oil and Vitamin E, 1 capsule soft gel after breakfast and 1 capsule soft gel after dinner for 6 months; Control Intervention is Placebo.

First Posted: 2025-03-28

Condition(s): Perimenopausal Disorder, Impaired Glucose Tolerance, Impaired Fasting Glycemia

Intervention(s): Nisatol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Principal Investigator: Giuseppe Derosa, Principal Investigator

Completion Date (primary or actual): 2025-02-11

CT.gov Identifier: NCT06901076

Enhancing Medication-based Analgesia in Humans- STUDY 2

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.

First Posted: 2019-07-30

Condition(s): Pain, Cannabis, Opioid Use

Intervention(s): Within-subject test of blinded study medications

Status: COMPLETED

Enrollment (expected or actual): 31

Allocation: NA

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2022-11-01

CT.gov Identifier: NCT04036968

Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes

The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.

First Posted: 2012-06-12

Condition(s): Idiopathic Parkinson's Disease

Intervention(s): CVT-301, Placebo, Sinemet (carbidopa/levodopa), CVT-301

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: RANDOMIZED

Sponsor: Acorda Therapeutics

Principal Investigator:

Completion Date (primary or actual): 2012-12

CT.gov Identifier: NCT01617135

Behavioral Effects of Pregabalin and Cannabis

Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.

First Posted: 2012-01-18

Condition(s): Cannabis-use Disorders

Intervention(s): Pregabalin, Placebo

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Joshua A. Lile, Ph.D.

Principal Investigator: Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science

Completion Date (primary or actual): 2020-03-15

CT.gov Identifier: NCT01511640

Nicotine and Cannabis Vape Labeling Experiment - Spring 2025

This study assesses how the ways in which nicotine and cannabis vaping devices are labeled impact use susceptibility, anticipated effects, and health harm.

First Posted: 2025-04-09

Condition(s): Vaping, Adolescent, Electronic Cigarette Use, Nicotine, Cannabis

Intervention(s): Vaping Device Labeling

Status: COMPLETED

Enrollment (expected or actual): 3048

Allocation: RANDOMIZED

Sponsor: University of Southern California

Principal Investigator: Adam Leventhal, University Professor of Population & Public Health Sciences and Psychology

Completion Date (primary or actual): 2025-06-01

CT.gov Identifier: NCT06919276

Emotional Regulation, Impulsivity in Cannabis Its Relation to MRI Brain Structure

cannabis addiction is a major health hazard that has its effect on personality and behavior including the impulsivity and emotional regulation. It also has its effect on both the structure and function of different brain regions involved in brain reward system. the aim of the study is to study the emotional regulation and impulsivity among people with cannabis addiction studying the change in the volume of brain reward system structures' volume in relation to cannabis addiction and the change in the mentioned behavioral traits.

First Posted: 2018-03-30

Condition(s): Addiction

Intervention(s): MRI brain

Status: COMPLETED

Enrollment (expected or actual): 66

Allocation:

Sponsor: Assiut University

Principal Investigator: Sayed Mostafa, Lecturer of psychiatry

Completion Date (primary or actual): 2021-12-20

CT.gov Identifier: NCT03483220

Dyskinesia in Parkinson's Disease (Study P04501)

The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added. Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.

First Posted: 2006-12-04

Condition(s): Parkinson Disease, Movement Disorders, Central Nervous System Diseases, Neurodegenerative Diseases, Brain Diseases

Intervention(s): Preladenant, Preladenant, Preladenant, Preladenant, Placebo, L-dopa, Other Parkinson's Disease treatments

Status: COMPLETED

Enrollment (expected or actual): 253

Allocation: RANDOMIZED

Sponsor: Merck Sharp & Dohme LLC

Principal Investigator:

Completion Date (primary or actual): 2008-11-03

CT.gov Identifier: NCT00406029

Cannabis Tolerance Break Resource Study: T-Break Guide

The purpose of this pilot study is to conduct research into the value of using the T-Break Guide for assisting people taking a tolerance break from cannabis. The hope is that this initial research will yield some insights and benchmarks into the Guide's efficacy, and provide a foundation for a later randomized control study. The following are some key research questions: 1. How did participants use the Guide? (Eg: daily; read once; 'a la carte') 2. How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)? 3. Did using the Guide yield any benefits beyond tolerance break fidelity? (Eg: insight into patterns of use)

First Posted: 2022-05-19

Condition(s): Cannabis Use, Tolerance, Cannabis Withdrawal

Intervention(s): T-Break Guide

Status: COMPLETED

Enrollment (expected or actual): 151

Allocation:

Sponsor: University of Vermont

Principal Investigator: Tom Fontana, Alcohol, Cannabis & Other Drugs Initiatives Manager

Completion Date (primary or actual): 2021-08-01

CT.gov Identifier: NCT05382273

Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)

The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.

First Posted: 2021-11-01

Condition(s): Obstructive Sleep Apnea

Intervention(s): Dosing 1: Atomoxetine, AD313

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation: NON_RANDOMIZED

Sponsor: Apnimed

Principal Investigator:

Completion Date (primary or actual): 2022-04-18

CT.gov Identifier: NCT05101122

Clinical Trial of Levodopa/Carbidopa ( Sinemet) Therapy in Angel Man Syndrome

The purpose of this study is to evaluate the safety and effectiveness (how well a drug works) of Carbidopa/levodopa (Sinemet) in individuals with Angelman syndrome. Sinemet is a medication that helps to raise dopamine levels (a chemical that signals nerve cells) in the brain and central nervous system. There is evidence that dopamine concentrations may be abnormal in patients with Angelman syndrome. This study is investigating whether Sinemet helps motor control, intellectual function and the achievement of developmental milestones in people with Angelman syndrome

First Posted: 2017-08-01

Condition(s): Angelman Syndrome

Intervention(s): Levodopa

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: Bennett Lavenstein

Principal Investigator: Bennett Lavenstein, MD

Completion Date (primary or actual): 2019-02-01

CT.gov Identifier: NCT03235037

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders, characterized by the accumulation of alpha-synuclein in neurons and/or glia. The anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of progressive neuronal death (e.g. caudal to rostral brainstem) give rise to distinct neurological phenotypes, including Parkinson's disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB). Common to these disorders are the involvement of the central and peripheral autonomic nervous system, where Pure Autonomic Failure (PAF) is thought (a) to be restricted to the peripheral autonomic system, and (b) a clinical risk factor for the development of a central synucleinopathy, and (c) an ideal model to assess biomarkers that predict phenoconversion to PD, MSA, or DLB. Such biomarkers would aid in clinical trial inclusion criteria to ensure assessments of disease- modifying strategies to, delay, or halt, the neurodegenerative process. One of these biomarkers may be related to the neurotransmitter dopamine (DA) and related changes in the substantia nigra (SN) and brainstem. \[18F\]F-DOPA is a radiolabeled substrate for aromatic amino acid decarboxylase (AAADC), an enzyme involved in the production of dopamine. Use of this radiolabeled substrate in positron emission tomography (PET) may provide insight to changes in monoamine production and how they relate to specific phenoconversions in PAF patients. Overall, this study aims to identify changes in dopamine production in key regions including the SN, locus coeruleus, and brainstem to distinguish between patients with PD, MSA, and DLB, which may provide vital information to predict conversion from peripheral to central nervous system disease.

First Posted: 2020-01-29

Condition(s): Autonomic Failure, Pure Autonomic Failure, Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies

Intervention(s): [18F]FDOPA, Carbidopa 200mg oral dose, Entacapone 400mg oral dose

Status: RECRUITING

Enrollment (expected or actual): 40

Allocation: NA

Sponsor: Daniel Claassen

Principal Investigator: Daniel Claassen, Professor of Neurology

Completion Date (primary or actual): 2027-02-01

CT.gov Identifier: NCT04246437

The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)

This study seeks to exploit bladder cannabidiol receptors as a therapeutic drug target by conducting a double-masked, placebo-controlled randomized trial evaluating the effects of vaginal hemp cannabidiol (CBD) suppositories on lower urinary tract symptoms (LUTS), pain severity, and sexual function.

First Posted: 2020-04-16

Condition(s): Interstitial Cystitis, Bladder Pain Syndrome

Intervention(s): Cannabidiol vaginal suppository, Placebo vaginal suppository

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: University of New Mexico

Principal Investigator: Gena Dunivan, M.D, Associate Professor

Completion Date (primary or actual): 2022-09

CT.gov Identifier: NCT04349930

Culturally Tailored Cannabis Use Disorder App

The present study aims to address disparities in cannabis use outcomes among African American/Black (hereby referred to as Black) adults with cannabis use disorder (CUD). The specific aims of this study are: (1) to develop a culturally adapted, mobile app for Black cannabis users (CT-MICART) using knowledge from the current research team, published literature, expert opinion, and feedback from the Community Research Advisory Board (CRAB), (2) to pilot test CT-MICART and (3) focus on analysis of data collected as part of Aim 2.

First Posted: 2022-10-04

Condition(s): Cannabis Use

Intervention(s): CT-MICART App, Control

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: NA

Sponsor: University of Houston

Principal Investigator: Lorra Garey, Principal Investigator

Completion Date (primary or actual): 2024-01-31

CT.gov Identifier: NCT05566730

Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis Withdrawal

The primary purpose is to assess the efficacy in human of N-acetylcysteine versus placebo during 4 weeks in cannabis withdrawal.

First Posted: 2011-09-23

Condition(s): Cannabis Dependence, Cannabis Abuse

Intervention(s): N-acetylcystein

Status: TERMINATED

Enrollment (expected or actual): 6

Allocation: RANDOMIZED

Sponsor: Assistance Publique - Hôpitaux de Paris

Principal Investigator:

Completion Date (primary or actual): 2015-02

CT.gov Identifier: NCT01439828

Investigating Cannabis Use Parameters on Anesthesia and Inflammation in Lumbar Spinal Surgeries

Cannabis is the most commonly used illicit drug in the United States with reported rates of use increasing from approximately 50 million in 2020 to 61.8 million in 2023 among individuals aged 12 or older. This rise can be attributed to a combination of growing social acceptance and expanding legalization for recreational and medical use of cannabis. Consequently, this has led to increased commercially available cannabis products with heterogeneous concentrations of cannabinoids (i.e., THC:CBD ratios) and new methods of administration becoming more available (e.g., vaping and gummies). Taken together, this rapidly shifting landscape further contributes to the significant variability in individual use patterns (i.e., frequency, duration, and route of administration) resulting in diverse clinical responses, which poses significant challenges for anesthetic management. Recent systematic reviews and meta-analysis have quantitatively demonstrated that cannabis users require higher dosages during anesthesia induction, experience greater hemodynamic instability, and report higher opioid consumption and pain scores post-operatively. These findings have led to the prevailing notion that cannabis exposure adversely affect anesthetic management. Yet, key cannabis exposure parameters in individual use patterns (i.e., variations in THC:CBD ratios, route of administration, frequency, and duration of use) remain poorly characterized and could confound observed clinical effects in relation to their effects on pain modulation and anesthetic requirements. Current perioperative assessments do not account for these critical variables, creating a gap that limits the development of more accurate and personalized anesthetic protocols. Failure to account for individual cannabis exposure parameters may lead to inappropriate anesthetic dosing - where underdosing could result in intraoperative awareness, pain, or patient movement, while overdosing might cause cardiovascular depression, respiratory failure, or prolonged recovery from anesthesia. Concomitantly, researchers have discovered that cannabis consumption modulates immune function such that early life exposure to cannabis produces a long-lasting and persistent inflammatory state characterized by reduced serum levels of IL-6, TNF-α, and IL-2. In contrast, recent research demonstrates that cannabinoid exposure improves skin healing in patients with cutaneous disorders. However, the effects of altered inflammatory responses, and the diverse actions of various cannabinoids on postoperative wound healing remain largely unexplored. Our long-term goal is to elucidate the mechanistic impact of chronic cannabis use parameters on anesthetic and analgesic requirements, thereby enabling the development of personalized, evidence-based perioperative management strategies. The investigators hypothesize that chronic cannabis exposure leads to impaired endogenous pain and immune modulation, resulting in increased intraoperative anesthetic dosing, heightened hemodynamic variability, and elevated postoperative pain and inflammation.

First Posted: 2026-01-21

Condition(s): Cannabis Use

Intervention(s):

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 210

Allocation:

Sponsor: University of Missouri-Columbia

Principal Investigator: Pias Malaker, Principal Investigator

Completion Date (primary or actual): 2027-05-30

CT.gov Identifier: NCT07354412

Carbidopa for the Treatment of Excessive Blood Pressure Variability

The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension and normalize or reduce the exaggerated blood pressure variability in patients with familial dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or Riley-Day syndrome). Funding Source- FDA OOPD.

First Posted: 2015-09-17

Condition(s): Dysautonomia, Familial, Baroreflex Failure Syndrome

Intervention(s): Carbidopa Low-Dose, Placebo, Carbidopa High-Dose

Status: COMPLETED

Enrollment (expected or actual): 22

Allocation: RANDOMIZED

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): 2019-05-10

CT.gov Identifier: NCT02553265

Rewards for Cannabis Abstinence-study

The goal of this clinical trial is to investigate the (cost-)effectiveness of contingency management (CM) compared with Cognitive Behavioural Therapy (CBT) for the treatment of cannabis use disorder (CUD) in youth (16-22 years). The main questions it aims to answer are: * What is the efficacy of 12 weeks outpatient CM versus CBT in youths with a CUD, in terms of cannabis abstinence during the intervention period? * What is the long-term efficacy of CM versus CBT at 6- and 12-months follow-up (FU)? * What is the cost-effectiveness of CM versus CBT at 12-months FU from a societal perspective? Study hypotheses are: 1\. CM will result in more cannabis-abstinent days than CBT during the intervention; 2. CM is more effective and cost-effective than CBT at 12 months follow-up. Eligible patients (n=154) will be randomly assigned to either 12 weeks of outpatient CM or CBT. Assessments are conducted by trained research-assistants at baseline, after 6, 12, 26 and 52 weeks, and twice-weekly during treatment and consist of questionnaires, a computer task and collection of urine samples. Primary endpoint is the number of biochemically verified cannabis abstinent days in the 12-week treatment period. Key secondary endpoint: Treatment response: 50% or more reduction in cannabis use days in the past 4 weeks, compared with baseline. The primary outcome will be modelled in the intention-to-treat population in a (negative binomial) regression analysis with treatment group as independent variable and stratification variables as covariates. Cost-effectiveness and cost-utility analysis (CEA; CUA) will be performed from a societal perspective. CEA: Treatment response is the central clinical endpoint for calculations of incremental costs per responder. CUA: Incremental costs per QALY (based on EuroQoL).

First Posted: 2023-05-01

Condition(s): Cannabis Use Disorder

Intervention(s): Abstinence-focused Contingency Management (CM) - stand alone, Standard Outpatient Cognitive Behavioural Therapy (CBT)

Status: RECRUITING

Enrollment (expected or actual): 154

Allocation: RANDOMIZED

Sponsor: Parnassia Addiction Research Centre

Principal Investigator:

Completion Date (primary or actual): 2027-09

CT.gov Identifier: NCT05836207

Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients

To improve self-care and therapy adherence by fibromyalgia (FM) patients through a nursing educational intervention. Historic diagnoses of subjects included terms such as "insane", "imaginary ill", "whiny"; as well, their physical conditions were underestimated by their immediate families. All subjects have problematic employment histories which consistently identified their varied employments as physically too demanding. Over time, increased physician- and societal-awareness, resulted in all subjects being diagnosed with FM; consequently, all subjects reported a strong desire to become well-informed about FM and its treatment. Although medical cannabis (MC) was an available therapy, twenty subjects reported that cannabis had never been proposed despite years of ineffective therapies. In this tudy the effects of a educational intervention by expert nurses on fibromyalgia and MC use were investigated.

First Posted: 2022-02-18

Condition(s): Fibromyalgia

Intervention(s): Educational intervention

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: NA

Sponsor: University of Milano Bicocca

Principal Investigator: Antonio Biagio Torsello, Professor

Completion Date (primary or actual): 2021-03-01

CT.gov Identifier: NCT05247411

Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.

First Posted: 2012-03-12

Condition(s): Pancreatitis, Chronic, Abdominal Pain, Chronic Pain

Intervention(s): Tetrahydrocannabinol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 29

Allocation: RANDOMIZED

Sponsor: Radboud University Medical Center

Principal Investigator:

Completion Date (primary or actual): 2014-06

CT.gov Identifier: NCT01551511

Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

This research aims to determine the effects and safety of cannabidiol (CBD) (ATL5 softgel capsules) as an adjunctive therapy for patients who have Opioid Use Disorder and are taking buprenorphine + naloxone or methadone. Buprenorphine + naloxone and methadone is an approved treatment for Opioid Use Disorder, but relapse to opioid misuse is common among patients who receive this treatment. Finding an adjunctive treatment for these patients would be helpful. We will recruit participants from the Tarzana Treatment Center (TTC) in the San Fernando Valley. They will be receiving buprenorphine + naloxone or methadone as part of residential therapy. Potential participants who pass initial screening and wish to continue in the study will provide written, informed consent and will complete a 2-day evaluation, including blood and urine tests, questionnaires about their mood, medical, psychiatric and drug use history and physical exam. Up to 60 participants who meet all eligibility criteria will be invited to complete baseline assessments (blood and urine tests, questionnaires), and will be assigned randomly to receive CBD (600 mg/day) or placebo, corresponding to two groups of up to 30 participants each. After the baseline measurements, participants will take part in a 28-day treatment phase for 4 weeks. They will take the study medication under supervision (CBD 300 mg twice daily or placebo). Questionnaires on opioid craving, withdrawal, and mood symptoms will be administered daily during the treatment period, excluding weekends. After the 28-day intervention, participants will complete the questionnaires and undergo urine drug tests in 4 weekly follow-up visits. The study will last \~10 weeks, comprising three periods: a screening period (2-weeks when participants are stabilized on buprenorphine + naloxone or methadone in residential treatment at the Tarzana Treatment Center), a treatment period (4 weeks when study CBD or placebo is administered at Tarzana Treatment Center), and a follow-up period (4 weeks after termination of the test intervention).

First Posted: 2018-12-26

Condition(s): Opioid-use Disorder

Intervention(s): Cannabidiol (CBD) 600 mg, Placebo

Status: COMPLETED

Enrollment (expected or actual): 35

Allocation: RANDOMIZED

Sponsor: University of California, Los Angeles

Principal Investigator: Edythe London, Distinguished Professor in Residence

Completion Date (primary or actual): 2024-03-12

CT.gov Identifier: NCT03787628

Enhancing Medication-based Analgesia in Humans

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).

First Posted: 2016-09-15

Condition(s): Pain, Cannabis, Opioid Use, Unspecified

Intervention(s): Within-subject test of blinded study medications

Status: COMPLETED

Enrollment (expected or actual): 29

Allocation: NA

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2020-03-23

CT.gov Identifier: NCT02901275

Cohort Study on Medical Students' Mental Health

The main objective of this study is to identify risk factors for depression among medical students by comparing them to students who completed their first year but did not enter the medical program (students not accepted into the second year of medical school). Major Depressive Disorder (MDD) will be assessed using a validated tool: the Composite International Diagnostic Interview Short-Form (CIDI-SF). This a prospective, longitudinal, cohort study. The plan is to inform each new cohort of students at the Orléans University Hospital medical school for 10 years. It is estimated that 5,000 to 10,000 students will be able to participate in the study. A link to access the study questionnaire will be sent to students by email via the registrar's office, with one email per week for four weeks. The email will contain a link to a web page where the questionnaire can be completed. The questionnaire will be available online on computers or smartphones for six weeks: from mid-October to the end of November. The questionnaire will be completed each year for the duration of the study or until the student completes their studies. Duration of the inclusion period: 10 years Duration of participation for each participant: maximum 12 years Total duration of the study: 22 years As the cohort progresses, longitudinal analyses may be conducted to study the evolution of various disorders over time, adjusting for known confounding factors. Following the initial analyses of this study, a new interventional study will be set up to identify students at risk and offer them appropriate care.

First Posted: 2025-12-26

Condition(s): Major Depressive Disorder, Generalized Anxiety Disorder, Suicidal Ideation, Alcoholism, Marijuana Abuse, Loneliness

Intervention(s): Questionnaire

Status: RECRUITING

Enrollment (expected or actual): 10000

Allocation:

Sponsor: Centre Hospitalier Régional d'Orléans

Principal Investigator:

Completion Date (primary or actual): 2047-10-31

CT.gov Identifier: NCT07305701

A Laboratory Model of Increasing Delta-9-tetrahydrocannabinol (THC) Potency on Cigarette Smoking

The objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. This study will be a within-subjects, placebo-controlled study in our clinical laboratory of the effect of active vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.

First Posted: 2016-11-10

Condition(s): Tobacco Use

Intervention(s): THC

Status: COMPLETED

Enrollment (expected or actual): 9

Allocation: RANDOMIZED

Sponsor: Battelle Memorial Institute

Principal Investigator:

Completion Date (primary or actual): 2019-09-30

CT.gov Identifier: NCT02961309

Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream

This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.

First Posted: 2024-03-27

Condition(s): Cannabis Dependence

Intervention(s): Biospecimen Collection, Cannabis sativa Extract, Nicotine, Placebo Administration, Questionnaire Administration

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Roswell Park Cancer Institute

Principal Investigator:

Completion Date (primary or actual): 2028-03-01

CT.gov Identifier: NCT06334016

Varenicline as a Treatment for Cannabis Use Disorder

Marijuana is the most commonly used illicit drug, and there is a high demand for effective treatments for cannabis use disorder, yet few specific pharmacological treatments have been developed. This study will evaluate the efficacy and safety of varenicline for reducing marijuana use in adults who use marijuana frequently. Participants will be randomized to receive either varenicline or placebo for 12 weeks, along with computerized cognitive behavioral therapy. Cannabis use, medication adherence, and safety outcomes will be assessed throughout treatment and at a follow-up visit.

First Posted: 2026-08-25

Condition(s): Cannabis Abuse

Intervention(s): Varenicline (Chantix), Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 224

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: Aimee McRae-Clark, Professor-Faculty

Completion Date (primary or actual): 2031-11-30

CT.gov Identifier: NCT07783555

Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients

The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.

First Posted: 2018-07-03

Condition(s): Parkinson Disease

Intervention(s): Accordion Pill Carbidopa/Levodopa, Sinemet CR 25Mg-100Mg Extended-Release Tablet

Status: UNKNOWN

Enrollment (expected or actual): 12

Allocation: NON_RANDOMIZED

Sponsor: Intec Pharma Ltd.

Principal Investigator:

Completion Date (primary or actual): 2019-01

CT.gov Identifier: NCT03576638

Impact of Cannabinoids on Menopause Symptoms

The purpose of the study is to examine the impact of the hemp-derived minor cannabinoids on symptoms of menopause/perimenopause.

First Posted: 2025-02-18

Condition(s): Perimenopause, Menopause

Intervention(s): Active Cannabinoid Product, Placebo

Status: COMPLETED

Enrollment (expected or actual): 104

Allocation: RANDOMIZED

Sponsor: Washington State University

Principal Investigator: Carrie Cuttler, Associate Professor

Completion Date (primary or actual): 2025-10-30

CT.gov Identifier: NCT06831916

Effects of Cannabidiol (CBD) on the Activation of Autophagy and Inflammation Genes, Functional Consequences in Virologically Controlled HIV-infected Patients

Autophagy and apoptosis are natural cellular mechanisms which consist for the first in a recycling and elimination process of potentially toxic cellular waste, and for the second in a process of cellular suicide when it becomes abnormal and "not" repairable, notably by autophagy. A deficit in autophagic function at the cellular level can lead to chronic inflammation and accelerated cellular senescence. Apoptosis is a beneficial phenomenon because it eliminates abnormal cells that could endanger the organism if it survives (e.g. karyotypic atypia). Uncontrolled, it can be deleterious if apoptosis is hypo or hyperactive.

First Posted: 2022-04-01

Condition(s): HIV Seropositivity

Intervention(s): CBD LGP 50, Placebo

Status: COMPLETED

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Centre Hospitalier Régional d'Orléans

Principal Investigator:

Completion Date (primary or actual): 2023-02-08

CT.gov Identifier: NCT05306249

Behavioral Pharmacology of THC and Alpha-pinene

This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized alpha-pinene and THC administered via inhalation.

First Posted: 2019-10-17

Condition(s): THC, Alpha-pinene

Intervention(s): Placebo, THC, Alpha-Pinene

Status: COMPLETED

Enrollment (expected or actual): 33

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2024-03-08

CT.gov Identifier: NCT04130633

Improvement of Quality of Life by Cannabinoids in Oncologic Patients

The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.

First Posted: 2023-10-24

Condition(s): Medical Oncology, Palliative Care, Quality of Life, Cannabinoids

Intervention(s): Cannabisextrakt Avextra 10/10 Lösung

Status: TERMINATED

Enrollment (expected or actual): 79

Allocation: RANDOMIZED

Sponsor: University Hospital Schleswig-Holstein

Principal Investigator:

Completion Date (primary or actual): 2026-02-05

CT.gov Identifier: NCT06097533

Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with cancer.

First Posted: 2006-09-27

Condition(s): Peripheral Neuropathy, Antineoplastic Combined Chemotherapy Protocols

Intervention(s): Cesamet™ (nabilone)

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: NON_RANDOMIZED

Sponsor: NEMA Research, Inc.

Principal Investigator:

Completion Date (primary or actual): 2007-10

CT.gov Identifier: NCT00380965

Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure

This study is designed to track brain functional changes in individuals with i) chronic back pain + opioid use (CBP+O) and individuals with ii) chronic back pain + opioid misuse disorder (CBP+mOUD) following a brief drug delay and re-exposure manipulation. Re-exposure could be placebo, the participant's own opioid dose, or a dopaminergic treatment (DA+NSAID). The participants will be also evaluated for changes in cognition, emotion, and motor abilities with opioid delay and re-exposure to placebo, opioid, or DA+NSAID.

First Posted: 2022-07-19

Condition(s): Opioid Use, Opioid Dependence, Opioid-use Disorder, Narcotic Use, Back Pain, Back Injuries, Chronic Pain, Chronic Low-back Pain, Pain, Chronic, Pain;Back Low;Chronic, Pain, Back

Intervention(s): Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg, Opioids

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Northwestern University

Principal Investigator: Apkar Apkarian, Principal Investigator

Completion Date (primary or actual): 2025-06-01

CT.gov Identifier: NCT05463367

Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions. The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.

First Posted: 2015-11-16

Condition(s): Healthy

Intervention(s): Treatment A, Treatment B, Treatment C

Status: COMPLETED

Enrollment (expected or actual): 54

Allocation: RANDOMIZED

Sponsor: INSYS Therapeutics Inc

Principal Investigator:

Completion Date (primary or actual): 2015-12

CT.gov Identifier: NCT02604992

Epidiolex in Obsessive Compulsive Disorder and Related Disorders

The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.

First Posted: 2021-07-27

Condition(s): Obsessive-Compulsive Disorder, Trichotillomania (Hair-Pulling Disorder), Tourette Syndrome, Hoarding Disorder

Intervention(s): Cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 4

Allocation: NA

Sponsor: University of Chicago

Principal Investigator:

Completion Date (primary or actual): 2025-11-01

CT.gov Identifier: NCT04978428

Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

Study based on the pharmacokinetic, pharmacodynamic, safety and stability evaluation of 3 standardized formulations of THC, to be used in healthy volunteers and post-chemotherapy patients as an adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.

First Posted: 2022-03-10

Condition(s): Nausea Post Chemotherapy, Vomiting, Cancer Pain, Cancer Related Pain, Neoplasms

Intervention(s): Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Status: UNKNOWN

Enrollment (expected or actual): 334

Allocation: RANDOMIZED

Sponsor: LaSanta S A S

Principal Investigator:

Completion Date (primary or actual): 2024-10-17

CT.gov Identifier: NCT05272865

A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.

First Posted: 2015-12-17

Condition(s): Asthma

Intervention(s): CVT-301 (levodopa inhalation powder), Carbidopa, Placebo

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: RANDOMIZED

Sponsor: Acorda Therapeutics

Principal Investigator:

Completion Date (primary or actual): 2016-05

CT.gov Identifier: NCT02633007

Vaporization as a Smokeless Cannabis Delivery System

A study to evaluate the use of a vaporization system as a smokeless delivery system for inhaled marijuana.

First Posted: 2005-10-19

Condition(s): Healthy Volunteers

Intervention(s): Cannabis

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: RANDOMIZED

Sponsor: Center for Medicinal Cannabis Research

Principal Investigator:

Completion Date (primary or actual): 2005-05

CT.gov Identifier: NCT00241592

A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis

Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Instead, most focus on ceasing cannabis use which is rarely appealing to cannabis users. Furthermore, face-to-face psychotherapy often remains inaccessible to people with psychosis mostly due to lack of trained clinicians. Alternatives such as e-interventions have the potential to increase access to treatment and decrease clinicians' workload. Among cannabis harm reduction approaches are the protective behavioural strategies. These strategies do not encourage nor discourage cannabis use. Instead, they recommend behaviours for safer cannabis use. For example, these strategies include: 1) avoid driving a car under the influence of cannabis, 2) avoid mixing cannabis with other drugs and 3) purchase cannabis only from a trusted source. In the present pan-Canadian study, we will test the first e-intervention called CHAMPS (Cannabis Harm-reducing App for Managing Practices Safely) for cannabis harm reduction adapted for young adult cannabis users who experienced a psychosis. CHAMPS is a smartphone application that includes 17 strategies for safer cannabis use, a personalized consumption goal and a consumption journal. The goals of this study are 1) to confirm whether CHAMPS is acceptable to participants and 2) to test whether it works, notably by positively impacting participants' health and cannabis consumption habits.

First Posted: 2021-07-20

Condition(s): Psychotic Disorder, Marijuana Use, Young Adult

Intervention(s): CHAMPS

Status: COMPLETED

Enrollment (expected or actual): 101

Allocation: RANDOMIZED

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

Completion Date (primary or actual): 2023-10-24

CT.gov Identifier: NCT04968275

Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or radiotracer, \[11C\]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available. Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.

First Posted: 2012-11-21

Condition(s): Schizophrenia, Cannabis Dependence, Prodromal for Psychotic Illness, Family History of Alcoholism, Healthy Control, Opioid-use Disorder, Post Traumatic Stress Disorder

Intervention(s): [11-C]OMAR

Status: RECRUITING

Enrollment (expected or actual): 100

Allocation:

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Associate Professor

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT01730781

Cannabis for Palliative Care in Cancer

Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.

First Posted: 2024-02-20

Condition(s): Sleep, Anxiety, Depression, Pain

Intervention(s): fsCBD Cannabidiol, Placebo, bsCBD Cannabidiol

Status: RECRUITING

Enrollment (expected or actual): 185

Allocation: RANDOMIZED

Sponsor: University of Colorado, Boulder

Principal Investigator: Angela Bryan, Professor

Completion Date (primary or actual): 2028-06-30

CT.gov Identifier: NCT06266611

A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes

The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months. The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes.

First Posted: 2023-07-21

Condition(s): PSP, CBD, Progressive Supranuclear Palsy, FTD, Corticobasal Degeneration, Frontotemporal Dementia, Frontotemporal Lobar Degeneration

Intervention(s): PAMSys, LEGSys

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 60

Allocation:

Sponsor: Massachusetts General Hospital

Principal Investigator: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology

Completion Date (primary or actual): 2027-12-30

CT.gov Identifier: NCT05956834

The Effects of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment

A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood

First Posted: 2021-08-26

Condition(s): Mild Cognitive Impairment

Intervention(s): Cannabidiol Oil, Homotaurine

Status: UNKNOWN

Enrollment (expected or actual): 90

Allocation: RANDOMIZED

Sponsor: Aristotle University Of Thessaloniki

Principal Investigator: Magda Tsolaki, Professor of Neurology, Medical School, Aristotle University of Thessaloniki

Completion Date (primary or actual): 2022-12-20

CT.gov Identifier: NCT05022186

Effects of Marijuana on Neuropathic Pain and Spasticity in Spinal Cord Injury Patients

The goal of this clinical trial is to compare effects of marijuana or cannabis on neuropathic pain and spasticity in spinal cord injury patients. The main question is: Does the cannabis product from KhonKaen University reduce neuropathic pain and spasticity in spinal cord injury patients? The research design is a crossover study. The participants will be randomly into 2 groups: group 1 and group 2. The participants received either cannabis or placebo for 2 weeks. After completing treatment, participants were swapped to the other group for 2 weeks, a wash-out period is 2 weeks. The outcome measurements are pain and spasticity.

First Posted: 2024-01-05

Condition(s): Spinal Cord Injury

Intervention(s): Cannabis, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Khon Kaen University

Principal Investigator: Nuttaset Manimmanakorn, Rehabilitation Medicine Department Faculty of Medicine

Completion Date (primary or actual): 2024-06-30

CT.gov Identifier: NCT06190470

Sequential Cadaveric Lung and Bone Marrow Transplant for Immune Deficiency Diseases

The purpose of this study is to determine whether bilateral orthotopic lung transplantation (BOLT) followed by cadaveric partially-matched hematopoietic stem cell transplantation (HSCT) is safe and effective for patients aged 5-45 years with primary immunodeficiency (PID) and end-stage lung disease.

First Posted: 2013-05-13

Condition(s): Severe Combined Immunodeficiency (SCID), Immunodeficiency With Predominant T-cell Defect, Unspecified, Severe Chronic Neutropenia, Chronic Granulomatous Disease (CGD), Hyper IgE Syndromes, Hyper IgM Deficiencies, Wiskott-Aldrich Syndrome, Mendelian Susceptibility to Mycobacterial Disease, Common Variable Immune Deficiency (CVID)

Intervention(s): CD3/CD19 negative allogeneic hematopoietic stem cells

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 16

Allocation: NA

Sponsor: Paul Szabolcs

Principal Investigator: Paul Szabolcs, Chief, Division of Blood and Marrow Transplant, Children's Hospital of Pittsburgh of UPMC

Completion Date (primary or actual): 2027-11

CT.gov Identifier: NCT01852370

Patients' Attitudes Toward and Experiences With Buprenorphine Treatment

This study will disseminate five surveys collecting individual's attitudes and experiences during buprenorphine treatment for Opioid Use Disorder during the COVID-19 pandemic.

First Posted: 2021-11-16

Condition(s): Opioid-use Disorder, Acceptability of Health Care, Opioid-Related Disorders

Intervention(s):

Status: SUSPENDED

Enrollment (expected or actual): 817

Allocation:

Sponsor: Cambridge Health Alliance

Principal Investigator:

Completion Date (primary or actual): 2027-03-20

CT.gov Identifier: NCT05121428

Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.

First Posted: 2021-08-25

Condition(s): Knee Arthritis

Intervention(s): Cannabidiol (CBD), Placebo

Status: RECRUITING

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): 2027-09

CT.gov Identifier: NCT05020028

Exercise Intervention as Treatment for People Using Cannabis (ExIT-C)

In Hong Kong, although the total number of drug abusers is trending down in recent years, the number of cannabis users continues to surge. The misuse of cannabis, if left unattended, predisposes various degrees of dependence and use disorders, which could later on induce psychotic disorders and schizophrenia. Effective strategies combating cannabis dependence and cannabis use disorder (CUD) are therefore warranted. Exercise presents as a low-cost and low-stigma alternative to traditional pharmacotherapy and psychotherapy in the treatment of substance use disorders, which also promotes physical well-being with virtually no side effects. While exercise has some success in treating use disorders of stimulants, alcohol, and tobacco, evidence of its effects on CUD remains scarce. Hence, the present study will be conducted to assess the effectiveness of a 12-week aerobic exercise training regimen on reducing cannabis dependence and the severity of CUD. Participants with cannabis dependence will be randomly assigned to either the exercise or the control group. Participants assigned to the exercise group will partake in a 12-week aerobic exercise training program of vigorous-intensity using indoor bikes, whereas those assigned to the control group will perform sham exercise of very light-intensity on indoor bikes. The 12-week study is divided into three (3) 4-week phases: 1. Intensive Intervention - all participants will exercise twice a week under supervision. 2. Active Intervention - all participants will exercise once a week under supervision. 3. Passive Maintenance - no supervised exercise sessions will be provided. All participants will receive exercise reminders via weekly text messages. Cannabis use-related, cognitive, and physical outcomes will be assessed every 4 weeks, whereas withdrawal symptoms will be assessed and urine quick test administered every week.

First Posted: 2025-07-29

Condition(s): Cannabis Abuse, Cannabis Dependence, Cannabis Use Disorder

Intervention(s): Indoor Cycling, Indoor Cycling

Status: RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: The University of Hong Kong

Principal Investigator:

Completion Date (primary or actual): 2028-12

CT.gov Identifier: NCT07091292

Cannabis for Obesity Trial

The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.

First Posted: 2023-11-18

Condition(s): Obesity

Intervention(s): Cannabis, Placebo

Status: RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Joshua A. Lile, Ph.D.

Principal Investigator: Joshua A. Lile, Ph.D., Professor

Completion Date (primary or actual): 2028-03-31

CT.gov Identifier: NCT06137365

A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease

It is a phase II randomized, parallel, double-blind, placebo-controlled, multi-center clinical trial of the efficacy and safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in patients with Parkinson's disease. The objective of the study is to access the safety and efficacy of WD-1603 carbidopa-levodopa extended-release tablets in patients with Parkinson's disease.

First Posted: 2021-09-05

Condition(s): Parkinson Disease

Intervention(s): WD-1603 Carbidopa-Levodopa Extended-Release Tablets, Placebo

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Shanghai WD Pharmaceutical Co., Ltd.

Principal Investigator:

Completion Date (primary or actual): 2022-12-28

CT.gov Identifier: NCT05036473

Senna Alata Leaf Decoction as a Treatment for Tinea Imbricata

Background: Tinea imbricata ("tokelau") is a rare form of tinea corporis which is caused by Trichophyton concentricum. It is endemic among the T'boli tribe in Sarangani, Philippines . Temporary remissions, despite antifungal treatment, can be attributed to factors such as genetic susceptibility, widespread poverty, poor hygienic conditions and overcrowding. Limited access to commercial antifungal medications makes the treatment of tinea imbricata a pressing public health concern. Senna alata grows abundantly in the areas where the T'boli tribe resides. Anecdotal reports about its efficacy as a treatment for tinea imbricata exist and need to be further validated. Objective: This study aims to assess the efficacy and safety of a community-prepared Senna alata leaf decoction in the treatment of tinea imbricata. Methods: This study is a preliminary open label, before and after clinical trial. Enrolled patients were taught how to make Senna alata leaf decoction and were asked to apply it as a leave-on body wash once a day for 28+/-3 days. Disease severity, pruritus visual analogue scale scores (VAS) and potassium hydroxide smear (KOH) of the skin scrapings were evaluated before and after treatment. Two separate assessors evaluated post treatment severity based on standard photographs. Diagnostic concordance was determined using Cohen's kappa statistics. Wilcoxon paired signed-rank test was used to analyzed before and after clinical parameter scores. Adverse drug events were recorded.

First Posted: 2018-11-19

Condition(s): Tinea Imbricata

Intervention(s): Senna alata leaf decoction

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: Philippine Dermatological Society

Principal Investigator:

Completion Date (primary or actual): 2015-01-15

CT.gov Identifier: NCT03745183

Cannabinol Use in Patients With Insomnia Disorder

This study aims to investigate the acute effects of cannabinol (CBN) 30 mg and 300 mg, versus placebo, on sleep architecture and next-day functioning in adults aged 25-65 years with chronic insomnia disorder.

First Posted: 2022-04-25

Condition(s): Insomnia Disorder

Intervention(s): 30 mg Cannabinol (CBN), 300 mg Cannabinol (CBN), Placebo

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Woolcock Institute of Medical Research

Principal Investigator:

Completion Date (primary or actual): 2023-09-05

CT.gov Identifier: NCT05344170

A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004

The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).

First Posted: 2015-11-26

Condition(s): Parkinson's Disease

Intervention(s): Accordion Pill™ Carbidopa/Levodopa

Status: UNKNOWN

Enrollment (expected or actual): 460

Allocation: NA

Sponsor: Intec Pharma Ltd.

Principal Investigator:

Completion Date (primary or actual): 2019-12

CT.gov Identifier: NCT02615873

Effect of Oxytocin on Craving and Therapy Response

The purpose of this study is to examine the impact of a medication called oxytocin on marijuana use and therapy response in people who frequently use marijuana.

First Posted: 2013-04-09

Condition(s): Marijuana Dependence

Intervention(s): Oxytocin, Saline

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: Aimee McRae-Clark, Associate Professor of Psychiatry

Completion Date (primary or actual): 2016-07

CT.gov Identifier: NCT01827332

Computerized Intervention for Distress Intolerance

This study evaluates the impact of a computerized distress intolerance intervention relative to a control intervention on cannabis use-related behavior and neurophysiology.

First Posted: 2019-11-21

Condition(s): Cannabis Use Disorder

Intervention(s): Computerized Distress Intolerance Intervention, Computerized Healthy Behaviors Intervention

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Auburn University

Principal Investigator: Richard Macatee, Assistant Professor

Completion Date (primary or actual): 2017-10-30

CT.gov Identifier: NCT04173078

Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

This two-phase project seeks to examine the cardiovascular response to consumption of cannabis variants of different cannabinoid composition through different methods (smoking vs. vaporizing), at rest and during aerobic exercise. Multiple measures that have been shown to predict risk factors for chronic-disease and negative health outcomes will be assessed following cannabis consumption at rest or in combination with exercise. These techniques will examine arterial stiffness, vascular function, and cardiac function. In phase I and II, subjects will visit the lab on 6 different occasions; with 1 visit acting as an introductory visit, 1 as an exercise control visit, 2 as resting cannabis visits, and 2 as cannabis + exercise visits. Cannabis used in phase I of this study will consist of approximately 10% THC. On all visits, pulse wave velocity, flow mediated dilation, and echocardiography measures will be performed following cannabis consumption by smoking or vaporizing, and cannabis consumption by smoking or vaporizing followed by 20 minutes of exercise on a cycle ergometer. Phase II of the study will implore a similar design. In favor of altering method of consumption, in all visits cannabis will be consumed by vaporization and will be either a high cannabidiol (CBD: (\~10%)) and low delta-9-tetrahydrocannabinol (THC: (\<1%)), or a high THC (\~10%) and low CBD (\<1%) variant.

First Posted: 2021-01-05

Condition(s): Cannabis, Cardiovascular Risk Factor

Intervention(s): Cannabis, Cannabis, Cannabis, Cannabis

Status: COMPLETED

Enrollment (expected or actual): 22

Allocation: RANDOMIZED

Sponsor: Jamie Burr

Principal Investigator: Jamie Burr, Associate Professor

Completion Date (primary or actual): 2025-04-16

CT.gov Identifier: NCT04693884

A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea

This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.

First Posted: 2018-08-24

Condition(s): Obstructive Sleep Apnea

Intervention(s): THX-110

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: NA

Sponsor: Neurothera Labs Inc.

Principal Investigator:

Completion Date (primary or actual): 2019-04

CT.gov Identifier: NCT03646552

The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles

This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.

First Posted: 2022-11-02

Condition(s): Cannabis Use

Intervention(s): Cannabis, Placebo

Status: RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2027-01

CT.gov Identifier: NCT05602649

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no effective and safe medications approved for the treatment of abdominal pain associated with bowel symptoms in IBS. This study will investigate the effects of an approved medication, Dronabinol, on the movement of food through the stomach and colon in subjects with a history of diarrhea-predominant Irritable Bowel Syndrome (D-IBS). Dronabinol is a synthetic medication (a medication made in a laboratory) related to the active ingredient of "cannabinoid or marijuana". Dronabinol is approved by the Food and Drug Administration (FDA) for preventing nausea and vomiting in patients with cancers undergoing chemotherapy. It is also used in AIDS patients with excessive weight loss for improvement in appetite and weight gain. The hypothesis in this study is that dronabinol will slow down the movement of food through the colon, and that this effect is regulated by the genes controlling the body messengers (receptors) that respond to medicinal marijuana or synthetic medicines that work on the same messengers that are present in the gastrointestinal tract and pain nerves.

First Posted: 2010-12-03

Condition(s): Irritable Bowel Syndrome

Intervention(s): Dronabinol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Mayo Clinic

Principal Investigator:

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT01253408

Cannabis Use and Outcomes in Black and White Patients With Cancer

The goal of the observational study is to learn how black and white patients with solid tumor cancer use cannabis, opioids and tobacco. The investigators are using momentary ecological assessment through a smart phone app and surveys to assess patient-reported pain and other symptoms as to inform clinical practice and guidelines for underrepresented populations.

First Posted: 2023-09-14

Condition(s): Cancer

Intervention(s):

Status: RECRUITING

Enrollment (expected or actual): 600

Allocation:

Sponsor: State University of New York at Buffalo

Principal Investigator: Rebecca Ashare, Co- Principal Investigator

Completion Date (primary or actual): 2027-03-30

CT.gov Identifier: NCT06037681

Brief Voluntary Alcohol and Drug Intervention for Middle School Youth

We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance to test out a voluntary after school program called Project CHOICE, which focuses on helping students decrease their alcohol and drug use. We are conducting surveys in all schools over three years and providing the intervention in 8 schools in the 2008-2009 school year and in the other 8 schools in the 2011-2012 school year. This is a program we have provided before in middle schools and we found that it was effective in curbing alcohol and drug use among students who voluntarily attended and among all students at the intervention school.

First Posted: 2010-03-05

Condition(s): Alcohol Drinking, Cigarette Smoking, Marijuana Smoking

Intervention(s): Project CHOICE

Status: COMPLETED

Enrollment (expected or actual): 6455

Allocation: RANDOMIZED

Sponsor: RAND

Principal Investigator:

Completion Date (primary or actual): 2014-06

CT.gov Identifier: NCT01081119

Use of a Cannabinoids as a Treatment Strategy for Alzheimer's Disease

Brief Summary: The objective of the study is to evaluate the effect of cannabinoids on Alzheimer's Disease. This is a double-blind, randomized, placebo-controlled clinical trial. The study aims to recruit patients of both sexes diagnosed with Alzheimer's Disease who are in the mild and moderate stages for treatment with cannabinoids. The specific objectives of the study are: Primary Outcome * To evaluate the effect of Cannabis sativa at low doses according to the Mini-Mental State Examination (MMSE) scale - Memory and Cognition test - in patients with Alzheimer's Disease. Secondary Outcomes * To evaluate the effect of Cannabis sativa at low doses according to the Cornell scale - Depression in dementia test. * To evaluate the effect of Cannabis sativa at low doses according to the GDS scale - Depression in elderly people test. * To evaluate the effect of Cannabis sativa at low doses according to the QoL scale - Quality of Life test. * To evaluate the effect of Cannabis sativa at low doses according to the Epworth scale - Drowsiness test. * To evaluate the adverse effects of Cannabis sativa at low doses given daily for 26 weeks in patients with Alzheimer's Disease. Participants will use a compound containing CBD/THC 50/5 mg/mL, administered as 0.2 mL once a day. The placebo group will use a compound identical to the treatment but containing only vehicle. To address the questions above, the treated group will be compared with the placebo group over a period of 6 months. Participants will be assessed every 2 months. Additionally, blood and cerebrospinal fluid tests will be conducted to measure specific proteins related to Alzheimer's Disease and inflammatory markers.

First Posted: 2024-08-26

Condition(s): Alzheimer Disease

Intervention(s): Cannabis, Placebo

Status: COMPLETED

Enrollment (expected or actual): 72

Allocation: RANDOMIZED

Sponsor: Federal University of Latin American Integration

Principal Investigator: FRANCISNEY PINTO DO NASCIMENTO, Professor and Coordinator of the Laboratory of Medicinal Cannabis and Psychedelic Science

Completion Date (primary or actual): 2025-03-27

CT.gov Identifier: NCT06570928

Effect of Topical CBD Cream for Degenerative Hallux Disorders

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

First Posted: 2019-09-25

Condition(s): Hallux Valgus, Hallux Rigidus

Intervention(s): magnesium-cannabidiolic acid cream, Placebo cream

Status: TERMINATED

Enrollment (expected or actual): 11

Allocation: RANDOMIZED

Sponsor: Rush University Medical Center

Principal Investigator:

Completion Date (primary or actual): 2023-05-15

CT.gov Identifier: NCT04103814

Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects

Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority. The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects. This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of \[4-14C\]AEF0117 approximately 1 hour after completion of a low fat breakfast.

First Posted: 2022-09-26

Condition(s): Marijuana Abuse

Intervention(s): AEF0117

Status: COMPLETED

Enrollment (expected or actual): 8

Allocation: NA

Sponsor: Aelis Farma

Principal Investigator:

Completion Date (primary or actual): 2023-02-24

CT.gov Identifier: NCT05554926

Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimer's Disease - Alzheimer's Disease and Cannabis Clinical Trial (DAZACANN) Open-Label Phase

Alzheimer's Disease (AD) has become a significant public health issue due to the increase in its incidence from 2.0 to 16.8 cases per thousand people in a year, based on 2022 data. As many countries experience population aging, there is an increase in the prevalence of AD cases, which is the main form of dementia in the elderly. It commonly begins around the age of 60, with aging being the primary risk factor. AD is a neurodegenerative disorder characterized by the presence of extracellular beta-amyloid plaques and intracellular neurofibrillary tangles of Tau protein. Among the main symptoms of AD is progressive memory loss, with varying degrees of cognitive impairment. These symptoms share common clinical features such as a progressive decline in cognitive functions, including abstract thinking, judgment, language, personality changes, and behavioral symptoms, as well as the emergence of certain comorbidities. As there are currently no curative treatments for this disease, pharmacotherapy aims to control the progressive symptoms, improving cognitive and functional aspects in patients, and consequently their quality of life. In this context, there is a need for further research to identify effective drugs that can delay or alleviate symptoms. This study is part of the second phase of the project entitled: Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimer's Disease - Alzheimer's Disease and Cannabis Clinical Trial (DAZACANN): A randomized, double-blind, placebo-controlled clinical trial previously approved by the Human Ethics Committee - CEP (CAAE 60167722.6.0000.0107). The trial is being finalized at the Laboratory of Medicinal Cannabis and Psychedelic Science, located in the city of Foz do Iguaçu, Paraná, and will continue with a new experimental design, now as an open-label trial (all participants will receive the extract and will be informed about the formulation they are receiving). The objective of this study remains to evaluate the clinical and biochemical effects of using cannabinoid-based products with low doses of purified CBD and THC, both individually and in combination, in patients with AD.

First Posted: 2025-07-29

Condition(s): Alzheimer Disease (AD)

Intervention(s): Cannabis 50 mg of CBD and 5 mg of THC

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 61

Allocation: NA

Sponsor: Federal University of Latin American Integration

Principal Investigator: FRANCISNEY PINTO DO NASCIMENTO, University Professor

Completion Date (primary or actual): 2025-12-12

CT.gov Identifier: NCT07091747

Epidiolex® for Anxiety in Pediatric Epilepsy

This is a prospective open label study assessing the efficacy and tolerability of pharmaceutical grade cannabidiol--Epidiolex (R), for the treatment of anxiety in pediatric patients with pediatric epilepsy that has been difficult to treat and requires ongoing use of anticonvulsant medication.

First Posted: 2022-04-12

Condition(s): Anxiety, Epilepsy

Intervention(s): Cannabidiol 100 MG/ML

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Principal Investigator: Jay Salpekar, M.D., Principal Investigator

Completion Date (primary or actual): 2025-05-05

CT.gov Identifier: NCT05324449

Is Medicinal Cannabis an Effective Treatment for Tourette Syndrome in Adolescents? a Pilot Study

This is a single site, pilot double-blind, randomized, placebo-controlled, cross-over study of 10 participants comparing medicinal cannabis (THC:CBD 10:15 oil) with placebo in reducing tics in adolescents aged 12 - 18 years with severe Tourette Syndrome (TS). The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized controlled trial of THC:CBD 10:15 oil to reduce tic severity in adolescents with TS. The secondary objective of this study is to collect preliminary data on the safety of oral THC:CBD 10:15 oil in adolescents aged 12 to 18 years with TS. As an exploratory aim data from clinician- and parent-rated measures will be compared across the phases to explore for a signal of efficacy on primary (tic reduction) and secondary (premonitory urges, obsessive compulsive behaviors, Attention Deficit Hyperactivity Disorder \[ADHD\] symptoms) outcome measures.

First Posted: 2022-01-11

Condition(s): Tourette Syndrome in Adolescence

Intervention(s): Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd., Placebo

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: RANDOMIZED

Sponsor: Murdoch Childrens Research Institute

Principal Investigator:

Completion Date (primary or actual): 2024-01-04

CT.gov Identifier: NCT05184478

Effect Of Nigella Sativa Oil for the Treatment of Hypertension

My research explores the antihypertensive effects of Nigella sativa (black seed) oil in managing high blood pressure. Hypertension is a growing global health concern, often insufficiently controlled by standard medications. Nigella sativa, known for its bioactive compound thymoquinone, possesses antioxidant, anti-inflammatory, and vasodilatory properties, making it a potential natural remedy for blood pressure regulation.

First Posted: 2025-07-09

Condition(s): Hypertension

Intervention(s): Nigella sativa (black seed)

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Superior University

Principal Investigator: Muhammad Naveed Babur, Principal Investigator

Completion Date (primary or actual): 2026-02-28

CT.gov Identifier: NCT07055763

Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

First Posted: 2024-07-03

Condition(s): Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Syndrome, Acute Coronary Syndrome

Intervention(s): Percutaneous Coronary Intervention

Status: UNKNOWN

Enrollment (expected or actual): 382

Allocation:

Sponsor: San Luigi Gonzaga Hospital

Principal Investigator: Enrico Cerrato, Medical Doctor, MD

Completion Date (primary or actual): 2024-10-01

CT.gov Identifier: NCT06484647

Treating South African Pregnant Women for Methamphetamine

The purpose of this study was to develop and initially evaluate an efficacious, comprehensive, culturally sensitive, women-centered model of care for pregnant South African women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC.

First Posted: 2011-06-30

Condition(s): HIV, Drug Addiction

Intervention(s): Psycho-education, Experimental

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: RTI International

Principal Investigator:

Completion Date (primary or actual): 2013-06

CT.gov Identifier: NCT01386138

Alcohol Use Disorder and Cannabidiol

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

First Posted: 2022-11-14

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 180

Allocation: RANDOMIZED

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2027-04

CT.gov Identifier: NCT05613608

Post-traumatic Stress Disorder (PTSD), Addiction, and Virtual Reality

Eligible veterans, National Guardsmen \& Reservists with post-traumatic stress disorder (PTSD) and problems with addiction will be randomly assigned to one of two treatment conditions. All participants will undergo exposure therapy, a gold standard behavioral treatment for PTSD for 10 weeks. In addition to exposure therapy, some participants will be randomly assigned to receive (1) virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use, and (2) cellular phone-based reminders of learning (extinction reminders, or, ERs) to VR exposure (available 24 hours per day/7 days per week) to high-risk contexts for drug use. The main hypothesis is that those participants who receive exposure therapy + VR/ERs will demonstrate less substance use and lower PTSD symptoms during treatment, at post-treatment, and at follow-up than those participants who only receive exposure therapy. At study completion, a total of 123 subjects signed consent.

First Posted: 2010-08-23

Condition(s): Substance Use Disorders, Posttraumatic Stress Disorder

Intervention(s): Prolonged Exposure Therapy, Prolonged Exposure therapy + VR/ER

Status: COMPLETED

Enrollment (expected or actual): 38

Allocation: RANDOMIZED

Sponsor: Duke University

Principal Investigator:

Completion Date (primary or actual): 2013-12

CT.gov Identifier: NCT01186315

Cannabis for Opioid Substitution Trial

The purpose of this study is to define common strains of cannabis that adult chronic cancer and non-cancer pain syndrome patients are using as a replacement for opioids (narcotics). Identified strains, if any, will then be tested via randomized controlled trials to support an application for a Health Canada Drug Identification Number.

First Posted: 2019-03-01

Condition(s): Pain Syndrome, Opioid Use, Cannabis Use

Intervention(s): Medical Cannabis

Status: UNKNOWN

Enrollment (expected or actual): 1200

Allocation:

Sponsor: Cannabis Research Associates

Principal Investigator:

Completion Date (primary or actual): 2019-10-31

CT.gov Identifier: NCT03859089

Perioperative Δ9-THC for Postsurgical Pain

Adequate treatment of postsurgical pain leads to better mobilization, shorter hospital stay, lower costs and higher patient satisfaction. In its treatment, frequent use is made of opioids. However, opioids have many side-effects. A possible add-on can be sought in THC, which has been shown to have possible analgesic and/or pain modulating effects in preclinical research. The purpose of this study is to investigate the analgesic and pain modulating effects of perioperative Namisol, a tablet containing THC, in patients that will undergo major abdominal surgery.

First Posted: 2013-02-13

Condition(s): Pain

Intervention(s): Namisol, Diazepam/placebo

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Radboud University Medical Center

Principal Investigator:

Completion Date (primary or actual): 2014-04

CT.gov Identifier: NCT01790555

Marinol in Trichotillomania or Obsessive Compulsive Disorder

The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The hypothesis to be tested is that dronabinol will be effective and well tolerated in patients with these disorders. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

First Posted: 2010-03-26

Condition(s): Trichotillomania, Obsessive Compulsive Disorder

Intervention(s): Dronabinol

Status: COMPLETED

Enrollment (expected or actual): 14

Allocation: NA

Sponsor: University of Chicago

Principal Investigator:

Completion Date (primary or actual): 2011-02

CT.gov Identifier: NCT01093976

Personalized Health Assessment Related to Medications (Project PHARM)

This research will adapt an evidence based intervention for alcohol and other drugs and evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in a web-based format for use with college students who have misused PSMs.

First Posted: 2017-01-31

Condition(s): Feedback, Psychological, Clinical Trial, Substance Abuse

Intervention(s): Web-based PFI, Assessment Only

Status: COMPLETED

Enrollment (expected or actual): 843

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Jason Kilmer, Associate Professor, School of Medicine: Psychiatry

Completion Date (primary or actual): 2021-12-15

CT.gov Identifier: NCT03037476

Use of Zolpidem in Parkinson's Disease

Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism. The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.

First Posted: 2011-05-10

Condition(s): Parkinson's Disease

Intervention(s): Levodopa, Zolpidem first dose, Zolpidem second dose, sugar pill

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Rush University Medical Center

Principal Investigator: Leonard Verhagen Metman, MD

Completion Date (primary or actual):

CT.gov Identifier: NCT01351168

Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of Nigella Sativa in 84 Hyperlipidaemic patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either Nigella Sativa 500 mg capsule daily or placebo capsule identical to Nigella Sativa twice daily for 8 weeks. Evaluation of lipid profile, SGPT, S.Creatinine will be before and after 8 weeks of intervention. Nigella Sativa related adverse events will be identified. Study outcome will establish safety and efficacy of Nigella Sativa in atorvastatin treated hyperlipidaemic patients

First Posted: 2024-05-21

Condition(s): Hyperlipidemia

Intervention(s): Nigella Sativa capsule 500mg, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 84

Allocation: RANDOMIZED

Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Principal Investigator: Farzana Siddiqua, Resident, MD, Pharmacology

Completion Date (primary or actual): 2024-08-31

CT.gov Identifier: NCT06422650

Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea

This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).

First Posted: 2012-12-21

Condition(s): Sleep Apnea, Obstructive

Intervention(s): Dronabinol, Placebo (for Dronabinol)

Status: COMPLETED

Enrollment (expected or actual): 75

Allocation: RANDOMIZED

Sponsor: University of Illinois at Chicago

Principal Investigator: David W. Carley, Professor

Completion Date (primary or actual): 2016-12-31

CT.gov Identifier: NCT01755091

The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis

There is growing evidence of high rates of substance use disorders among individuals with psychotic disorders especially in young people with predisposition for psychosis. There is some genetic evidence that carriers of the valine158 allele of the catechol-O-methyltransferase (COMT) gene had increased risk to exhibit psychotic symptoms and to develop schizophrenia if they used cannabis by the age of 18. It was also shown that carriers of the COMT val/val genotype were most sensitive to THC-induced psychotic experiences but this was conditional on pre-existing susceptibility to psychosis. The investigators propose to use brain-imaging and molecular genetics to investigate whether genetic factors may contribute to the THC-induced dopamine release and possibly to cannabis- induced psychosis.

First Posted: 2012-03-28

Condition(s): Cannabis Dependence, Psychosis

Intervention(s):

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation:

Sponsor: Hadassah Medical Organization

Principal Investigator: VEINSHTEIN AVIV, Senior Research Fellow

Completion Date (primary or actual): 2014-10

CT.gov Identifier: NCT01565174

Study Comparing Two Types of Psychotherapy for Treating Depression and Substance Abuse

The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans with depressive and substance use disorders.

First Posted: 2005-04-15

Condition(s): Alcohol Abuse, Cannabis Abuse, Major Depressive Disorder, Substance-Related Disorders

Intervention(s): Integrated Cognitive Behavioral Therapy, Twelve Step Facilitation Therapy

Status: COMPLETED

Enrollment (expected or actual):

Allocation: RANDOMIZED

Sponsor: US Department of Veterans Affairs

Principal Investigator:

Completion Date (primary or actual):

CT.gov Identifier: NCT00108407

Healthcare Integrity & Anti-Fraud Enforcement

The PHX-AFK-US Protocol is a coalition-backed regulatory scaffold designed to restore healthcare integrity across U.S. facilities. It targets fraud, kickback schemes, and supply chain opacity through validator governance, smart contract enforcement, and public transparency. Anchored by notarized affidavits, NFT fiscal instruments, and dashboard oversight, this protocol empowers whistleblowers, mobilizes validators, and escalates complaints to federal and state regulators. It integrates secure audit trails, DAO voting logic, and asset freeze triggers to ensure accountability, reform, and systemic trust.

First Posted: 2025-10-16

Condition(s): Healthcare Fraud Schemes, Kickback Networks, Supply Chain Vulnerabilities, Governance Failures, Whistleblower Activation, Regulatory Escalation Pathways, Validator Oversight & DAO Governance, Public Transparency & Auditability

Intervention(s): Validator-Governed Reform & Regulatory Escalation Protocol, Coalition-Grade Validator Dashboard Module (CVDM-1), Coalition-Flagged Pharmaceutical Audit Trigger (CFPAT-1)

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 100

Allocation:

Sponsor: Truway Health, Inc.

Principal Investigator:

Completion Date (primary or actual): 2034-10-13

CT.gov Identifier: NCT07217730

Motivational Interviews for Incarcerated Teens - 1

The purpose of this study is to test the efficacy of an individual motivational interview for reducing alcohol and marijuana-related harm as well as alcohol and marijuana use in incarcerated teens.

First Posted: 2005-09-28

Condition(s): Alcoholic Intoxication, Marijuana Abuse

Intervention(s): Behavior Therapy

Status: COMPLETED

Enrollment (expected or actual): 200

Allocation:

Sponsor: Brown University

Principal Investigator: Lynda Stein, Professor, University of Rhode Island

Completion Date (primary or actual): 2004-07

CT.gov Identifier: NCT00227916

Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder

The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder. In a two-armed, randomized controlled trial the efficacy of self-guided psychological intervention delivered via a mobile app (Nałogometr 2.0) will be assessed. During the course of three months, participants will have access to intervention modules, based mainly on mindfulness and cognitive behavioral therapy (CBT). With the use of ecological momentary assessment (EMA), longitudinal data on several variables related to craving and lapse risk will be collected. Additionally, a questionnaire battery assessment - administered monthly - will measure severity of substance dependence, levels of anxiety, depression, and life satisfaction.

First Posted: 2023-02-15

Condition(s): Substance Use Disorders, Addiction, Alcohol, Addiction, Substance

Intervention(s): Mobile app-based self-guided interventions

Status: UNKNOWN

Enrollment (expected or actual): 400

Allocation: RANDOMIZED

Sponsor: PredictWatch

Principal Investigator:

Completion Date (primary or actual): 2023-06

CT.gov Identifier: NCT05730504

Responsible Marijuana Sales Practices to Reduce the Risk of Selling to Intoxicated Customers

The new recreational marijuana markets are contributing to polysubstance-impaired driving and other harms, especially when marijuana is used in combination with alcohol, by selling marijuana to obviously-intoxicated customers. In this study, the effectiveness of an intervention to reduce the risk of marijuana sales to obviously-intoxicated customers will be tested in the state-licensed recreational marijuana market in Oregon, one of the first states to ban such sales. The intervention will combine efforts by state regulators to increase deterrence of the state law prohibiting marijuana sales to obviously-intoxicated customers with training of store personnel to recognize signs of intoxication and refuse sales. It will also include testing the rate at which visibly intoxicated customers are refused alcohol at nearby establishments that sell alcohol either on-site or off-site

First Posted: 2024-02-01

Condition(s): Alcoholic Intoxication, Automobile Accident, Cannabis

Intervention(s): Policy and Training Intervention, Usual and Customary Policy and Training (UC-PT) (Control) Condition

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 229

Allocation: RANDOMIZED

Sponsor: Klein Buendel, Inc.

Principal Investigator:

Completion Date (primary or actual): 2027-08-31

CT.gov Identifier: NCT06235632

Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa

A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist. Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.

First Posted: 2008-09-26

Condition(s): Anorexia Nervosa

Intervention(s): dronabinol, placebo

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: Odense University Hospital

Principal Investigator: Tine Hylle, for Alin Andries

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT00760695

Clinical Study of in Situ Regeneration of Endometrium

Thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.

First Posted: 2020-01-18

Condition(s): Infertility, Female, of Uterine Origin, Endometrial Fibrosis

Intervention(s): CBD-bFGF, Collagen/BMMNCs, Estrogen

Status: UNKNOWN

Enrollment (expected or actual): 345

Allocation: RANDOMIZED

Sponsor: Yali Hu

Principal Investigator: Yali Hu, Professor，Chief Physician of Obstetrics and Gynecology

Completion Date (primary or actual): 2024-12

CT.gov Identifier: NCT04233892

Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400, 800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when combined with placebo marijuana, as well as its ability to modulate the behavioral effects of active marijuana.

First Posted: 2013-05-01

Condition(s): Smoking, Marijuana

Intervention(s): CBD

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2014-10

CT.gov Identifier: NCT01844687

Accountability for Care Through Undoing Racism & Equity for Moms

This project-also known as "Accountability for Care through Undoing Racism \& Equity for Moms" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support. ACURE4Moms is a pragmatic 4-arm cluster randomized controlled trial conducted with 39 prenatal practices across North Carolina. Practices have been randomly assigned to receive either: Arm 1 (Standard Care): North Carolina Medicaid Care management for high-risk pregnancies; Arm 2 (Data Accountability and Transparency): North Carolina Medicaid Care Management + Practice-level Data Accountability interventions; Arm 3 (Community-Based Doula Support): North Carolina Medicaid Care Management + Community-Based Doula support intervention for high-risk patients during pregnancy and postpartum; or Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): North Carolina Medicaid Care Management + Both Arms 2 and 3 interventions. During each practice's 2-year intervention period, the practice will initiate prenatal care for \~750-1,500 patients (up to 60,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.

First Posted: 2022-08-02

Condition(s): Pregnancy Related, Maternal Health, Maternal Mortality, Low Birthweight, Racism, Implicit Bias

Intervention(s): Data Accountability and Transparency, Community-Based Doula (CBD) Support

Status: RECRUITING

Enrollment (expected or actual): 60000

Allocation: RANDOMIZED

Sponsor: University of North Carolina, Chapel Hill

Principal Investigator:

Completion Date (primary or actual): 2027-08-31

CT.gov Identifier: NCT05484804

The Effects of Cannabidiol on the Driving Ability of Healthy Adults

A randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of CBD on driving ability along with changes in psychological status (i.e. mood, drowsiness, sedation) and cognitive function. Forty healthy West Virginia University (WVU) students will be allocated and randomized to receive: (1) 300 mg of pure CBD oil or (N=20) (2) placebo matched in appearance and taste (N=20). After consuming the study drug, each individual will participate in a 25-35-minute driving simulation and their driving performance measured. To assess changes in psychological status (i.e. mood, drowsiness, sedation) and drug impairment-related cognitive function, the Visual Analog Mood Scale, Stanford Sleepiness Scale , Digital Symbol Substitution Test, Trail Making Test Part A and B, Psychomotor Vigilance Test, and Simple Reaction Time test will also be administered to participants at baseline (prior to study drug consumption) and following completion of the driving simulation test. The entire protocol will be completed in one day and should take 4-4.5 hours to complete for each participant.

First Posted: 2020-10-19

Condition(s): Driving Performance, Cognitive Impairment, Sedation Complication, Mood

Intervention(s): 300 mg Cannabidiol (CBD) oil, Placebo

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: West Virginia University

Principal Investigator: Toni Marie Rudisill, Research Assistant Professor

Completion Date (primary or actual): 2021-12-01

CT.gov Identifier: NCT04590495

4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans

After total joint replacement, early hospital discharge to home (with patients capable of continuing a home-based rehabilitation program) is a cost- effective management strategy. This project will use improved local anesthetic nerve block techniques to enhance technical capability and clinical practice by (i) reducing pain and other morbidities during recovery, (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for earlier return home, and (iii) continued rehabilitation as an outpatient at home when feasible (versus in an extended care facility).

First Posted: 2016-09-08

Condition(s): Pain

Intervention(s): Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone), Bupivacaine Only (control arm)

Status: COMPLETED

Enrollment (expected or actual): 98

Allocation: RANDOMIZED

Sponsor: Brian Williams

Principal Investigator: Brian Williams, VAPHS Surgical Specialties Service Line Medical Director

Completion Date (primary or actual): 2021-08-20

CT.gov Identifier: NCT02891798

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.

First Posted: 2022-07-25

Condition(s): Healthy Volunteers

Intervention(s): levodopa/carbidopa oral formulation A, levodopa/carbidopa oral formulation B

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: RANDOMIZED

Sponsor: University of Minnesota

Principal Investigator:

Completion Date (primary or actual): 2025-08-14

CT.gov Identifier: NCT05471609

Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting

Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration. There is a lack of consensus on the recommended method of donor site management. Donor site morbidity of STSG is usually minimal, but that may not always be the case. Morbidity may include pigmentary abnormalities, prolonged pain and itching, delayed healing, or unfavorable scarring. So, an effort must be taken to find the optimal solution for donor site healing and minimize morbidity. Small portions of the skin graft left at the end of the procedure or the graft pieces obtained after trimming the edges are usually discarded. There have been some studies demonstrating the benefit of the minced residual skin graft on the donor site, possibly resulting in earlier epithelialization and improving the appearance

First Posted: 2024-07-05

Condition(s): Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts

Intervention(s): Minced skin grafts for donor site

Status: UNKNOWN

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: Sohag University

Principal Investigator: Mohamed Abdelmawla Mohamed, principal investigator

Completion Date (primary or actual): 2024-12-01

CT.gov Identifier: NCT06488612

Cannabidiol in Youth Alcohol Use Disorder

The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 50 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month.

First Posted: 2022-04-08

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator:

Completion Date (primary or actual): 2024-06-25

CT.gov Identifier: NCT05317546

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

First Posted: 2021-10-01

Condition(s): Bipolar Disorder, Cannabis Use, Schizoaffective Disorder, Bipolar Type, Bipolar I Disorder, Bipolar II Disorder, Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): Gabapentin, Placebo

Status: COMPLETED

Enrollment (expected or actual): 51

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: James Prisciandaro, Associate Professor

Completion Date (primary or actual): 2026-07-31

CT.gov Identifier: NCT05064319

Safety Trial of Herbal Melanin in Gastritis Patients

The aim of the study is to use Melanole, a herbal extract from Nigella sativa, for treatment of gastritis. The effect of Melanole will be compared between participants (including H. pylori and non-H.pylori infected patients), with the triple therapy and Standard of care treatment of gastritis, respectively. All participants will be examined before and after the administration of Melanole. The results showing a relief of gastritis symptoms for non-H. pylori patients and partial or complete eradication of H. pylori for H.pylori infected patients will be evaluated.

First Posted: 2018-02-09

Condition(s): Acid Dyspepsia, Gastritis

Intervention(s): Herbal Melanin, Nexium, Amoxil, Clarithromycin

Status: UNKNOWN

Enrollment (expected or actual): 132

Allocation: RANDOMIZED

Sponsor: King Abdullah International Medical Research Center

Principal Investigator:

Completion Date (primary or actual): 2020-03

CT.gov Identifier: NCT03428568

Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol is approved for the treatment of nausea in people receiving cancer chemotherapy and as an appetite stimulant in people with AIDS. In some studies, dronabinol reduced the amount of psychological and physical discomfort experienced when people stopped using marijuana. One purpose of our study is to see if people who are on dronabinol have fewer problems with psychological and physical discomfort than those who are on a placebo. In addition to treatment, this research trial will also be measuring the reactions of subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We may examine whether the response to these cues/tasks either predicts treatment outcome, or is affected by your treatment. This information may also help us to understand the ways in which chronic drug use causes changes in our subjects' mental functioning and how those changes respond to treatment. In addition to participation in the treatment research trial, some subjects may be asked to undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI (functional magnetic resonance imaging) in marijuana subjects before and after treatment with the medication dronabinol or with an inactive substance (placebo).

First Posted: 2007-05-31

Condition(s): Marijuana Dependence

Intervention(s): Dronabinol, BRENDA therapy, Placebo

Status: COMPLETED

Enrollment (expected or actual): 61

Allocation: RANDOMIZED

Sponsor: University of Pennsylvania

Principal Investigator: Marina Goldman, Principal Investigator

Completion Date (primary or actual): 2009-07

CT.gov Identifier: NCT00480441

A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients

This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

First Posted: 2013-06-21

Condition(s): Parkinson's Disease

Intervention(s): ND0612, Placebo, Entacapone

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: NeuroDerm Ltd.

Principal Investigator:

Completion Date (primary or actual): 2015-04-26

CT.gov Identifier: NCT01883505

Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact

The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.

First Posted: 2005-09-01

Condition(s): Advanced Idiopathic Parkinson's Disease

Intervention(s): Levodopa-carbidopa intestinal gel (LCIG), CADD-Legacy® 1400 ambulatory infusion pump, percutaneous endoscopic gastrostomy tube (PEG tube), jejunal extension tube (J-tube)

Status: COMPLETED

Enrollment (expected or actual): 77

Allocation: NON_RANDOMIZED

Sponsor: AbbVie (prior sponsor, Abbott)

Principal Investigator:

Completion Date (primary or actual): 2011-04

CT.gov Identifier: NCT00141518

Topical CBD for Musculoskeletal Pain

Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

First Posted: 2021-12-28

Condition(s): Musculoskeletal Pain

Intervention(s): CBD, Control

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: University of Virginia

Principal Investigator: Brent DeGeorge, Assistant Professor of Plastic Surgery

Completion Date (primary or actual): 2022-12

CT.gov Identifier: NCT05170451

Evaluating Responses to Drug-Related Cues Versus Neutral Cues to Understand the Effects of Marijuana Craving - 1

The majority of past research on marijuana treatment has specifically targeted the alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. The purpose of this study is to compare the effects of marijuana-related cues versus non marijuana-related cues in individuals both addicted and not addicted to marijuana. In turn, this may help establish a better understanding of the effects of marijuana cravings and may lead to improved treatments for marijuana dependence.

First Posted: 2005-09-22

Condition(s): Marijuana Abuse

Intervention(s): Cue Desensitization

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation:

Sponsor: Wayne State University

Principal Investigator: Leslie Lundahl, Principal Investigator

Completion Date (primary or actual): 2008-07

CT.gov Identifier: NCT00218478

Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals

Recent research has identified the following withdrawal symptoms to be associated with abruptly stopping marijuana use: anxiety, irritability, bodily aches and pains, and difficulty sleeping. These symptoms resemble those of both depression and nicotine withdrawal, suggesting that a similar treatment drug may be useful. This study will evaluate the effectiveness of two antidepressant drugs, bupropion and nefazodone, in reducing withdrawal symptoms in marijuana dependent individuals.

First Posted: 2005-11-07

Condition(s): Marijuana Abuse

Intervention(s): Nefazodone, Bupropion

Status: COMPLETED

Enrollment (expected or actual): 132

Allocation: RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2004-09

CT.gov Identifier: NCT00249509

Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse

Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

First Posted: 2008-11-25

Condition(s): Schizophrenia, Cannabis Dependence, Continuous

Intervention(s): Motivational therapy, Usual care

Status: COMPLETED

Enrollment (expected or actual): 97

Allocation: RANDOMIZED

Sponsor: Assistance Publique - Hôpitaux de Paris

Principal Investigator:

Completion Date (primary or actual): 2013-04

CT.gov Identifier: NCT00798109

Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease

In patients with Parkinson's disease, the characteristic motor symptoms, i.e., slowness of movement (bradykinesia), tremor and rigidity, are consequences of the progressive degeneration of neurons containing and releasing dopamine. The first-line treatment of Parkinson´s is oral administration of levodopa - a precursor to dopamine that (unlike dopamine) passes the blood brain barrier. After the first few years of treatment with levodopa, many patients do however develop a highly variable response to the drug characterised by rapid shifts between impaired locomotion and drug induced dyskinesias (referred to as the on-off syndrome). This is cased by the marked variation in serum levodopa levels following per oral administration, and it is known that intravenous administration of levodopa give a more stable level of levodopa with improved on-off symptoms. Levodopa-carbidopa intestinal gel (LCIG) - under the name of Duodopa® - is delivered directly to the proximal jejunum via a tube connected to a portable infusion pump. Infusion of Duodopa in the jejunum bypasses gastric emptying, helping to avoid the fluctuation in plasma levodopa levels. However, while clearly confirming that an even administration of levodopa is of considerable benefit to Parkinson patients with on-off symptomatology, the LCIG approach is marred by the need for surgery (for the insertion of the intestinal tube) and various possible complications following this, as well as by side effects such as abdominal pain. Researchers have now succeeded in producing a physiologically acceptable levodopa solution (called Infudopa) in a concentration allowing for a continuous intravenous (i.v.) or subcutaneous (s.c.) administration of therapeutic doses to humans. Early experience of this strategy confirms that both s.c. and i.v. administration of this solution results in even serum levodopa levels and markedly improved motor functioning. The aim of this study is to compare the pharmacokinetic profile of Infudopa administered i.v. and s.c. with that of Duodopa administered enterally in parkinsonian patients with on-off complications.

First Posted: 2018-02-05

Condition(s): Parkinson Disease

Intervention(s): Infudopa i.v., Infudopa s.c., LCIG (Duodopa)

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: RANDOMIZED

Sponsor: Vastra Gotaland Region

Principal Investigator:

Completion Date (primary or actual): 2020-04-20

CT.gov Identifier: NCT03419806

Carbidopa for the Treatment of Nausea and Vomiting in Familial Dysautonomia

This is a pilot clinical trial of carbidopa to treat disabling attacks of nausea and vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive disease in which the growth and development of selective nerves is impaired. Patients with FD suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing, tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have intolerable side sides. Our long-term goal is to treat nausea effectively and without side effects, a therapeutic intervention that would markedly improve the quality of life of patients with FD. The investigators have recently found that resting plasma dopamine levels are high in patients with FD and increase up to 40-fold during nausea and vomiting attacks. This led us to postulate that stimulation of dopamine receptors in the chemoreceptor trigger zone of the brainstem is the likely mechanism of vomiting. Carbidopa is a reversible competitive inhibitor of aromatic L-amino acid decarboxylase (also known as dopa-decarboxylase) that cannot cross the blood brain barrier. It has been used successfully for many years to block the extracerebral synthesis of dopamine and avoid nausea and vomiting in patients with Parkinson's disease taking levodopa. The investigators reasoned that carbidopa could have a similar antiemetic effect in patients with FD. The investigators propose to conduct a pilot trial to assess the safety, tolerability and efficacy of carbidopa for the treatment of nausea in patients with FD. The pilot trial will recruit 25 patients with FD who complain of severe nausea that affects their quality of life. The trial will be divided into two consecutive, but independent parts. Part 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Part 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design. The investigators hope to demonstrate that carbidopa is a safe, well-tolerated drug that blocks the peripheral formation of dopamine and thus prevents dopamine-induced nausea and vomiting attacks in patients with FD.

First Posted: 2010-09-30

Condition(s): Familial Dysautonomia

Intervention(s): Carbidopa, Placebo

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): 2012-10

CT.gov Identifier: NCT01212484

Common Noradrenergic Mechanisms in Parkinson´s Disease and L-DOPA Induced Dyskinesia

The aims of this proposal include tests of hypotheses of the pathogenetic mechanisms of noradrenergic neurotransmission in Parkinson's disease in vivo, using positron emission tomography of patients with early and advanced Parkinson's disease with or without 3,4 L-dihydroxyphenylalanine (L-DOPA) - induced dyskinesia or co-morbid depression, and evaluation of whether these mechanisms can be influenced therapeutically. Hypotheses: 1. The investigators argue that release in human cortical and subcortical brain regions of norepinephrine (NE) derived from metabolism of exogenousL-DOPA is greater in Parkinson's disease patients with L-DOPA- induced dyskinesia than in patients without this complication. This hypothesis will be tested by measuring antagonist \[11C\]yohimbine binding to alpha-2 adrenoceptors before and after L-DOPA challenge. 2. If so, it is argued that the greater rise of norepinephrine, measured as \[11C\]yohimbine displacement after L-DOPA challenge, is the result of down-regulation or loss of norepinephrine transporters. This hypothesis will be tested by measuring the binding of \[11C\]MeNER, a tracer of norepinephrine transporters. 3. If so, the investigators argue that the greater decline of \[11C\]MeNER binding is significantly correlated to the symptoms of Parkinson's disease, as proof that patients with more severe loss of noradrenergic terminals exhibit more severe motor deficits.

First Posted: 2015-10-19

Condition(s): Parkinson´s Disease

Intervention(s): L-DOPA

Status: UNKNOWN

Enrollment (expected or actual): 45

Allocation:

Sponsor: Aarhus University Hospital

Principal Investigator: Adjmal Nahimi, MD, PhD

Completion Date (primary or actual): 2016-01

CT.gov Identifier: NCT02578849

Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients

The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient study,looking at the clinical treatment of cannabis use disorder. The treatment study is a total of 12 weeks. There will be two options offered to participants for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2) patients who cannot complete the inpatient phase due to work or other obligations will complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis use disorder will be enrolled into either the inpatient/outpatient or only outpatient study. This combined design will provide a comprehensive understanding of clonazepam's effects on individuals with cannabis use disorder across a range of outcome measures while also testing the medication's ability to prevent relapse in cannabis-abstinent patients.

First Posted: 2016-09-26

Condition(s): Cannabis Use Disorder

Intervention(s): Clonazepam, Placebo

Status: COMPLETED

Enrollment (expected or actual): 68

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: John Mariani MD, research psychiatrist

Completion Date (primary or actual): 2020-06

CT.gov Identifier: NCT02913924

Contamination of Young Children Hair During Acute Cannabis Intoxication

Hair analysis in pediatric cannabis intoxication is limited by possible sudoral self-contamination, especially in young children due to hair porosity. However, adult studies show no THC-COOH in sweat, challenging this hypothesis. THC-COOH presence in sweat has to this day never been studied in young children. Its absence would help assess the reliability of hair testing for prior exposure. Thus, our main objective is to describe whether THC-COOH can be detected in sweat following cannabis intoxication using gold standard techniques.

First Posted: 2026-04-13

Condition(s): Cannabis Intoxication in Children

Intervention(s): sudoral and hairing sampling

Status: RECRUITING

Enrollment (expected or actual): 15

Allocation: NA

Sponsor: University Hospital, Toulouse

Principal Investigator:

Completion Date (primary or actual): 2028-04-15

CT.gov Identifier: NCT07524088

Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.

First Posted: 2009-04-27

Condition(s): Parkinson Disease, Dyskinesias

Intervention(s): levodopa/carbidopa

Status: COMPLETED

Enrollment (expected or actual): 5

Allocation: NON_RANDOMIZED

Sponsor: Uppsala University

Principal Investigator:

Completion Date (primary or actual): 2008-05

CT.gov Identifier: NCT00888186

Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use

This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption.

First Posted: 2020-12-09

Condition(s): Alcohol Drinking, Alcohol Use, Unspecified, Alcohol Abstinence, Alcohol-Related Disorders

Intervention(s): Endourage 1200 mg OMD ™ Oral Mucosal Drops, Isolate, Placebo, Peppermint Oil, masking flavor

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Endourage, LLC

Principal Investigator:

Completion Date (primary or actual): 2027-01-31

CT.gov Identifier: NCT04659278

Investigating the Effect of Dronabinol on Post-surgical Pain

This study is designed to investigate the effect of dronabinol on post operative pain in patients undergoing total knee replacement (for their own clinical care).

First Posted: 2019-09-23

Condition(s): Knee Replacement, Arthropathy of Knee

Intervention(s): Dronabinol 5mg Cap, Non-active comparator

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Diana Martinez, Psychiatrist II

Completion Date (primary or actual): 2027-08-30

CT.gov Identifier: NCT04099355

Perceptual Influences From Smoking Cannabis: an Experimental Study

The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate. We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.

First Posted: 2024-09-19

Condition(s): Cannabis Use, Stress

Intervention(s): Water Temperature Variation - WW, Water Temperature Variation - CW

Status: RECRUITING

Enrollment (expected or actual): 166

Allocation: RANDOMIZED

Sponsor: University of Colorado, Boulder

Principal Investigator: Carillon Skrzynski, Research Assistant Professor

Completion Date (primary or actual): 2029-07-31

CT.gov Identifier: NCT06588582

Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs, in Parkinson's Disease

The aim of the study is to evaluate if patients' personality could be considerate as predictive factor of quality of life after the establishment of continuous infusion of dopaminergic treatments to observe if there are predictive personality's profiles of specific therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or continuous infusion).

First Posted: 2019-01-04

Condition(s): Parkinson Disease

Intervention(s): TCI scale, PDQ-39 scale

Status: UNKNOWN

Enrollment (expected or actual): 60

Allocation:

Sponsor: University Hospital, Toulouse

Principal Investigator:

Completion Date (primary or actual): 2021-06-18

CT.gov Identifier: NCT03793491

Cannabidiol in Opioid Use Disorder and Chronic Pain

This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone. With a duration of approximately 4 weeks, participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, CBD, will be administered, separated by at least 72 hours to limit carryover effects.

First Posted: 2020-10-14

Condition(s): Chronic Pain, Opioid Use Disorder

Intervention(s): 400 mg Cannabidiol, 800 mg Cannabidiol, 1200 mg Cannabidiol, Beta carotene oral solution without CBD

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Joao De Aquino, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2025-03-19

CT.gov Identifier: NCT04587791

NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers

This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-75 years of age with cancer related pain.

First Posted: 2021-03-22

Condition(s): Cancer Related Pain

Intervention(s): NanaBis™, Oxycodone CR, Placebo Spray, Placebo Tablet, Oxycodone IR

Status: UNKNOWN

Enrollment (expected or actual): 360

Allocation: RANDOMIZED

Sponsor: Medlab Clinical

Principal Investigator:

Completion Date (primary or actual): 2024-06

CT.gov Identifier: NCT04808531

Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones

In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones. After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite increasing experience and success with the procedure, occur in 4% to 24% of patients. Gallbladder stone, pneumobilia and many other various factors are known to be associated with CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It is natural that small stone fragments left after lithotripsy may act as nidi for stone recurrence. Small remaining stone could not be completely detected only using ERCP stone removal and remaining stone removal can reduce residual and recurrent stones. Saline irrigation was effective immediately after ERCP stone removal to remove remaining small stones. Saline irrigation has many advantages such as easy to treatment during ERCP stone removal, almost no additional cost and rare side effect. This study The authors expect this study is a remarkable role of ERCP stone removal procedure.

First Posted: 2011-08-29

Condition(s): Common Bile Duct Gallstones

Intervention(s): Normal Saline Irrigation

Status: UNKNOWN

Enrollment (expected or actual): 160

Allocation: RANDOMIZED

Sponsor: Seoul National University Hospital

Principal Investigator: Sang Hyub Lee, Assistant Professor of Internal Medicine, Seoul National University Bundang Hospital

Completion Date (primary or actual): 2012-12

CT.gov Identifier: NCT01425177

Short-term Effects of TOLCAPONE on Transthyretin Stability in Subjects With Leptomeningeal TTR Amyloidosis (ATTR)

The purpose of this study is to determine whether Tolcapone crosses from the blood stream into the fluid around the brain and stabilizes the protein that makes leptomeningeal amyloid. Tolcapone is a commercially available generic drug that treats Parkinson's disease. The Investigator plans to evaluate Tolcapone as a treatment for ATTR (Transthyretin Amyloidosis), a rare genetic disease often causing death within 5-15 years after diagnosis. ATTR is characterized by deposition of misfolded protein known as amyloid, in one or more organ systems (including the peripheral and autonomic nervous systems, the heart, the brain and the eyes). The age at which symptoms begin to develop varies widely ranging between 20 to 70 years old. ATTR is progressive, and some variants can have a fatal outcome within a few years of presentation. Treatment options include supportive and symptomatic care that may slow or stop progressive decline in functional state but do not alter the pathological process. Liver transplant can be performed in selected patients but is limited by organ supply, requires lifelong immunosuppression, and may be complicated by progressive heart and nerve amyloid deposition. Importantly, liver transplant does not alter the natural course of central nervous system amyloid disease. To date, no treatment for ATTR penetrates the CNS. At present there is no FDA approved treatment for ATTR amyloidosis in the US. In Europe, Tafamidis has been approved for treatment of stage 1 ATTR-polyneuropathy since 2012. Tafamidis and Tolcapone bind to the thyroxine binding site of TTR (with different drug-transthyretin interactions) and in so doing stabilizes the tetrameric form of TTR, preventing dissociation and amyloid fibril formation The preclinical and clinical data from a variety of experimental systems support the therapeutic activity of TOLCAPONE in TTR mediated disease.

First Posted: 2018-07-19

Condition(s): Transthyretin Amyloidosis, Amyloidosis, Leptomeningeal, Transthyretin-Related

Intervention(s): Tolcapone

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: Boston University

Principal Investigator: John L. Berk, Associate Professor,Dept of Medicine, Amyloidosis Center

Completion Date (primary or actual): 2019-04-26

CT.gov Identifier: NCT03591757

Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction

The purpose of this study is to assess how Cannabidiol (CBD) impacts the effectiveness of oral contraceptive (birth control) pills and if CBD changes the possible side effects of birth control pills when CBD and birth control pills are taken at the same time. This study explores the potential interaction between CBD and birth control pills by assessing serum levels of the contraceptive steroid hormones ethinyl estradiol and levonorgestrel in birth control pill users when they also use CBD.

First Posted: 2020-05-21

Condition(s): Contraception

Intervention(s): Cannabidiol Oil, Placebo, Combined oral contraceptive pill

Status: COMPLETED

Enrollment (expected or actual): 9

Allocation: RANDOMIZED

Sponsor: Oregon Health and Science University

Principal Investigator: Shaalini Ramanadhan, Clinical Instructor

Completion Date (primary or actual): 2022-03-02

CT.gov Identifier: NCT04396730

Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis

Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Several previous studies have suggested people with MS using medical marijuana have lower levels of physical disability and improved walking abilities. A major limitation of these previous studies is that the investigators used subjective measures of motor function. In this proposed observational case-control study the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.

First Posted: 2016-09-13

Condition(s): Multiple Sclerosis

Intervention(s): Medical Marijuana

Status: COMPLETED

Enrollment (expected or actual): 22

Allocation:

Sponsor: Colorado State University

Principal Investigator: Thorsten Rudroff, Assistant Professor

Completion Date (primary or actual): 2017-10

CT.gov Identifier: NCT02898974

Alcohol and Cannabis Use Among Pregnant Slovenian Women

The aim of the study is to determine the prevalence of alcohol and drug use among Slovenian pregnant women. Alcohol and drug use during pregnancy has significant effects on the foetus and has short- and long-term health consequences. One of the most serious consequences is foetal alcohol syndrome, which is characterised by congenital anomalies, cognitive impairment and growth deficits. The prevalence of alcohol and drug use during pregnancy will be investigated in collaboration with the National Institute of Public Health, the Institute of Forensic Medicine of the Faculty of Medicine, University of Ljubljana, Institute Jozef Stefan and the Clinical Department of Neonatology of the Paediatric Clinic, University Clinical Centre Ljubljana, using two different methods. A cross-sectional study will be conducted on a nationally representative sample of meconium samples. Meconium samples will be collected from maternity hospitals in Slovenia. Biomarkers for alcohol and illicit drugs will be determined in the meconium samples. Meconium samples will be collected anonymously. National survey on the lifestyle will be conducted in Slovenian maternity hospitals, including questions on alcohol and drug use during pregnancy. The survey will be anonymous and not related to meconium sampling; participation in the survey will be voluntary. Data linkage between questionnaire responses and meconium analysis will be performed only within the additional subgroup of participants who provided informed consent. Meconium samples that will test positive for either alcohol of cannabis will be analysed for microbiome. For every positive meconium sample, two negative samples will be analysed.

First Posted: 2026-03-06

Condition(s): Microbiome Analysis, Drug Abuse in Pregnancy, Alcohol Abuse in Pregnancy, Health Behavior, Risky

Intervention(s):

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 600

Allocation:

Sponsor: University Medical Centre Ljubljana

Principal Investigator: Jana Lozar Krivec, Assistant professor, PhD, consultant in pediatrics and neonatology

Completion Date (primary or actual): 2026-09

CT.gov Identifier: NCT07456579

Assessment of the Symbiotic Fermented Milk in Patients With Irritable Bowel Syndrome

This study evaluates the effect of a symbiotic fermented milk on health-related quality of life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant IBS.

First Posted: 2015-03-18

Condition(s): Irritable Bowel Syndrome

Intervention(s): LCA symbiotic fermented milk, heat-treated fermented milk

Status: COMPLETED

Enrollment (expected or actual): 76

Allocation: RANDOMIZED

Sponsor: Clinres Farmacija d.o.o.

Principal Investigator:

Completion Date (primary or actual): 2013-01

CT.gov Identifier: NCT02391220

Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users

This study will evaluate the impact of regular use of cannabis on the spatial sensitivity of magnocellular system (visual event-related potential, visual ERP). Secondary purposes of this study are to evaluate the impact of regular use of cannabis on the temporal sensitivity of magnocellular system (visual event-related potential), on the dynamics of cortical visual processing during face perception test (visual event-related potential) and on functioning of retinal photopic and scotopic systems (electroretinogram). The ancillary study is a genetic analysis of a group of candidate genes that aims to identify biomarkers for changes in visual processing. This will allow to distinguish among more homogeneous and specific groups in future studies on larger cannabis user population. This ancillary study concerns all participants subject to their informed consent (facultative study).

First Posted: 2016-08-12

Condition(s): Cannabis Use

Intervention(s): Electroretinography, Contrast sensitivity test during Electroencephalography, Visual simultaneity test during Electroencephalography, Face perception test during Electroencephalography, CAST (cannabis abuse screening test), PANSS (Positive And Negative Symptoms Scale) test, Delayed Matching to Sample (DMS) test, Spatial Working Memory (SWM) test, Rapid Visual Information Processing (RVP) test, Test for attentional performance (TAP) / Divided Attention, Collection of saliva sample

Status: COMPLETED

Enrollment (expected or actual): 163

Allocation: NON_RANDOMIZED

Sponsor: Central Hospital, Nancy, France

Principal Investigator:

Completion Date (primary or actual): 2019-06

CT.gov Identifier: NCT02864680

Turmeric, Black Seeds, Flaxseed and Medicago Sativa in Knee Osteoarthritis

This study investigates the safety and combined effect of Turmeric, Black Seeds, Flaxseed, and Medicago Sativa for relieving symptoms of knee osteoarthritis compared to the placebo group.

First Posted: 2023-02-10

Condition(s): Knee Osteoarthritis

Intervention(s): Cream, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Tabriz University of Medical Sciences

Principal Investigator: Dr. Saeid Safiri, Principal Investigator

Completion Date (primary or actual): 2024-09-01

CT.gov Identifier: NCT05723458

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

The goal of this observational cohort study is to assess the yield of preoperative endoscopic ultrasound focussed on lymph nodes in patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma. The main questions it aims to answer is: 1. The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition 2. Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy

First Posted: 2023-01-10

Condition(s): Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Common Bile Duct Neoplasms, Cholangiocarcinoma, Adenocarcinoma

Intervention(s): Endoscopic Ultrasound registration

Status: COMPLETED

Enrollment (expected or actual): 245

Allocation:

Sponsor: Erasmus Medical Center

Principal Investigator: Dr. L.M.J.W. (Lydi) van Driel, Gastroenterologist, MD, PhD

Completion Date (primary or actual): 2025-08-01

CT.gov Identifier: NCT05678218

CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)

The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.

First Posted: 2022-10-03

Condition(s): Temporomandibular Disorder, Myofascial Pain, Orofacial Pain, CBD, Bruxism

Intervention(s): 5% polymer gel with CBD application, 10% polymer gel with CBD application, Placebo intervention

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Medical University of Silesia

Principal Investigator:

Completion Date (primary or actual): 2023-08-30

CT.gov Identifier: NCT05562635

Use of Cannabis Oil in Fibromyalgia

Recently, medical cannabis has been shown to be effective in chronic pain conditions such as osteoarthritis, neuropathic pain, and other chronic non-cancer pain. A study showed that fibromyalgia patients who use cannabis report significant improvement in pain symptoms and quality of life. Patients reported a 50% reduction in pain, and many also reported improvements in sleep and overall well-being. Further research found that the use of medical cannabis among patients with fibromyalgia led to significant improvements in pain, sleep quality, and overall quality of life. This study emphasized that adverse effects were generally mild and tolerable. Furthermore, the systematic review by Fitz et al. concluded that cannabis may be effective in treating fibromyalgia, with preliminary evidence indicating improvements in pain and sleep disturbances. However, it also highlighted the need for further randomized controlled trials to confirm these findings and determine how the cannabinoid system interacts with the pain pathway. Considering that medical cannabis is effective in treating a variety of symptoms, including pain, cachexia and wasting, sleep disorders, severe or persistent muscle spasms, reduced fatigue in multiple sclerosis, chemotherapy-induced nausea, convulsive disorders, post-traumatic stress disorder, and other conditions in palliative and end-of-life care; with this study, given the premises of the effects of medical cannabis, the aim is to analyze its use also in chronic pain as the main symptom of fibromyalgia syndrome.

First Posted: 2025-09-26

Condition(s): Fibromyalgia, Pain Management, Cannabis, Retrospective Studies

Intervention(s): Use of cannabis oil

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 65

Allocation:

Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Principal Investigator:

Completion Date (primary or actual): 2025-12-31

CT.gov Identifier: NCT07194018

Investigating the Effects of Nabilone on Endocannabinoid Metabolism

The purpose of this study is to learn about the effects of a cannabis-like substance, nabilone, on the levels of endocannabinoid enzyme fatty acid amide hydrolase (FAAH) in brain of healthy individuals. Using magnetic resonance imagine (MRI) and positron emission tomography (PET), the main questions we aim to answer are: 1) Does nabilone decrease levels of FAAH in the brain? and 2) Are changes in levels of FAAH associated with clinical response to nabilone? Participants will complete: * An in-person interview (\~4 hours) * Two brain imaging scanning sessions (\~11 hours) * A one week 2 mg titrated dose of nabilone * Virtual check-ins (up to \~1.5 hours)

First Posted: 2023-06-02

Condition(s): Healthy

Intervention(s): Nabilone Oral Capsule

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2025-12-05

CT.gov Identifier: NCT05885685

A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS

This is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.

First Posted: 2026-07-27

Condition(s): Lennox-Gastaut Syndrome

Intervention(s): Cannabidiol Oral Solution

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 40

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2028-12-28

CT.gov Identifier: NCT07728097

Symptom Tracking in Long COVID Patients Using Formula C™ Sublingual Drops

This is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with Long COVID. Participants 21 and older will take Formula C™ for 90 days. During that time, participants will answer weekly surveys to track symptoms and wellbeing.

First Posted: 2023-12-11

Condition(s): Long COVID, Long Covid19, Post-Acute COVID-19, Post-Acute COVID-19 Syndrome, Long Haul COVID, Long-Haul COVID-19

Intervention(s): Endourage Targeted Wellness Formula C™, a full hemp flower extract

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation:

Sponsor: Endourage, LLC

Principal Investigator:

Completion Date (primary or actual): 2025-01-31

CT.gov Identifier: NCT06163690

CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients

The CANPAIN study has been devised to evaluate the efficacy and safety of a defined cannabis based medicinal product (CBMP) delivered by inhalation to patients with non cancer chronic pain attending a private clinic. CANPAIN is a pragmatic non-randomised, non-blinded real-world trial of the safety, tolerability and effectiveness of a cannabis based medicinal product (CBMP) for the treatment of chronic non-cancer pain compared against matched controls receiving standard of care pain management. CANPAIN will run for 3 years with a minimal planned sample size of 5000 participants per group who have completed at least 12 months of treatment. CANPAIN will be an MHRA and REC approved study. (See Appendix 1 of the Feasibility Study for the full draft protocol of the CANPAIN Study) Prior to commencing the CANPAIN study, the sponsor proposes to conduct a feasibility study. This study will aid in establishing likely rates of patient recruitment, duration of participant enrolment in the study, the demographic and geographic spread of patients, patient acceptability of data collection and identify any issues with technological and drug delivery logistics.

First Posted: 2022-03-18

Condition(s): Chronic Pain

Intervention(s): Cannabis

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: NA

Sponsor: Harley Street (CPC) Limited

Principal Investigator:

Completion Date (primary or actual): 2022-06-30

CT.gov Identifier: NCT05288010

Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.

The present randomized, controlled, parallel-grouped trial includes 48 patients (aged 18 to 75 years) suffering from oral potential premalignant lesions. Patients will be randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)

First Posted: 2017-07-06

Condition(s): Premalignant Lesion

Intervention(s): Nigella sativa buccal tablets 10mg, Nigella sativa buccal tablets 5mg, Placebo buccal tablets

Status: COMPLETED

Enrollment (expected or actual): 48

Allocation: RANDOMIZED

Sponsor: Cairo University

Principal Investigator: Ghada Nabil, Assistant lecturer

Completion Date (primary or actual): 2020-03-12

CT.gov Identifier: NCT03208790

QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication

QTc: Since the reports of three deaths attributed to Torsade de Point (TdP) related to treatment with the long-acting methadone derivative levomethadyl acetate HCl (LAAM), methadone has been scrutinized for any possible association with TdP. Since then, several studies among Methadone Maintenance Treatment (MMT) patients and chronic pain patients were done, reporting diverse results about possible association between methadone dose and QTc prolongation. Most studies however were cross-sectional and generally found insignificant clinical prolongation of QTc. A follow up studies are of importance, and although few studies have started evaluating QTc among MMT patients, none was done among chronic pain patients with no history of drug usage. One study of 8 chronic pain patients experiencing insufficient pain control or intolerable side effects during treatment with oral morphine switched to oral methadone showed insignificant modest increase QTc following 9 month. Perceived Sleep: Chronic pain patients as well as drug addicts are known to suffer from poor sleep. Some studies found possible relation to methadone dose, however, no causal association was found and importantly some also found association with duration of opiate usage before starting methadone when entry to MMT clinic. Thus, patients with no history of opiate addiction are an important interesting group that may help understand relation between methadone usage and sleep quality. However, sleep must be evaluate before opiate administration and a follow up study is needed

First Posted: 2009-10-21

Condition(s): Chronic Pain

Intervention(s): Methadone

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: NA

Sponsor: Tel-Aviv Sourasky Medical Center

Principal Investigator:

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT00999440

A Study of Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will be randomized in a 4:1 ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using GWP42003-P.

First Posted: 2015-11-18

Condition(s): Epilepsy

Intervention(s): GWP42003-P, Placebo

Status: COMPLETED

Enrollment (expected or actual): 35

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2018-10-02

CT.gov Identifier: NCT02607891

A Comparison of Adolescent Group Therapy and Transitional Family Therapy for Adolescent Alcohol and Drug Abusers

The purpose of this study is to compare the effectiveness of two psychosocially-based, manual-driven, behavioral modalities. One of these is a standardized version of the established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational and therapeutic components. The other is a state-of-the-art family therapy approach, Transitional Family Therapy (TFT), which integrates management of the current problem with exploration of multigenerational issues. Both approaches have been developed to expressly target adolescent alcohol problems.

First Posted: 2007-06-08

Condition(s): Alcohol Abuse, Alcohol Dependence, Cannabis Abuse, Cannabis Dependence, Other Substance Abuse

Intervention(s): Adolescent group therapy, Transitional family therapy

Status: UNKNOWN

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: The Morton Center, Inc.

Principal Investigator:

Completion Date (primary or actual): 2012-08

CT.gov Identifier: NCT00484367

Pharmacokinetic Study in Healthy Volunteers

Phase I open, randomized cross-over pharmacokinetic study.

First Posted: 2015-09-18

Condition(s): Parkinson's Disease

Intervention(s): levodopa, carbidopa, ODM-104, levodopa, carbidopa, entacapone

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation: RANDOMIZED

Sponsor: Orion Corporation, Orion Pharma

Principal Investigator:

Completion Date (primary or actual): 2015-11

CT.gov Identifier: NCT02554734

Nabilone for Agitation in Frontotemporal Dementia

The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.

First Posted: 2023-02-24

Condition(s): Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant, Primary Progressive Aphasia, bvFTD, PPA, FTD

Intervention(s): Nabilone, Placebo

Status: TERMINATED

Enrollment (expected or actual): 3

Allocation: RANDOMIZED

Sponsor: Simon Ducharme, MD

Principal Investigator: Simon Ducharme, MD, Associate Professor, McGill University

Completion Date (primary or actual): 2025-12-31

CT.gov Identifier: NCT05742698

An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.

First Posted: 2015-09-09

Condition(s): Tuberous Sclerosis Complex, Seizures

Intervention(s): GWP42003-P

Status: COMPLETED

Enrollment (expected or actual): 199

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2021-06-11

CT.gov Identifier: NCT02544750

Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics

To investigate the effect of rising oral single-doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of immediate release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) or with a single-dose of Sinemet® 100/25 plus a single-dose of entacapone (Comtan®) 200 mg and to assess the tolerability and safety of rising single oral doses of BIA 6-512 when administered in combination with a single-dose of Sinemet® 100/25 or with a single-dose of Sinemet® 100/25 plus a single-dose of Comtan® 200 mg.

First Posted: 2017-03-27

Condition(s): Parkinson Disease

Intervention(s): Placebo oral capsule, Sinemet® 100/25, Comtan®, BIA 6-512 25 mg, BIA 6-512 100 mg

Status: COMPLETED

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2005-02-28

CT.gov Identifier: NCT03091868

Cannabidiol in Children With Refractory Epileptic Encephalopathy

This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period.

First Posted: 2017-01-19

Condition(s): Epileptic Encephalopathy

Intervention(s): CanniMed® 1:20

Status: UNKNOWN

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: University of Saskatchewan

Principal Investigator: Richard Huntsman, MD

Completion Date (primary or actual): 2023-12-31

CT.gov Identifier: NCT03024827

Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS)

This study investigates the effectiveness of a medicinal cannabis extract (NTI164) with 0.08% THC in treating children with pediatric acute-onset neuropsychiatric syndrome (PANS) over a period of 18 to 54 weeks. Participants, aged 18 to 54, will start with a daily dose of 5mg/kg, gradually increasing to a maximum of 20mg/kg over four weeks. After reaching their maximum tolerated dose, they will maintain this dose for eight weeks, with an option to extend up to 54 weeks. The study will measure the treatment\'s efficacy using questionnaires on emotional and behavioral changes, and verify the results with whole blood RNA sequencing to assess immune dysfunction.

First Posted: 2024-10-01

Condition(s): PANS Pediatric Acute-Onset Neuropsychiatric Syndrome

Intervention(s): NTI164

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: NA

Sponsor: Fenix Innovation Group

Principal Investigator:

Completion Date (primary or actual): 2025-12-01

CT.gov Identifier: NCT06621888

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening

First Posted: 2012-02-09

Condition(s): Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Aplastic Anemia, Burkitt Lymphoma, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Congenital Amegakaryocytic Thrombocytopenia, Diamond-Blackfan Anemia, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Paroxysmal Nocturnal Hemoglobinuria, Peripheral T-cell Lymphoma, Polycythemia Vera, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Primary Myelofibrosis, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Secondary Myelofibrosis, Severe Combined Immunodeficiency, Severe Congenital Neutropenia, Shwachman-Diamond Syndrome, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Waldenstrom Macroglobulinemia, Wiskott-Aldrich Syndrome

Intervention(s): fludarabine phosphate, melphalan, total-body irradiation, tacrolimus, mycophenolate mofetil, methotrexate, laboratory biomarker analysis, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation

Status: COMPLETED

Enrollment (expected or actual): 94

Allocation: NA

Sponsor: Roswell Park Cancer Institute

Principal Investigator:

Completion Date (primary or actual): 2019-08-29

CT.gov Identifier: NCT01529827

Neurobiological Drivers of Mobility Resilience: The Dopaminergic System

Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that \~20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

First Posted: 2020-03-27

Condition(s): Parkinsonian Signs in Older Persons

Intervention(s): carbidopa

Status: COMPLETED

Enrollment (expected or actual): 14

Allocation: NA

Sponsor: University of Michigan

Principal Investigator: Nicolaas Bohnen, MD, PhD, Principal Investigator

Completion Date (primary or actual): 2022-06-30

CT.gov Identifier: NCT04325503

Project RAP: Reaching Adolescents for Prevention

The purpose of the study is to determine if a brief motivational interview in the context of an emergency health care visit will reduce high-risk drinking and drug-taking and associated health consequences among adolescents ages 14-21 years old.

First Posted: 2005-09-16

Condition(s): Alcohol Related Morbidity, Alcohol Dependence

Intervention(s): Brief Motivational Intervention, Assessment and list of resources, Referral to Community Resources

Status: UNKNOWN

Enrollment (expected or actual): 1400

Allocation: RANDOMIZED

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Principal Investigator:

Completion Date (primary or actual): 2009-12

CT.gov Identifier: NCT00183157

Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors

The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.

First Posted: 2009-05-21

Condition(s): Parkinson Disease

Intervention(s): levodopa/carbidopa, entacapone, tolcapone

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: RANDOMIZED

Sponsor: Uppsala University

Principal Investigator:

Completion Date (primary or actual): 2009-11

CT.gov Identifier: NCT00906828

Effect of PP-01 on Cannabis Withdrawal Syndrome

This study will be a randomized, double-blind, placebo-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe Cannabis Use Disorder (CUD). The study will enroll approximately 225 participants with moderate to severe CUD and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. Participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).

First Posted: 2022-08-10

Condition(s): Cannabis Withdrawal

Intervention(s): PP-01 High Dose, PP-01 Low Dose, Placebo, Nabilone, Gabapentin

Status: COMPLETED

Enrollment (expected or actual): 234

Allocation: RANDOMIZED

Sponsor: PleoPharma, Inc.

Principal Investigator:

Completion Date (primary or actual): 2023-08-21

CT.gov Identifier: NCT05494437

A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty

Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects. In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.

First Posted: 2020-10-14

Condition(s): Pain, Joint, Pain, Postoperative, Total Knee Arthroplasty

Intervention(s): CBD, Mineral Oil, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 92

Allocation: RANDOMIZED

Sponsor: Rothman Institute Orthopaedics

Principal Investigator:

Completion Date (primary or actual): 2021-05-28

CT.gov Identifier: NCT04585230

Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy

The aim of this study is to assess the effect of LCIG (levodopa-carbidopa intestinal gel) on HRQL (Health-Related Quality of Life) of participants and compare the Health-Related Quality of Life between participants continuing to levodopa-carbidopa intestinal gel treatments versus participants continuing on oral therapy for Parkinson's Disease.

First Posted: 2015-03-06

Condition(s): Parkinson's Disease (PD)

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 136

Allocation:

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2020-01-07

CT.gov Identifier: NCT02381444

Vigor and the LDR in Parkinson Disease

Parkinson disease (PD) is a common disorder in which reduced speed of movement results from inadequate brain production of the chemical dopamine. The most effective treatment for PD is the drug levo-dopa, which partially replaces brain dopamine. Despite decades of successful use, how levo-dopa improves speed of movement in PD is not understood. This observational study recruits participants who have been prescribed levo-dopa by their treating physicians. Before their first dose, immediately after their first dose and later, when their dose has been stabilized, they will engage with the research team to participate in a few simple experiments to measure speed, grip strength, tremor, and stability (on and off of treatment). The purpose of these experiments is to understand how levo-dopa treatment in Parkinson disease enhances movement speed. An important but not understood component of levo-dopa action, the Long Duration Response (LDR), lasts for days to weeks. A basic function of dopamine signaling in the brain is modulation of motivation - the coupling between effort and action values. These experiments will determine if the LDR is associated with relative normalization of motivation function in the brain. The motivation behavior of recently diagnosed PD participants will be examined before and after treatment with levo-dopa to determine if the magnitude of the LDR is correlated with improvements in motivation behavior.

First Posted: 2021-03-30

Condition(s): Parkinson Disease

Intervention(s): carbidopa/levodopa, as prescribed by treating physician

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation: NON_RANDOMIZED

Sponsor: University of Michigan

Principal Investigator: Roger L. Albin, Professor of Neurology

Completion Date (primary or actual): 2024-04-25

CT.gov Identifier: NCT04821830

Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies

OBJECTIVES: I. Provide curative immunoreconstituting allogeneic bone marrow transplantation for patients with primary immunodeficiencies. II. Determine relevant outcomes of this treatment in these patients including quality of survival, extent of morbidity and mortality from complications of the treatment (e.g., graft versus host disease, regimen related toxicities, B- cell lymphoproliferative disease), and completeness of functional immunoreconstitution.

First Posted: 2000-07-06

Condition(s): Immunologic Deficiency Syndromes, Chediak-Higashi Syndrome, Common Variable Immunodeficiency, Graft Versus Host Disease, X-Linked Lymphoproliferative Syndrome, Familial Erythrophagocytic Lymphohistiocytosis, Hemophagocytic Lymphohistiocytosis, X-linked Agammaglobulinemia, Wiskott-Aldrich Syndrome, Chronic Granulomatous Disease, X-linked Hyper IgM Syndrome, Severe Combined Immunodeficiency, Leukocyte Adhesion Deficiency Syndrome, Virus-Associated Hemophagocytic Syndrome

Intervention(s): anti-thymocyte globulin, busulfan, cyclophosphamide, cyclosporine, etoposide, methotrexate, methylprednisolone, prednisone, Allogeneic Bone Marrow Transplantation

Status: TERMINATED

Enrollment (expected or actual):

Allocation:

Sponsor: Fairview University Medical Center

Principal Investigator:

Completion Date (primary or actual): 2002-12

CT.gov Identifier: NCT00006054

Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone

The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG and then assessing their responses to THC.

First Posted: 2015-10-15

Condition(s): Healthy

Intervention(s): Active Delta-9-THC, Active Pregnenolone, Placebo, Placebo

Status: COMPLETED

Enrollment (expected or actual): 38

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Professor of Psychiatry

Completion Date (primary or actual): 2019-06-24

CT.gov Identifier: NCT02576912

PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product

This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.

First Posted: 2019-06-13

Condition(s): Chronic Pain

Intervention(s): Cannabidiol, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 25

Allocation: NON_RANDOMIZED

Sponsor: Staci Gruber, Ph.D.

Principal Investigator: Staci Gruber, Ph.D., Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core; Associate Professor of Psychiatry, Harvard Medical School

Completion Date (primary or actual): 2026-11

CT.gov Identifier: NCT03984565

Cannabidiol (CBD) and Pediatric Epilepsy

Legislation to allow medical marijuana has had a significant impact on the pediatric population of Colorado. There have been many reported different effects and properties of each of the over 60 known cannabinoids found in marijuana. The main exposures in pediatrics have involved the use of Cannabidiol (CBD) high- and Tetrahydrocannibinol (THC) low-content hash oil in children with epilepsy. The reported benefit of this oil is to have the anticonvulsant properties of CBD without the psychoactive components of THC. Human studies on the efficacy of CBD on epilepsy are few and limited. The investigators' specific aims are the following: * Specific Aim 1: Describe the plasma pharmacokinetics of Cannabidiol (CBD), Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with epilepsy. * Specific Aim 2: Describe the plasma pharmacokinetics of other antiepileptic drugs (AEDs) taken in conjunction with CBD in order to evaluate drug interactions. * Specific Aim 3: Describe parental perception of efficacy of CBD on control of epilepsy. The investigators will recruit children and their parents who are currently using or plan to use CBD for their seizure disorder. This study will NOT be providing patients with CBD. Consenting subjects will undergo a number of blood and urine collection that will be analyzed to describe the pharmacokinetics and possible drug interactions of CBD in pediatric epilepsy.

First Posted: 2015-05-18

Condition(s): Epilepsy

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 42

Allocation:

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2018-09-11

CT.gov Identifier: NCT02447198

Evaluation of Menses in Congenital Bleeding Disorders

Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have been proposed to define this symptom: 60 on each cycle has also been confirmed in our preliminary study on 87 healthy women. The quantitative determination of menstrual blood losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a quite frequent symptom in healthy women apparently haemostatically competent in the fertile age (20-30%), its incidence becomes very high in women affected by congenital coagulation factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom "menorrhagia" has an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported. This explains the need for a study focused on the evaluation of menorrhagia in CBDs, addressed to answer to the following, still unsolved questions: 1. Definition of the entity of menstrual blood losses in women affected by CBDs 2. Elaboration of specific treatment schedules for each type of CBD 3. Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).

First Posted: 2010-12-17

Condition(s): Von Willebrand Disease, Congenital Coagulation Factors Deficiency, Haemophilia Carriers

Intervention(s):

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation:

Sponsor: University of L'Aquila

Principal Investigator:

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT01261936

A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients

This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.

First Posted: 2015-05-20

Condition(s): Parkinson's Disease

Intervention(s): TRIGEL, Duodopa

Status: COMPLETED

Enrollment (expected or actual): 11

Allocation: RANDOMIZED

Sponsor: LobSor Pharmaceuticals AB

Principal Investigator:

Completion Date (primary or actual): 2015-07

CT.gov Identifier: NCT02448914

Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients

This is an open-label, postmarketing, observational study to document health outcomes, in Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa (levodopa/carbidopa intestinal gel).

First Posted: 2015-06-30

Condition(s): Parkinson Disease (PD)

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 88

Allocation:

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2020-02-26

CT.gov Identifier: NCT02485600

Maternal Marijuana Use and Fetal and Infant Outcome

Marijuana and cannabis-containing products are growing in popularity and availability in the United States, and use during pregnancy has increased dramatically. The overarching aim of this proposal is to provide pilot data for a submission which will explore the impact of chronic maternal marijuana use (primary or secondary) on fetal functioning, maternal reflective functioning and infant birth and neurodevelopmental outcomes. Chronically marijuana using pregnant women in treatment at the Center for Addiction and Pregnancy will be enrolled and asked to provide information about participants' marijuana and other licit and illicit substance use and feelings about parenting and participants' infant and undergo fetal monitoring at 36 weeks gestation. The neonates will undergo neurobehavioral examination during the first and fourth weeks of life.

First Posted: 2020-02-12

Condition(s): Cannabis Use Disorder, Pregnancy Related

Intervention(s): Maternal-fetal monitoring, NICU Network Neurobehavioral Scale

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation:

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2021-02-15

CT.gov Identifier: NCT04266314

Investigating the Acute Effects of THC on Functional Brain Systems

The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.

First Posted: 2008-03-05

Condition(s): Reward, Tetrahydrocannabinol, Endocannabinoids, Memory, Magnetic Resonance Imaging

Intervention(s): Delta9-tetrahydrocannabinol (THC)

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: UMC Utrecht

Principal Investigator:

Completion Date (primary or actual): 2008-09

CT.gov Identifier: NCT00628706

Double-Blind Randomized Placebo-Controlled Trial of a Proprietary Full Hemp Flower Formulation for Long COVID

This is a double-blind, randomized, placebo-controlled single-center clinical trial to explore the safety and efficacy of a full cannabis flower formulation, rich in cannabinoids and terpenes formulation, Xltran Plus™ and Xltran™, both compared to placebo for the treatment of Long COVID patients with prolonged symptoms caused by COVID-19.

First Posted: 2022-07-21

Condition(s): Post-acute COVID-19 Syndrome

Intervention(s): Xltranplus, Xltran

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: LUCINDA BATEMAN, MD

Principal Investigator: LUCINDA BATEMAN, MD, Medical Director

Completion Date (primary or actual): 2025-12

CT.gov Identifier: NCT05467904

PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

The overarching goal of this double-blind, placebo-controlled, crossover study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) effects of the main analgesic and psychoactive constituent of cannabis, delta-9 tetrahydrocannabinol (THC), among older adults - the fastest growing population of cannabis consumers, and the most likely age cohort to use cannabinoids to relieve pain. This protocol includes two sub-studies, each randomizing 20 men and women aged 65 years or older to receive two administration routes of THC; oral administration and vaporized administration.

First Posted: 2023-06-18

Condition(s): Pain, Tolerance, Oral vs Vaporized THC, Abuse Liability

Intervention(s): Dronabinol 5 MG, Dronabinol 10 MG, 2mg Purified THC in an ethanolic solution, 4mg Purified THC in an ethanolic solution, Placebo

Status: RECRUITING

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Joao De Aquino, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2026-08-31

CT.gov Identifier: NCT05906511

MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facility in Geneva

The behavioral and psychological symptoms of dementia affect up to 80% of long-term facilities residents with severe dementia. They seriously alter the quality of life of patients, relatives, and health professionals. Management involves correcting somatic and psychiatric factors and implementing non-drug interventions. Nevertheless, often drug treatments must be introduced with the limitations related to their effectiveness and adverse effects. The investigators hypothesize that medical cannabinoids will improve neuropsychiatric and behavioral symptoms of patients with severe dementia. The investigators assessed the feasibility and safety of administering a cannabis oil that contains tetrahydrocannabinol (THC) and Cannabidiol (CBD) during an initial study of about two years, observing an overall improvement, excellent tolerance to the treatment, and the possibility of reducing or even stopping other drugs. This research project aims to study the efficacy of medical cannabis oil in improving the quality of life of dementia patients experimenting with behavioral and psychological symptoms.

First Posted: 2022-06-27

Condition(s): Dementia with Behavioral Disturbance

Intervention(s): Cannabis Sativa Oil, Placebo

Status: COMPLETED

Enrollment (expected or actual): 27

Allocation: RANDOMIZED

Sponsor: Fondation pour l'accueil et l'hébérement des personnes âgées

Principal Investigator:

Completion Date (primary or actual): 2024-11-29

CT.gov Identifier: NCT05432206

Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders

This study is being done to see if icariin will help with depression in patients with bipolar disorder and alcohol or cocaine use disorders. The pills used in this study contain 20% icariin.

First Posted: 2013-11-08

Condition(s): Bipolar Disorder, Substance Use Disorder

Intervention(s): Icariin

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: University of Texas Southwestern Medical Center

Principal Investigator: Sherwood Brown, E. Sherwood Brown, M.D., Ph.D., Professor

Completion Date (primary or actual): 2015-06

CT.gov Identifier: NCT01979133

Effects of THC and Alcohol on Driving Performance

Low blood concentrations of THC and alcohol appear to have a minimal effect on driving performance.However, there is a gap in the literature about the combined effects of THC and alcohol. There is little empirical evidence to determine whether the combination of THC and alcohol could be additive or multiplicative. This issue is particularly important when dealing with concentrations that are just below legal thresholds - it is important to identify if someone who may have consumed cannabis and alcohol, in quantities that do not exceed legal thresholds, may nonetheless be impaired to drive. Answering this question requires more research on the combined effects of THC and alcohol under tightly controlled experimental conditions. Hence, the purpose of this study is to determine the additive (or multiplicative) effect of standardized low doses of cannabis, in combination with low-doses of alcohol, on a number of outcome measures related to driving. The investigators will focus specifically on the effect of low blood concentrations of THC (0, 125, and 250 µg/kg) alone and in combination with low blood concentrations of alcohol (BAC 0%, .025%, and .049%). They shall determine the combined effect of THC and alcohol on physiological, cognitive, subjective measures of impairment, and simulated driving. This study will focus on younger adults because they have higher impaired driving rates than other age groups. As a secondary aim of the study, the investigators will examine whether previous driving and drug use history are correlated with driving decisions during the simulated drive and subjective measures. This study will contribute to the evidence base informing legislation, policy making, and law enforcement. This study is particularly timely given upcoming changes in legislation about cannabis, and because the combination of THC and alcohol, even below legal thresholds, may lead to impaired driving and crashes.

First Posted: 2018-06-14

Condition(s): Cannabis, Alcohol Drinking, Accident, Traffic

Intervention(s): THC 0, THC 5, THC 10, BAC 0, BAC .025, BAC .049

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Lakehead University

Principal Investigator:

Completion Date (primary or actual): 2021-12

CT.gov Identifier: NCT03555968

A Bioavailability Study on Dronabinol

This study is a two part study

First Posted: 2017-04-04

Condition(s): THC

Intervention(s): Chewing Gum

Status: UNKNOWN

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Axim Biotechnologies

Principal Investigator:

Completion Date (primary or actual): 2018-09

CT.gov Identifier: NCT03098940

Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

This 2-arm study will recruit participants with 1) alcohol use disorder and 2) cannabis use disorder for a 12-week cognitive behavioral therapy, following a thorough baseline assessments on executive function, incentive salience, and negative emotionality.

First Posted: 2023-05-11

Condition(s): Alcohol Use Disorder, Cannabis Use Disorder

Intervention(s): CBT

Status: RECRUITING

Enrollment (expected or actual): 400

Allocation: NON_RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2027-12

CT.gov Identifier: NCT05855668

Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis

As medical cannabis use becomes more common in the United States, it is essential to understand the ways in which adults who use medical cannabis perceive the benefits of cannabis use and to identify effective strategies to help them cope with these problems. Emerging data indicate that insomnia and/or use of cannabis for sleep are very common in medical cannabis patients. The present study will adapt and gather pilot data on the impact of a Cognitive Behavioral Therapy for insomnia (CBTi-CB) intervention on sleep- and cannabis-related outcomes in adults who use medical cannabis.

First Posted: 2019-05-28

Condition(s): Insomnia Chronic, Cannabis Use

Intervention(s): Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB), Sleep Hygiene Education (SHE)

Status: COMPLETED

Enrollment (expected or actual): 57

Allocation: RANDOMIZED

Sponsor: University of Michigan

Principal Investigator: Mark A. Ilgen, Associate Professor of Psychiatry

Completion Date (primary or actual): 2021-07-13

CT.gov Identifier: NCT03964974

PET Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2

The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders.

First Posted: 2008-01-21

Condition(s): CB1, Cannabinoid, PET, Brain Imaging

Intervention(s): [18F]FMPEP-d2

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: NON_RANDOMIZED

Sponsor: National Institute of Mental Health (NIMH)

Principal Investigator:

Completion Date (primary or actual): 2009-10

CT.gov Identifier: NCT00598286

Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)

The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.

First Posted: 2018-10-29

Condition(s): Smoking

Intervention(s): smokeSCREEN video game

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation: NA

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): 2018-09-28

CT.gov Identifier: NCT03722888

Investigation of Cannabis for Pain and Inflammation in Lung Cancer

Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. It can also result in stopping or delaying treatment.Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. The endocannabinoid system is prominent in the gastrointestinal system, and cannabis has been shown to greatly inhibit inflammation. The compound (-)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation and pain. Cannabidiol is a component of cannabis that does not produce subjective or intoxicating effects, but also has prominent anti-inflammatory properties. The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used , which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.

First Posted: 2016-02-05

Condition(s): Lung Cancer

Intervention(s): Smoked Cannabis High CBD/low THC, Smoked Placebo Cannabis Low CBD/low THC

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Diana Martinez, Associate Professor of Psychiatry at CUMC

Completion Date (primary or actual): 2021-10-28

CT.gov Identifier: NCT02675842

Fibres Supplementation in Rheumatoid Arthritis

Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with either fiber supplements or placebo. Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes : variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and B cells, Th17) and heart-rate variability. Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate disease activity will be recruited in each arm and 29 controls with mechanic disease (osteoarthritis, tendinitis). Collection: Blood, feces, disease activity and heart rate variability will be collected at baseline and week 4.

First Posted: 2020-06-09

Condition(s): Rheumatoid Arthritis

Intervention(s): Dietary Fiber Supplementation

Status: UNKNOWN

Enrollment (expected or actual): 87

Allocation: RANDOMIZED

Sponsor: University Hospital, Montpellier

Principal Investigator:

Completion Date (primary or actual): 2024-10

CT.gov Identifier: NCT04421313

Real-world Evidence of Cannabinoid for Observed Pain Relief

Chronic muscle pain is one of the most prevalent clinical challenges in sports medicine, significantly affecting training capacity, competitive performance, and quality of life in athletes. The endocannabinoid system has emerged as a promising therapeutic target for pain modulation in the sports context. This prospective, comparative, non-randomized observational study aims to evaluate whether adjuvant topical application of a cannabinoid balm (CBD:THC 3:1 - Papa \& Barkley) provides additional reduction in chronic muscle pain intensity in athletes, compared to systemic CBD oil alone, over 90 days of follow-up in a real-world clinical practice setting. Sixty adult athletes (amateur or professional) with established chronic muscle pain (≥3 months) who receive clinical indication for cannabinoid therapy will be followed in two observational cohorts: Cohort A (n=30), receiving only systemic CBD oil (60 mg/day oral/sublingual), and Cohort B, (n=30) receiving systemic CBD oil plus the topical cannabinoid balm (CBD:THC 3:1, applied twice daily to the affected muscle area). Treatment allocation is based exclusively on the clinical decision of the principal investigator, reflecting routine medical practice. The primary outcome is the change in Brief Pain Inventory (BPI) scores from baseline (D0) to end of follow-up (D90). Secondary outcomes include pain intensity (NRS), sleep quality (PSQI), quality of life (SF-36), perceived muscle recovery (TQR scale), functional capacity (LEFS/UEFI), rescue analgesic use, and safety/tolerability of the topical formulation. The study aims to generate real-world evidence on the effectiveness and safety of adjuvant topical cannabinoid therapy in athletes with chronic muscle pain in the Brazilian clinical practice setting.

First Posted: 2026-07-29

Condition(s): Chronic Musculoskeletal Pain, Delayed Onset Muscle Soreness (DOMS)

Intervention(s):

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 60

Allocation:

Sponsor: Associação Pan-Americana Multidisciplinar de Endocanabinologia

Principal Investigator:

Completion Date (primary or actual): 2027-07-01

CT.gov Identifier: NCT07733791

Impact of Cannabis Use and Abstinence on Emotion

The goal of this experimental study is to test how three weeks of cannabis abstinence impacts threat and reward processing in females with Cannabis Use Disorder. The main questions it aims to answer are: Compared to using cannabis as usual, will cannabis cue reactivity increase throughout three weeks of abstinence from cannabis? Compared to using cannabis as usual, will threat reactivity be elevated at weeks 1 and 2 of abstinence followed by a decrease at week 3 of abstinence? Compared to using cannabis as usual, will non-drug reward reactivity be lower at weeks 1 and 2 of abstinence followed by an increase at week 3 of abstinence? Compared to successful 3-week abstainers, will threat, non-drug reward, and cannabis cue reactivity differ in relapsers? Researchers will compare females with CUD who abstain from cannabis for three weeks to those who continue to use cannabis as usual to see how cannabis abstinence impacts threat and reward processing. Participants will: Be randomly assigned to continue using cannabis as usual or abstain from cannabis for three weeks Visit the lab 6 times over three weeks, followed by a 1-month follow-up lab visit for the participants assigned to the cannabis abstinence condition Complete phone surveys every other day across the three week study period

First Posted: 2026-08-05

Condition(s): Cannabis Use Disorder, Severe

Intervention(s): Contingency management for cannabis abstinence and lab visit attendance, Contingency management for lab visit attendance

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Florida State University

Principal Investigator: Rick James Macatee, Principal Investigator

Completion Date (primary or actual): 2024-07-15

CT.gov Identifier: NCT07746440

Topical CBD for Musculoskeletal Pain

Various OTC and CBD containing topicals are evaluated in a double blind survey. Each sample has a QR code that is to be scanned before applying. The QR code links to a survey form with application instructions and collects participant information and feedback.

First Posted: 2022-06-09

Condition(s): Pain

Intervention(s): GoodFOR Pain, Icy Hot, Tiger Balm, Bengay, CBD Clinic Muscle and Joint Pain Relief Ointment, CBD FX CBD Muscle and Joint Cream: Cooling Formula, Essential Wholesale Muscle Gel, Extract Labs Muscle Cream

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Apothyx, Co.

Principal Investigator: Daniel Charles McShan, PhD, Chief Scientist

Completion Date (primary or actual): 2022-11-25

CT.gov Identifier: NCT05411913

Medical Cannabis Against Chronic Musculoskeletal Pain: a Mixed Methods Study.

Despite many pharmaceutical options, there are no optimal treatments for Chronic musculoskeletal pain (CMP). Although many Canadians use medical cannabis (MC; legally authorized) to relieve their pain, there are no firm conclusions on the efficacy and safety of MC against CMP. In order to increase knowledge on this topic, it is essential to describe the current use of MC against CMP by Canadians and to understand patients' and physicians' perceptions and attitudes. Objectives: This study will evaluate the use of MC against CMP among adults and aims at: 1-Describing the use of MC in Canada, and the main characteristics of users and prescribers; 2-Identifying the therapeutic and adverse effects of MC from the users' perspective; 3a- Identifying the psychosocial, organizational, socio-demographic and health-related factors that influence the use and prescription of MC; and 3b- Quantifying the impacts of these factors on the use and prescription of MC in the management of CMP. Methods: 1) We will analyse available data on the users and prescribers of MC from Health Canada and from the Registre Cannabis Québec; 2) We will use mixed methods to collect data from patients affected by CMP and their physicians. Data from Health Canada will allow to document the prevalence and recent evolution of MC use. The qualitative phase of the second part of the study will identify obstacles and facilitators for the use AND for the prescribing of MC against CMP, including the need for more information in patients suffering from CMP and in physicians. Reasoned samples of patients and physicians will be recruited; information will then be collected by semi-structured interviews. For the quantitative phase, a pan-Canadian survey will be conducted, using a questionnaire built with the results of the qualitative phase of the study. The proposed study will describe the current use of MC against CMP in Canada and will allow to better understand the motivations and expectations of physicians and patients.

First Posted: 2022-01-27

Condition(s): Musculoskeletal Pain, Cannabis Use

Intervention(s):

Status: UNKNOWN

Enrollment (expected or actual): 45

Allocation:

Sponsor: CHU de Quebec-Universite Laval

Principal Investigator: Dre Edeltraut Kröger, Research Scientist, Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale

Completion Date (primary or actual): 2022-07-31

CT.gov Identifier: NCT05210660

Lorcaserin for Cannabis Use Disorder

The primary purpose of this study is to investigate the effect of lorcaserin on reductions in cannabis use and multiple constructs of impulsivity in outpatient treatment-seeking individuals with cannabis use disorder (CUD). Additionally, the investigators will make use of the technological application of ecological momentary assessments (EMA), to collect real-time data at key time intervals during the study on participants' use of cannabis and other substances in addition to measuring impulsive traits through self-initiated, fixed and random phone prompts. This will be a 13-week randomized, double-blind, placebo-controlled trial, with week 1 focused on baseline assessments of impulsivity (through EMA in vivo and at study visits), weeks 2- 3 of medication lead-in, and week 4 targeting a reduced cannabis use/quit day through week 13. The primary aims are to (1) Examine the effect of lorcaserin compared to placebo, on reductions in cannabis use among treatment-seeking outpatients with CUD, (2) Examine the effect of lorcaserin compared to placebo on behavioral and self-report measures of impulsivity among individuals with CUD during the medication lead-in phase (weeks 2-3). The secondary aim is to examine whether reductions in impulsivity (during weeks 2-3) mediates the effect of lorcaserin on cannabis use (during weeks 8-13), if the primary hypotheses are supported. Finally, the investigators will explore the effect of lorcaserin compared to placebo on (1) drop-out rates, (2) time to discontinuation from study, (3) treatment adherence, and (4) nicotine use.

First Posted: 2018-08-20

Condition(s): Cannabis Use Disorder

Intervention(s): Lorcaserin, Placebo oral capsule

Status: TERMINATED

Enrollment (expected or actual): 5

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Christina Ann Brezing, Clinical Psychiatrist

Completion Date (primary or actual): 2020-02-29

CT.gov Identifier: NCT03637842

Development and Evaluation of HighAlert

In Canada, youth ages 16-24 have the highest rates of cannabis use, impaired driving, and express the least concern for driving under the influence of cannabis (DUIC). As such, developing effective and practical DUIC prevention efforts is crucial. This study aims to evaluate the effects of 'High Alert' in reducing 3-month risky cannabis use and DUIC among young Ontarian drivers. 'High Alert' is an interactive web-based smartphone application developed by the research team with the feedback of experts and youth. 'High Alert' modules focus on recognizing what constitutes risky cannabis use, the effects of cannabis on driving, the risks of DUIC, and strategies to avoid DUIC. A pilot randomized controlled trial will compare the effects of 'High Alert' with an active control (DUIC Information) and passive control (no contact). Overall, effectively preventing DUIC among youth is critically needed and time-sensitive.

First Posted: 2023-10-24

Condition(s): Cannabis, Youth Drinking

Intervention(s): High Alert, Information condition, No contact

Status: COMPLETED

Enrollment (expected or actual): 103

Allocation: RANDOMIZED

Sponsor: Western University, Canada

Principal Investigator:

Completion Date (primary or actual): 2024-09-10

CT.gov Identifier: NCT06098573

Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal

Cannabis dependence is associated with changes in the brain's cannabinoid system. When cannabis dependent individuals try to quit using cannabis, some of them experience problems that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the problems related to quitting cannabis may facilitate abstinence. One way to do this is by harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids. One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the problems related to quitting cannabis use will be reduced by increasing the brain levels of anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will be less likely to relapse. Brain anandamide levels will be increased by blocking the breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis use and urinary THC-COOH levels will be measured during the entire study. The treatment phase will be followed by a safety follow up phase of 8 weeks.

First Posted: 2012-06-13

Condition(s): Cannabis Dependence

Intervention(s): PF-04457845, Placebo

Status: COMPLETED

Enrollment (expected or actual): 70

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Associate Professor of Psychiatry

Completion Date (primary or actual): 2016-03-11

CT.gov Identifier: NCT01618656

Palmitoylethanolamide in Ulcerative Colitis

Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.

First Posted: 2026-05-27

Condition(s): Ulcerative Colitis (UC)

Intervention(s): Palmitoylethanolamide (PEA), Placebo

Status: RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Ain Shams University

Principal Investigator: Ahmed Emad, Teaching assistant in Clinical Pharmacy Department

Completion Date (primary or actual): 2029-02-15

CT.gov Identifier: NCT07609810

Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee

The purpose of the study is to evaluate the efficacy of PG-OA-10CN and PG-OA-5TH tablets as a better pain reliever in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo.

First Posted: 2021-08-06

Condition(s): Osteoarthritis, Knee

Intervention(s): CBD/CBN, CBD/THC, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 66

Allocation: RANDOMIZED

Sponsor: Pure Green

Principal Investigator:

Completion Date (primary or actual): 2021-11-14

CT.gov Identifier: NCT04992962

CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms

The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients infected with SARS-CoV-2. The specific objectives are to assess whether, in patients with mild and moderate forms of SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of: i) decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv) improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor the possible adverse effects of CBD use in these patients.

First Posted: 2020-07-13

Condition(s): SARS-CoV2

Intervention(s): Cannabidiol, PLACEBO

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: University of Sao Paulo

Principal Investigator: Jose Alexandre de Souza Crippa, Professor of Psychiatry, MD, PhD

Completion Date (primary or actual): 2021-11-16

CT.gov Identifier: NCT04467918

This Research Study Examines the Effects of Cannabidiol-infused Candy on Reducing the Bacteria Causing Tooth Decay, When Comparing it to a Sugar Free Candy on Adults.

The goal of this clinical trial is to compare the effect of CBD candy versus sugar free candy on reducing the number of bacteria causing tooth decay, in adults The main question is to see whether CBD have any effect on reducing the number of Streptococcus mutans, in the oral cavity the main bacteria causing tooth decay. Participants will be randomly placed in a group, and assigned to take either CBD-infused lozenge (if in the experimental group) or a sugar-free candy (if in the control group) once a day for 15 days. A sample of saliva will be collected and analyzed in a lab before and after consumption of the candy to see whether either product could reduce the harmful bacteria in the mouth.

First Posted: 2024-03-08

Condition(s): Tooth Decay

Intervention(s): CBD infused candy, Sugar free Candy

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: West Coast University

Principal Investigator: Jila Torabi, Assistant Professor

Completion Date (primary or actual): 2023-02-11

CT.gov Identifier: NCT06301113

Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg Vs Placebo As Adjuvant Treatment in Chronic Migraine -

To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, atenolol, topiramate, valproic acid/sodium valproate, levetiracetam, gabapentin, lamotrigine, pre-gabaline, flunarizine, amitriptyline, nortriptyline, clomipramine, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases\> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment or that changed the preventive treatment less than 3 months from the study start, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort, clobazam, macrolides, verapamil, fluoxetine, amiodarone and tacrolimus. Patients on vitamin K anticoagulant medicines, as warfarin. Randomization using a computacional system will stratify participants in each group by gender (F/M), age (25-34/35-44/45-54/55-65yo), headache days presented in the baseline month (5-10/11-15/16-20/21-25/26-30), overuse medication (yes or no). After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum daily dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit). The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample. Clinical data will be registered on a personalized headache diary developed to this study using MyCap, from RedCap System, as an APP for daily entries using smartphones, androids or IOS system. The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary endpoints, the proposal of which is to publish the data regardless of the results obtained.

First Posted: 2021-08-04

Condition(s): Chronic Migraine, Headache, Overuse Headache Medication

Intervention(s): Placebo oral drops, Cannabidiol + Cannabigerol + Tetrahydrocannabinol 133/66/4mg

Status: TERMINATED

Enrollment (expected or actual): 110

Allocation: RANDOMIZED

Sponsor: Hospital Israelita Albert Einstein

Principal Investigator: Alexandre Kaup, Principal Investigator, MD

Completion Date (primary or actual): 2025-02-20

CT.gov Identifier: NCT04989413

Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana \[Delta-9-tetrahydracannabinol (THC)\] with NLX as a proof of concept towards the possible development of a combined overdose reversal agent with improved tolerability.

First Posted: 2021-11-10

Condition(s): Opioid Overdose

Intervention(s): Naloxone, Marijuana

Status: TERMINATED

Enrollment (expected or actual): 2

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Jermaine D. Jones, Principal Investigator

Completion Date (primary or actual): 2024-10-29

CT.gov Identifier: NCT05114460

Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation

In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum effective dose required for reliable engraftment for subjects undergoing hematopoietic stem cell transplantation for non-malignant disease.

First Posted: 2018-05-01

Condition(s): Bone Marrow Failure Syndrome, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia, Acquired Neutropenia in Newborn, Acquired Anemia Hemolytic, Acquired Thrombocytopenia, Hemophagocytic Lymphohistiocytoses, Wiskott-Aldrich Syndrome, Chronic Granulomatous Disease, Common Variable Immunodeficiency, X-linked Lymphoproliferative Disease, Severe Combined Immunodeficiency, Hurler Syndrome, Mannosidosis, Adrenoleukodystrophy

Intervention(s): Thiotepa--single daily dose, Thiotepa--escalated dose

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: RANDOMIZED

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): 2023-02-19

CT.gov Identifier: NCT03513328

CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)

Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation. Double-blind treatment will be initiated 10 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks. The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.

First Posted: 2024-11-27

Condition(s): Recurrent Pericarditis

Intervention(s): CardiolRx

Status: RECRUITING

Enrollment (expected or actual): 110

Allocation: RANDOMIZED

Sponsor: Cardiol Therapeutics Inc.

Principal Investigator:

Completion Date (primary or actual): 2026-10-21

CT.gov Identifier: NCT06708299

Survey on the Place of Community Pharmacists in the Detection of Cannabis Use: a Student's Point of View

The objective of this survey will be to evaluate the perception by the students (except for medical students, pharmacies) of community pharmacists concerning the management of cannabis consumption. We want to see if the student population perceives the pharmacist as the public health actor of choice, and if they would more easily turn to him or to another health professional (doctor, nurse) in case they need. Discussing possible problematic consumption or for a simple search for information. It will be assessed whether the pharmacist seems to be a good candidate and an element of choice when young adults want to take an intelligence approach to cannabis consumption.

First Posted: 2017-05-25

Condition(s): Cannabis Use

Intervention(s): Survey

Status: COMPLETED

Enrollment (expected or actual): 150

Allocation:

Sponsor: University Hospital, Clermont-Ferrand

Principal Investigator:

Completion Date (primary or actual): 2017-06-02

CT.gov Identifier: NCT03167021

Cannabis Oil for Chronic Non-Cancer Pain Treatment

Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. The cannabis plant (Cannabis sativa, Cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. The two active cannabinoids of interest in this trial are tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). The goal of this trial is to determine whether CBD or CBD+THC reduces the average pain in participants with chronic non-cancer pain. The investigators also aim to determine whether CBD or CBD+THC is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.

First Posted: 2018-08-17

Condition(s): Chronic Non-cancer Pain

Intervention(s): CBD, CBD+THC, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 309

Allocation: RANDOMIZED

Sponsor: Hamilton Health Sciences Corporation

Principal Investigator: Ramesh Zacharias, Medical Director

Completion Date (primary or actual): 2021-01-30

CT.gov Identifier: NCT03635593

High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer

This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Women on AI therapy may experience joint stiffness, pain and arthritis symptoms as a side effect of the medication. Some women stop AI therapy due to these side effects and do not receive the maximum benefit from the medication. CBD is derived from the same plant family as marijuana but is not associated with a "high" or mind-altering effect and is not habit-forming. Research in animals and humans indicates that CBD might decrease inflammation in joint tissues and may help reduce chronic pain in ailments such as arthritis. BRC-001 may reduce joint pain in women with breast cancer taking AIs.

First Posted: 2024-08-05

Condition(s): Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Breast Adenocarcinoma, Breast Ductal Carcinoma In Situ, Estrogen Receptor-Positive Breast Carcinoma, Progesterone Receptor-Positive Breast Carcinoma

Intervention(s): Biospecimen Collection, BRC-001, Placebo Administration, Questionnaire Administration

Status: SUSPENDED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: City of Hope Medical Center

Principal Investigator:

Completion Date (primary or actual): 2027-01-24

CT.gov Identifier: NCT06538389

Skills and Motivation at the Rhode Island Training School (Project SMART) - 1

This study will focus on treating substance abusing incarcerated teens using individually administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy (CBT). The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Currently, there is little research regarding effective group treatments for incarcerated teens and this study will address this gap in our knowledge base. We seek to reduce substance use and associated risky behaviors post-release (including driving under the influence, risky sexual behaviors, etc.).

First Posted: 2005-09-28

Condition(s): Alcoholic, Marijuana Misuse

Intervention(s): MI/CBT, RT/TU

Status: COMPLETED

Enrollment (expected or actual): 205

Allocation: RANDOMIZED

Sponsor: University of Rhode Island

Principal Investigator: Lynda Stein, Ph.D., Professor

Completion Date (primary or actual): 2011-09

CT.gov Identifier: NCT00227890

Marijuana for HIV-Related Peripheral Neuropathy

To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.

First Posted: 2002-10-03

Condition(s): Peripheral Nervous System Diseases, HIV Infections

Intervention(s): Smoked Marijuana

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Center for Medicinal Cannabis Research

Principal Investigator:

Completion Date (primary or actual): 2005-04

CT.gov Identifier: NCT00046722

Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

The goal of this clinical trial will be to evaluate the effect applying an experimental gel based on cannabidiol oil (CBD) on tooth sensitivity induced by tooth bleaching with 35% hydrogen peroxide (HP). Volunteers will be selected and allocated to the following groups: GP - placebo gel, GCBD - experimental cannabidiol gel and GKF - Potassium Nitrate and Sodium Fluoride Gel. In each group, the corresponding desensitizing gel will be applied to on the teeth for 10 minutes. All groups will then undergo in-office whitening treatment with 35% hydrogen peroxide. Patients will be instructed to record tooth sensitivity on a daily basis during the 21 days of follow-up. Pain intensity will be measured using a visual analog scale (VAS), while the risk of developing sensitivity will be recorded after each session of the whitening procedure, with two response option.

First Posted: 2025-06-18

Condition(s): Dentin Sensitivity

Intervention(s): Potassium nitrate and sodium fluoride, Cannabidiol (CBD) Gel, Natrosol 4% Gel

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 75

Allocation: RANDOMIZED

Sponsor: Universidade Federal do Para

Principal Investigator: Jesuína Lamartine Nogueira Araújo, Principal Investigator: Clinical Professor

Completion Date (primary or actual): 2026-07

CT.gov Identifier: NCT07027566

Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages

Aneurysmal subarachnoid hemorrhage (aSAH) is a dreadful acute neurological condition with overwhelmingly high rate of associated morbidities and mortality. Despite leaping advancement in neurosurgical techniques and imaging modalities, there is no substantiative improvement in overall prognosis for aSAH. Cerebral vasospasm remains the predominant cause of associated morbidities. Human albumin has been used in different neurological conditions including head trauma, intracerebral hemorrhages, and ischemic strokes with favorable outcome. However, its beneficial use in aSAH has not been sufficiently explored until recently a published systematic review by our team. In view of scarcity of published data and lack of robust evidence, our group has designed for the first ever RCT to compare the use human albumin-enhanced fluid management versus standard fluid therapy with crystalloids in patients with aSAH. This single center open label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha-Qatar from August 2024 to July 2027. A sample size of 84 (42 in each arm) has been calculated to detect as sufficient to detect a clinically significant difference in modified Rankin Scale good score between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aneurysmal subarachnoid hemorrhages patients. Primary outcome will be based on dichotomized modified Rankin scale \[(Good grades (0-2) and poor grades (3-6)\], while secondary outcome will include symptomatic vasospasm, transcranial doppler velocities, and Pulse Index Contour Cardiac Output (PiCCO) parameters. The trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve optimal fluid management regime to explore its potential role to improve clinical outcome in patients with aSAH.

First Posted: 2024-08-12

Condition(s): Aneurysmal Subarachnoid Hemorrhage

Intervention(s): Human albumin

Status: RECRUITING

Enrollment (expected or actual): 84

Allocation: RANDOMIZED

Sponsor: Hamad Medical Corporation

Principal Investigator: Dr Arshad Ali, Consultant neurosurgery

Completion Date (primary or actual): 2027-07-31

CT.gov Identifier: NCT06548477

Cannabidiol for Bipolar Depression (CBD-BD)

Bipolar disorder (BD) is a lifelong condition characterized by recurrent episodes of depression and (hypo)mania. Periods of chronic and recurring depressive episodes are more common and can be severely disabling. Effective treatments exist; however, a significant portion of bipolar depressed patients do not respond to or have difficulty tolerating many of these interventions and thus look beyond established treatments to achieve symptom relief. Cannabidiol (CBD), a chemical from the Cannabis sativa plant, has shown to have some beneficial effects on mood symptoms in a few small studies which assessed its effects in other mental and physical health conditions, but no large studies have been conducted to assess its safety and efficacy in bipolar depression. Additionally, several clinical studies have shown CBD to be safe and tolerable. The primary objective of this study is to assess the effectiveness, safety and tolerability of cannabidiol in patients with bipolar depression (BD I or BD II) who have not responded to adequate trials with at least one first-line treatment for bipolar depression in comparison to those who will be treated with placebo. Placebo is an inactive substance that looks identical to the study medication but contains no therapeutic ingredient. This study is a randomized (like the flip of a coin), double-blind (you and the study team will not know which treatment arm you receive) study in which participants will receive either CBD or placebo added to their current treatment. Participants will have 5 clinical appointments and a phone appointment over a period of 10 weeks.

First Posted: 2023-05-22

Condition(s): Bipolar Disorder

Intervention(s): Cannabidiol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 360

Allocation: RANDOMIZED

Sponsor: University of British Columbia

Principal Investigator: Lakshmi N Yatham, Investigator

Completion Date (primary or actual): 2030-12

CT.gov Identifier: NCT05867849

Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis

This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).

First Posted: 2019-12-18

Condition(s): Multiple Sclerosis (MS)

Intervention(s): Nabiximols, Placebo

Status: TERMINATED

Enrollment (expected or actual): 139

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2023-02-28

CT.gov Identifier: NCT04203498

Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off

This study will evaluate the effects of immediate release (IR) carbidopa levodopa versus the effects of immediate-release carbidopa/levodopa on ERP parameters in patients with idiopathic PD.

First Posted: 2008-01-28

Condition(s): Parkinson's Disease

Intervention(s): carbidopa/levodopa, Carbidopa/Levodopa/Entacapone

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Novartis Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2009-11

CT.gov Identifier: NCT00601978

Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.

First Posted: 2017-11-28

Condition(s): Childhood Absence Epilepsy

Intervention(s): Cannabidiol Oral Solution

Status: TERMINATED

Enrollment (expected or actual): 11

Allocation: NA

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): 2019-06-28

CT.gov Identifier: NCT03355300

Participation in a Research Registry for Immune Disorders

Background: \- People with primary immune deficiency diseases (PIDD) have weak immune systems. This makes it hard for their bodies to fight infection. The Immune Deficiency Foundation has a network to collect data about people with PIDD. It is called the United States Immunodeficiency Network. It will help doctors and scientists better understand these disorders. The goal is to get medical data for everyone with these disorders in the U.S. and Canada. Data will be stored in a registry. Researchers can use it to study if these disorders are increasing. They can also learn how the disorders are diagnosed and treated. Objectives: \- To collect data on people with primary immune deficiency disorders. Eligibility: \- People who have a PIDD. Design: * Data can be added with no record of personal identity. * Data can be added with identity kept separate. This data will be linked to the registry by a code number. * Data for the registry includes: * Family history * Disease treatment * Disease characteristics * Medical history * Laboratory data

First Posted: 2013-09-30

Condition(s): Primary Immunodeficiencies, APECED, CGD, Wiskott-Aldrich Syndrome, SCID

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 716

Allocation:

Sponsor: National Human Genome Research Institute (NHGRI)

Principal Investigator:

Completion Date (primary or actual): 2023-07-19

CT.gov Identifier: NCT01953016

Buspirone Treatment for Marijuana Dependence

Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management (CM) intervention and motivational enhancement therapy (MET) will be incorporated to encourage study engagement and retention. It is hypothesized that buspirone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.

First Posted: 2009-04-03

Condition(s): Marijuana Dependence

Intervention(s): Buspirone, Placebo

Status: COMPLETED

Enrollment (expected or actual): 175

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: Aimee McRae-Clark, Professor

Completion Date (primary or actual): 2016-03

CT.gov Identifier: NCT00875836

A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol

The purpose of the study is to evaluate the pharmacodynamic (PD) interaction between steady-steady treatment with padsevonil (PSL) and Ethanol and the pharmacokinetic (PK) interaction between stead-state treatment with PSL and cannabidiol (CBD).

First Posted: 2019-07-31

Condition(s): Healthy Participants

Intervention(s): Padsevonil, Placebo (PSL)

Status: TERMINATED

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: UCB Biopharma S.P.R.L.

Principal Investigator:

Completion Date (primary or actual): 2020-05-22

CT.gov Identifier: NCT04039919

Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis

The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.

First Posted: 2006-12-27

Condition(s): Choledocholithiasis, Cholelithiasis

Intervention(s): Laparoendoscopic Rendez vous, preoperative ERCP and CBD clearance

Status: UNKNOWN

Enrollment (expected or actual): 300

Allocation: RANDOMIZED

Sponsor: University of Thessaly

Principal Investigator:

Completion Date (primary or actual): 2010-12

CT.gov Identifier: NCT00416234

Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation

To identify factors and triggers influencing physical activity (PA) participation after structured cardiac rehabilitation (CR) among older adults who have enrolled in a center-based CR program, and compare the effects of a targeted health coaching intervention versus standard care immediately following structured CR on PA maintenance and functional fitness.

First Posted: 2023-03-17

Condition(s): Cardiac Rehabilitation, Health Coaching, Physical Activity

Intervention(s): Targeted Health Coaching Group, Standard Care Group

Status: COMPLETED

Enrollment (expected or actual): 13

Allocation: RANDOMIZED

Sponsor: Duke University

Principal Investigator:

Completion Date (primary or actual): 2024-06-26

CT.gov Identifier: NCT05773287

Impact of Repeatedly-Administered THC-cannabis on Experimental Pain and Abuse Liability in Humans

Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication, and they report experiencing minimal psychoactive effects. However, there are few well-controlled human laboratory studies assessing cannabis' efficacy for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. Carefully controlled research is needed. The proposed within-subjects, placebo-controlled 16-day crossover inpatient human laboratory study (N = 20 healthy cannabis users; 10 men, 10 women) will address three important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) Does tolerance develop to repeated, daily smoked cannabis administration on measures of experimental pain and abuse liability; 2) If so, is tolerance reversed during the 7 days of abstinence from active-THC cannabis; 3) Does abrupt abstinence from active cannabis increase experimental pain sensitivity, i.e. hyperalgesia, relative to baseline, and do these effects parallel measures of cannabis withdrawal such as disrupted mood and sleep? Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS). Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.

First Posted: 2020-10-22

Condition(s): Cannabis, Pain, Tolerance, Hyperalgesia

Intervention(s): Active Cannabis, Placebo Cannabis

Status: SUSPENDED

Enrollment (expected or actual): 16

Allocation: NON_RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Caroline A. Arout, Ph.D., Assistant Professor of Clinical Neurobiology (in Psychiatry)

Completion Date (primary or actual): 2026-10-31

CT.gov Identifier: NCT04596644

Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

First Posted: 2005-11-15

Condition(s): Parkinson's Disease

Intervention(s): IPX054 200 mg, CD-LD IR, IPX054 Placebo, CD-LD IR Placebo

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): 2007-12

CT.gov Identifier: NCT00253084

Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial

Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.

First Posted: 2022-04-20

Condition(s): Chronic Migraine

Intervention(s): MPL-001

Status: RECRUITING

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: University of Manitoba

Principal Investigator: Lauren Kelly, Lauren E Kelly PhD, MSc, BMedSci, CCRP, Assistant Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, Canadian Childhood Cannabinoid Clinical Trials (www.C4Trials.org)

Completion Date (primary or actual): 2025-12-31

CT.gov Identifier: NCT05337033

HONEY for the Treatment of POst-Tonsillectomy Pain

Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes. Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials.

First Posted: 2024-02-23

Condition(s): Post Surgical Pain, Analgesia

Intervention(s): Manuka honey MGO 1000, Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring

Status: RECRUITING

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: East and North Hertfordshire NHS Trust

Principal Investigator:

Completion Date (primary or actual): 2027-07-31

CT.gov Identifier: NCT06275698

Adaptive Treatment for Adolescent Cannabis Use Disorders

The purpose of this study is to examine an Adaptive Treatment approach in order to improve outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.

First Posted: 2012-08-03

Condition(s): Mental Disorders, Addictive Behaviors, Cannabis Use Disorder

Intervention(s): ACRA, CBT

Status: COMPLETED

Enrollment (expected or actual): 172

Allocation: RANDOMIZED

Sponsor: UConn Health

Principal Investigator:

Completion Date (primary or actual): 2016-07

CT.gov Identifier: NCT01656707

CARS: Cannabis and Alcohol Reduction Study

The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.

First Posted: 2022-08-03

Condition(s): Cannabis Use, Alcohol Use, Unspecified, Substance Use, Substance Use Disorders

Intervention(s): modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias, modified Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.

Status: RECRUITING

Enrollment (expected or actual): 52

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: Austin Hahn, Associate Professor-Faculty

Completion Date (primary or actual): 2026-10-01

CT.gov Identifier: NCT05486234

Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)

A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)

First Posted: 2017-12-29

Condition(s): Cannabis Use Disorder

Intervention(s): PF 04457845, Placebo Oral Tablet

Status: COMPLETED

Enrollment (expected or actual): 228

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Professor of Psychiatry

Completion Date (primary or actual): 2022-07-25

CT.gov Identifier: NCT03386487

The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis

Laboratory change induced by common bile duct (CBD) stone is in general observed as the higher elevation of alkaline phosphatase (ALP) and gamma-glutamyl transpeptideas (ɤ-GT), in comparison to those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). However, some patients with CBD stone show the marked increased level of aminotransferase, which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis, ischemia, and drug toxicity. The aim of this study is to investigate the clinicopathologic features of patients with CBD stones with the high level of aminotransferase in serum.

First Posted: 2016-01-06

Condition(s): Choledocholithiasis

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 44

Allocation:

Sponsor: Gangnam Severance Hospital

Principal Investigator: Dong Ki Lee, Professor

Completion Date (primary or actual): 2013-10-01

CT.gov Identifier: NCT02647593

Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH

Randomized clinical trial of 11 days Cannabidiol versus placebo as an adjunctive treatment during inpatient alcohol detoxification to improve abstinence in patients with severe alcohol use disorder.

First Posted: 2023-05-16

Condition(s): Severe Alcohol Use Disorder (DSM 5)

Intervention(s): Placebo, Half dose CBD, Full dose CBD

Status: RECRUITING

Enrollment (expected or actual): 210

Allocation: RANDOMIZED

Sponsor: Assistance Publique - Hôpitaux de Paris

Principal Investigator:

Completion Date (primary or actual): 2026-05-23

CT.gov Identifier: NCT05860699

VRT as a Biomarker of Cerebellar Dysfunction in Chronic Cannabis Use

Chronic cannabis consumption has been associated with poor psychosocial functioning that could be associated to cerebellar dysfunction. The cerebellum has a relevant role in adaptation processes and has a high density of cannabinoid 1 receptor (CB1R). Implicit motor learning is a cerebellum dependent function that can be measured with a visuomotor rotation task (VRT). The project aims to identify a sensitive and specific biomarker of cerebellum dysfunction in chronic cannabis users. The investigators would like to demonstrate that the visuomotor rotation paradigm is valid to measure and quantify such a dysfunction. A longitudinal prospective study with a 3 month follow-up is proposed. 3 groups will be included: 1) chronic cannabis users; 2) individuals with an alcohol use disorder; and 3) healthy controls. All groups will be matched by sex and age. Forty individuals will be included in each group. Individuals will be assessed at baseline, at first month and at 3-months of follow-up. Sociodemographic and clinical data will be recorded. Information on cannabis consumption will be registered using an App. Participants will do the visuomotor rotation task and answer three questionnaires: the Intrinsic Motivation Inventory, the Scale for the assessment and rating of ataxia (SARA) and the Harris tests for lateral dominance. The biomarker developed by this project will facilitate the detection of cerebellar alterations in chronic cannabis users, and will permit to quantify and monitor such alteration over time. The team's intention is to patent the proposed model and disseminate it in order to use it in clinical practice at both primary and specialized health centres.

First Posted: 2018-09-07

Condition(s): Cannabis Use, Alcohol Use Disorder, Healthy

Intervention(s): Visuomotor adaptation task

Status: COMPLETED

Enrollment (expected or actual): 61

Allocation:

Sponsor: Hospital Clinic of Barcelona

Principal Investigator: Hugo López-Pelayo, MD, PhD, Head of Addiction Unit

Completion Date (primary or actual): 2021-12-31

CT.gov Identifier: NCT03662737

The Use of Cannabis (Marijuana) and Cannabidiol (CBD) Among Cancer Patients: A Pilot Study

To collect information about how patients in the pain management clinic use cannabis/CBD, including how often it is used, why it is used (for example, to manage pain or other symptoms), and where patients get their information on cannabis/CBD for pain management

First Posted: 2023-05-01

Condition(s): Cancer

Intervention(s): Cannabis (Marijuana), Cannabidiol (CBD)

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 100

Allocation:

Sponsor: M.D. Anderson Cancer Center

Principal Investigator:

Completion Date (primary or actual): 2027-05-31

CT.gov Identifier: NCT05836857

HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes

Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose which is absorbed from the intestine into the blood leading to a rise in glucose (blood sugar) which triggers the secretion of insulin. Insulin binds to cells in several tissues including liver, muscle, and fat, triggering cells to take up glucose and bring the blood glucose level back to normal. A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. High insulin levels also increase the incidence of cancers, stroke, and dementia. Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for insulin resistance may prevent the onset of diabetes or even reverse diabetes if diagnosed in its early stages before substantial damage to the pancreas has occurred. HP-211 is a botanical extract whose active ingredients are derived from herbs and vegetables present in normal diets. HP-211 has been shown in laboratory studies in cell culture, in animal studies, and in a previous Phase 1 study to enhance the ability of insulin to stimulate glucose uptake into cells. Thus, HP-211 may reduce the blood glucose and circulating insulin levels of subjects with type 2 diabetes after a meal. HP-211 may also reduce glucose and insulin responses to a greater extent in insulin-resistant as compared to insulin-sensitive subjects. Subjects will take 0, 1, 2 or 3 tablets of HP-211 in the morning and evening for 90 days. Hemoglobin A1c (HbA1c, or "A1c"), a measure of the average amount of glucose present in the blood, will be measured during the trial period.

First Posted: 2026-04-23

Condition(s): Type 2 Diabetes

Intervention(s): HP-211, Placebo

Status: RECRUITING

Enrollment (expected or actual): 300

Allocation: RANDOMIZED

Sponsor: Housey Healthcare ULC

Principal Investigator:

Completion Date (primary or actual): 2026-10

CT.gov Identifier: NCT07546929

Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail

This study will focus on treating substance abusing incarcerated teens using individually administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy (CBT). The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Currently, there is little research regarding effective group treatments for incarcerated teens and this study will address this gap in our knowledge base. We seek to reduce substance use and associated risky behaviors post-release (including driving under the influence, risky sexual behaviors, etc.)

First Posted: 2007-07-25

Condition(s): Alcohol Drinking, Marijuana Smoking

Intervention(s): MI/CBT, RT/SU

Status: COMPLETED

Enrollment (expected or actual): 205

Allocation: RANDOMIZED

Sponsor: University of Rhode Island

Principal Investigator: Lynda Stein, Ph.D., Professor

Completion Date (primary or actual): 2011-09

CT.gov Identifier: NCT00506753

Targeted Intervention on Sleep Disorders During Tobacco or Cannabis Cessation Therapy

During a cessation therapy for tobacco or cannabis, sleep disorders are one of the main risk factors of relapse, and a symptom of substance withdrawing. In this study, we make the hypothesis that identifying and managing potential sleep disorders during cessation treatment may contribute to maintain tobacco / cannabis abstinence on the long-term. To evaluate the impact of such intervention, we will conduct a randomised pilot study among patients consulting at two addiction prevention and care centres, for smoking or cannabis use cessation treatment. Control group will benefit of usual care (a multidisciplinary care with individual and group therapies); intervention group will benefit in addition of a systematic screening of sleep disorders, and in case of a diagnosed alteration, they will be addressed to the Chronos centre, for specific care to help them manage and reduce the consequences of their sleep disorders. Participants will be followed over a 6-month period, with visits at 1 and 3 months, to monitor smoking or cannabis cessation, and other criteria associated with their substance use or sleep.

First Posted: 2025-10-01

Condition(s): Sleep Disorder

Intervention(s): Screening and management of sleep disorders

Status: RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Centre Hospitalier St Anne

Principal Investigator: Pierre Alexis GEOFFROY, University professor and Hospital practitioner

Completion Date (primary or actual): 2026-08-31

CT.gov Identifier: NCT07202351

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

First Posted: 2018-01-16

Condition(s): Diffuse Cutaneous Systemic Sclerosis

Intervention(s): Lenabasum 5 mg, Lenabasum 20 mg, Placebo oral capsule

Status: TERMINATED

Enrollment (expected or actual): 365

Allocation: RANDOMIZED

Sponsor: Corbus Pharmaceuticals Inc.

Principal Investigator:

Completion Date (primary or actual): 2020-12-21

CT.gov Identifier: NCT03398837

Effects of Cannabis Species Labeling and Marketing on Perceptual, Subjective and Objective Use Outcomes (Aim 2 Study)

This study looks at how cannabis product label and marketing claims affect product perceptions, use expectancies, and use intentions among inexperienced and experienced cannabis users. Participants will answer online survey questions on their perceptions of a cannabis product advertisement.

First Posted: 2026-04-07

Condition(s): Cannabis Use

Intervention(s): Strain label, Claim

Status: COMPLETED

Enrollment (expected or actual): 3035

Allocation: RANDOMIZED

Sponsor: Johns Hopkins Bloomberg School of Public Health

Principal Investigator:

Completion Date (primary or actual): 2026-07-16

CT.gov Identifier: NCT07513337

Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.

A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso. Patients will be randomized to either placebo or active principle and be followed for 3 months. Assesment of efficacy and safety will be done by measurement of changes in their Fibromyalgia Impact Questionnaire (FIQ) score, Insomnia Severity Index (ISI) score, pain Visual Analogue Scale (VAS) score, plasma cytokine levels and detection of adverse effects. The active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (THC) and 0.45 milligrams cannabidiol (CBD) per drop.

First Posted: 2020-01-27

Condition(s): Fibromyalgia, Cannabis

Intervention(s): KL16-012, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 44

Allocation: RANDOMIZED

Sponsor: Knop Laboratorios

Principal Investigator:

Completion Date (primary or actual): 2020-09-15

CT.gov Identifier: NCT04239469

Cannabidiol as a Treatment for AUD Comorbid With PTSD

This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts to produce hypothesized effects are relatively well-understood, results may substantially advance understanding of the neurobiological basis of alcohol addiction.

First Posted: 2017-08-14

Condition(s): Alcohol Use Disorder, Post Traumatic Stress Disorder

Intervention(s): Cannabidiol, Placebos

Status: COMPLETED

Enrollment (expected or actual): 95

Allocation: RANDOMIZED

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): 2022-04-20

CT.gov Identifier: NCT03248167

Cannabidiol for the Treatment of Anxiety Disorders: An 8-Week Pilot Study

This proposed study aims to evaluate the efficacy of daily Cannabidiol (CBD) Oil Capsules in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. The study will also evaluate the relationship between inflammation, anxiety and CBD using biological markers as well as examine the neuro-cognitive effects of CBD treatment.

First Posted: 2018-06-08

Condition(s): Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia

Intervention(s): Cannabidiol (CBD) Oil Capsules, Sunflower Lecithin Oil in Capsule

Status: UNKNOWN

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: McMaster University

Principal Investigator:

Completion Date (primary or actual): 2024-02

CT.gov Identifier: NCT03549819

Immune Disorder HSCT Protocol

This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.

First Posted: 2013-04-01

Condition(s): Immune Deficiency Disorders, Severe Combined Immunodeficiency, Chronic Granulomatous Disease, X-linked Agammaglobulinemia, Wiskott-Aldrich Syndrome, Hyper-IgM, DiGeorge Syndrome, Chediak-Higashi Syndrome, Common Variable Immune Deficiency, Immune Dysregulatory Disorders, Hemophagocytic Lymphohistiocytosis, IPEX, Autoimmune Lymphoproliferative Syndrome, X-linked Lymphoproliferative Syndrome

Intervention(s): Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: Washington University School of Medicine

Principal Investigator:

Completion Date (primary or actual): 2026-04

CT.gov Identifier: NCT01821781

Alerta Cannabis: Evaluation of Web-based Tailored Intervention

This study consists in the the design, implementation, and evaluation of the first web-based computer tailored intervention program aimed at the prevention of cannabis use in Spanish adolescents (ALERTA CANNABIS). A Cluster Randomized Controlled Trial is conducted to test the effectiveness of ALERTA CANNABIS in students aged 14 to 18 years across 34 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC).

First Posted: 2023-05-09

Condition(s): Cannabis Use, Adolescent Behavior, E-health

Intervention(s): ALERTA CANNABIS

Status: UNKNOWN

Enrollment (expected or actual): 1850

Allocation: RANDOMIZED

Sponsor: University of Seville

Principal Investigator: Marta Lima-Serrano, PhD, Associate Professor

Completion Date (primary or actual): 2024-01-31

CT.gov Identifier: NCT05849636

Cannabis Oil for Pain in Parkinson's Disease

Full Title: A phase II, randomized, open-label, double-blind, two-center study to evaluate the tolerability, safety and dose-finding of oil cannabis preparation for pain in Parkinson's disease. Short title: Cannabis oil for pain in Parkinson's disease Sample Size: N = 15 Study Population: Patients with Parkinson's disease and pain, without cognitive impairment. Study Duration: July 2018 - July 2019 Study Agent/ Intervention: Cannabis oil: mixed oil cannabis preparation consisting of 3 different formulations of ∆-9THC and cannabidiol - 18:0; 10:10; and 1:20 respectively. Cannabis oil will be administered orally once per day, as required for pain; or taken 4h before bedtime, if no pain. Primary objective: to determine the safety and tolerability of different formulations of Cannabis oil for pain in PD patients (incidence and severity of adverse events). Secondary objective: to assess change from the start of treatment (V2) to end of treatment (V5) in frequency and severity of pain, sleep, dystonia and motor symptoms in PD patients.

First Posted: 2018-08-20

Condition(s): Parkinson Disease

Intervention(s): Cannabis Oil

Status: UNKNOWN

Enrollment (expected or actual): 15

Allocation: RANDOMIZED

Sponsor: University Health Network, Toronto

Principal Investigator:

Completion Date (primary or actual): 2022-12

CT.gov Identifier: NCT03639064

Investigation of the Efficacy and Safety of CHI-921 in Insomnia.

Insomnia is a disorder where people are having trouble sleeping and can include difficulty falling asleep, staying asleep and waking up too early, as well as having unrefreshing sleep. CHI-921 is a cannabis extract in sunflower oil produced as a treatment for insomnia. This trial is designed to evaluate the efficacy and safety of CHI-921 on people with insomnia.

First Posted: 2019-06-13

Condition(s): Insomnia

Intervention(s): CHI-921, Placebo

Status: TERMINATED

Enrollment (expected or actual): 21

Allocation: RANDOMIZED

Sponsor: Canopy Growth Corporation

Principal Investigator:

Completion Date (primary or actual): 2020-06-17

CT.gov Identifier: NCT03984604

EffectS of CAnnabidiol in Patients: Evaluation

Since its recent marketizing in France, the cannabidiol (CBD), a major component of cannabis, is used in many over-the-counter products in France. Some painful patients or patients suffering from addiction seem to use the CBD in search of therapeutic effects. Yet, there are no data available for patients in algology and addictology, particularly with regard to the prevalence of the use of CBD, the effects sought and felt. Faced with the emergence of the use of a substance with a therapeutic purpose but outside a medical framework and without monitoring of adverse effects, it becomes essential to characterize the use of CBD. The main objective of the study is therefore to assess the prevalence of CBD users in algology and addictology departments. Secondary objectives are to characterize the use of CBD as well as the users of CBD, and to evaluate the impact of the use of CBD on other psychoactive substances use or current drug treatments and the drug liking of CBD.

First Posted: 2020-05-28

Condition(s): Substance-Related Disorders

Intervention(s): Form

Status: COMPLETED

Enrollment (expected or actual): 746

Allocation:

Sponsor: Nantes University Hospital

Principal Investigator:

Completion Date (primary or actual): 2021-07-26

CT.gov Identifier: NCT04405414

Reward and Drug Effects on Mood and Brain Response

The goal of the study is to better understand the neural mechanisms underlying the rewarding, reinforcing properties of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, among healthy young adults.

First Posted: 2020-08-13

Condition(s): Cannabis Use, Healthy

Intervention(s): Placebo oral capsule, THC

Status: COMPLETED

Enrollment (expected or actual): 141

Allocation: RANDOMIZED

Sponsor: University of Illinois at Chicago

Principal Investigator: Natania A Crane, Assistant Professor

Completion Date (primary or actual): 2025-05-02

CT.gov Identifier: NCT04512365

Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With "Wearingoff" Phenomenon

The purpose of this study was to investigate the effect on the "wearing-off" phenomenon of 3 different doses of nebicapone (NEB 50 mg, 100 mg and 150 mg), compared with entacapone and placebo when dministered concomitantly with existing treatment with levodopa plus a dopa decarboxylase inhibitor (DDCI: carbidopa or benserazide).

First Posted: 2017-04-06

Condition(s): Parkinson Disease

Intervention(s): Comtan®, Nebicapone, Levodopa/DDCI, Placebo

Status: COMPLETED

Enrollment (expected or actual): 254

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2007-09-21

CT.gov Identifier: NCT03103399

Unrelated Hematopoietic Stem Cell Transplantation(HSCT) for Genetic Diseases of Blood Cells

This is a clinical trial of bone marrow transplantation for patients with the diagnosis of a genetic disease of blood cells that do not have an HLA-matched sibling donor. Genetic diseases of blood cell include: Red blood cell defects e.g. hemoglobinopathies (sickle cell disease and thalassemia), Blackfan-Diamond anemia and congenital or chronic hemolytic anemias; White blood cells defects/immune deficiencies e.g. chronic granulomatous disease, Wiskott-Aldrich syndrome,Osteopetrosis, Kostmann's syndrome (congenital neutropenia), Hereditary Lymphohistiocytosis (HLH); Platelets defects e.g.Congenital amegakaryocytic thrombocytopenia; Metabolic/storage disorders e.g. leukodystrophies,mucopolysaccharidoses as Hurler disease;Stem cell defects e.g.reticular agenesis, among many other rare similar conditions. The study treatment plan uses a new transplant treatment regimen that aims to try to decrease the acute toxicities and complications associated with the standard treatment plans and to improve outcome The blood stem cells will be derived from either unrelated donor or unrelated umbilical cord blood.

First Posted: 2008-08-08

Condition(s): Sickle Cell Disease, Thalassemia, Anemia, Granuloma, Wiskott-Aldrich Syndrome, Chediak Higashi Syndrome, Osteopetrosis, Neutropenia, Thrombocytopenia, Hurler Disease, Niemann-Pick Disease, Fucosidosis

Intervention(s): Hematopoietic stem cell transplantation

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: NON_RANDOMIZED

Sponsor: Children's Hospital Los Angeles

Principal Investigator: Hisham Abdel-Azim, Principle Investigator

Completion Date (primary or actual): 2015-08

CT.gov Identifier: NCT00730314

A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease

The major purpose of the Stage 1 is to study the safety and tolerability of the proposed dosage regimen of the study drug. The form of cannabidiol (CBD) used in this study is GWP42003, supplied by GW Pharmaceuticals. The dosage regime is based on their experience. This is an open label study in 10 subjects, during which the dose is gradually increased to the manufacturers recommended target dose, with tolerability being evaluated at each dose level. Based on the response of subjects in the Stage 1, a target dose is determined for the next stage. Standardized tools will be administered to study both tolerability and efficacy. Efficacy assessments are simply explorative, and are done to look for an effect that warrants specific or different evaluation in the next stage.

First Posted: 2016-06-30

Condition(s): Parkinson's Disease

Intervention(s): cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 13

Allocation: NA

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2017-11

CT.gov Identifier: NCT02818777

Social and Emotional Brain Function in Cannabis Users

The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and how social and emotional brain function are altered in dependent cannabis users relative to healthy non-using control subjects after a 28 supervised abstinence period. Previous research in cannabis users has predominantly focused on cognitive functions. Moreover, studies have implicated that observed deficits in cannabis users may regenerate after a prolonged abstinence period. Findings might provide important information with respect to relapse vulnerability.

First Posted: 2016-03-17

Condition(s): Cannabis Dependence

Intervention(s): fMRI

Status: COMPLETED

Enrollment (expected or actual): 43

Allocation:

Sponsor: University of Electronic Science and Technology of China

Principal Investigator: Benjamin Becker, Prof. Dr. rer. nat.

Completion Date (primary or actual): 2016-12

CT.gov Identifier: NCT02711371

Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct

Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.

First Posted: 2013-01-18

Condition(s): Post-ERCP Pancreatitis

Intervention(s): Loop-tip wire (Cook Medical) for the cannulation of the CBD, Cannulotome CT-25mm Cook Medical

Status: UNKNOWN

Enrollment (expected or actual): 320

Allocation: RANDOMIZED

Sponsor: Hospital San Paolo

Principal Investigator: Benedetto Mangiavillano, MD

Completion Date (primary or actual): 2014-01

CT.gov Identifier: NCT01771419

Assessment of the Effectiveness of an Integrative Therapy for Cannabis Misuse in Adolescents

The primary objective of this study is to evaluate an Integrative Therapy for Adolescent Cannabis Use (TIMCA), integrating elements of Motivational Interviewing (MI), Cognitive Behavioral Therapies (CBT) and an Attachment-Based Intervention (ABI), (IBA),compared to Treatment As Usual (TAU) on cannabis use. The secondary objectives of the study are: To assess the effectiveness of the TIMCA, in comparison to the TAU, on: (1) Relationship quality with parents, (2) Relationship quality with closest friend, (3) Emotional regulation strategies, (4) Depressive symptomatology, (5) Anxiety symptomatology, (6) Adherence to therapy

First Posted: 2023-03-13

Condition(s): Cannabis Use Disorder

Intervention(s): TIMCA, Treatment as Usual

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Centre Hospitalier St Anne

Principal Investigator:

Completion Date (primary or actual): 2025-06-09

CT.gov Identifier: NCT05765409

The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy

This will be an open-label, single group supportive care pilot study in which patients are given cannabinoid gummies in the perioperative setting to alleviate RC/UD symptoms and improve quality of life. The primary objective will be to evaluate the safety and tolerability of a cannabigerol supplement used perioperatively (from 14 days prior to surgery to 30 days following surgery) by patients undergoing radical cystectomy with urinary diversion (RC/UD).

First Posted: 2026-05-11

Condition(s): Non-metastatic Bladder Cancer

Intervention(s): Cannabigerol

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: Stanford University

Principal Investigator:

Completion Date (primary or actual): 2028-05

CT.gov Identifier: NCT07577999

Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

Suicide is a major crisis worldwide with rates projected to continue to increase. There is currently a dearth of novel pharmacologic treatment options for suicide available on the market. The endocannabinoid system has been recently shown to be associated with mood disorders including suicidality. The aim of the study is to determine whether treatment with Nabilone is capable of reducing suicidal ideation in adults after 3 days.

First Posted: 2021-03-19

Condition(s): Suicidal Ideation

Intervention(s): Nabilone, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: The University of Texas Health Science Center, Houston

Principal Investigator: Rodrigo Machado-Vieira, MD, PhD, MSc, Professor of Psychiatry

Completion Date (primary or actual): 2022-04

CT.gov Identifier: NCT04807829

Consequences of Marijuana Use in HIV-infected Youth

Proposed study focuses on Youth With HIV (YWH) recruited from the University of North Carolina using a cross sectional assessment of blood samples, clinical, demographic, behavioral, \[including substance use and frequency\], and neurocognitive data will be evaluated from YWH treated before CD4 T cell decline.

First Posted: 2019-04-25

Condition(s): Youth With HIV

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 21

Allocation:

Sponsor: Duke University

Principal Investigator:

Completion Date (primary or actual): 2021-10-15

CT.gov Identifier: NCT03927053

CBD, Immune Function, and Neural Health

Chronic inflammation, which is defined as a persistent, low-grade inflammatory response within the body, is associated with many of the negative health conditions which are prevalent in our society today. It is most well-known for its role in the progression of diseases including obesity, metabolic syndrome, cancer, cardiovascular disease, and diabetes. Chronic inflammation is also linked to many of the underlying factors associated with disease development including perturbations in sleep, and mental health status such as depression, anxiety, fatigue, and quality of life. Natural killer cells, commonly referred to as NK cells, are a subset of white blood cells that play an important role in the coordination of inflammation in the body. Although many interventions aimed at controlling chronic inflammation and enhancing NK cell number and activity have been explored, relatively few have been administered without significant barriers. Cannabidiol (CBD), a non-psychoactive hemp derivative, is a potential, attractive therapeutic target. However, there is very little information in humans that addresses the potential of CBD to improve your health and immune function. The overall goal of this study is to explore the effects of 8-weeks of CBD supplementation on mental and physical health, sleep measures, and NK cell number and cytotoxic function. Specific Aim 1. Explore the effect of 8-weeks of CBD administration on sleep measures as well as measures of mental and physical health in conjunction with measurements of NK cell number and function.

First Posted: 2021-05-11

Condition(s): Healthy

Intervention(s): Cannabidiol (CBD)

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: University of Northern Colorado

Principal Investigator: Laura Stewart, Professor

Completion Date (primary or actual): 2022-03-18

CT.gov Identifier: NCT04881539

Culturally Adapted EAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Pilot Study

The goal of this clinical trial is to evaluate whether a culturally adapted group-based emotional therapy named "Emotional Awareness and Expression Therapy" can help reduce chronic pain and improve emotional well-being in Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Researchers will compare patients who receive the emotional therapy along with their usual care to patients who receive usual care only, to see if the therapy leads to better outcomes in pain, mental health, and daily functioning. Participants will attend a weekly 1.5-hour group therapy session for 8 weeks; Take part in group discussions and emotional processing exercises; Complete questionnaires about pain levels, mood, sleep, and quality of life; Continue their usual medical treatment as prescribed by their doctors.

First Posted: 2025-09-11

Condition(s): Chronic Musculoskeletal Pain, Cannabis Use

Intervention(s): Group-based Emotional Awareness & Expression Therapy - Hebrew

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: NA

Sponsor: Reuth Rehabilitation Hospital

Principal Investigator:

Completion Date (primary or actual): 2025-12-08

CT.gov Identifier: NCT07168707

A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration

The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.

First Posted: 2008-06-23

Condition(s): Progressive Supranuclear Palsy, Corticobasal Degeneration

Intervention(s): Lithium

Status: COMPLETED

Enrollment (expected or actual): 17

Allocation: NA

Sponsor: Westat

Principal Investigator:

Completion Date (primary or actual): 2010-01

CT.gov Identifier: NCT00703677

Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

This pilot study is being conducted as a prelude to a randomized trial to compare levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to demonstrate recruitment potential, to provide prospective data on the tolerability of levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide limited data on it's efficiency, and to provide data to assist in selecting a dose to use in a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity for investigators to gain experience in using levodopa prior to a randomized trial.

First Posted: 2008-11-13

Condition(s): Amblyopia

Intervention(s): levodopa/carbidopa, patching, levodopa/carbidopa

Status: COMPLETED

Enrollment (expected or actual): 33

Allocation: RANDOMIZED

Sponsor: Jaeb Center for Health Research

Principal Investigator: Ray Kraker, Director, PEDIG Coordinating Center

Completion Date (primary or actual): 2009-12

CT.gov Identifier: NCT00789672

Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders

The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery.

First Posted: 2024-05-29

Condition(s): Trauma

Intervention(s): Patient questionnaires

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: NA

Sponsor: Hôpital NOVO

Principal Investigator:

Completion Date (primary or actual): 2025-12

CT.gov Identifier: NCT06432400

Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults

The goal of this clinical trial is to determine 1) feasibility of the MOMENT-V intervention for cannabis use disorder in young adults, 2) feasibility of conducting the trial remotely, and 3) whether the MOMENT-V intervention reduces cannabis use frequency and problems. Researchers will compare the MOMENT-V intervention to usual care enhanced by a counselor meeting. Participants will either meet with a counselor two times and use an app on their phone for two weeks, or meet with a counselor briefly one time. All participants will be asked to complete electronic surveys, interviews with a research assistant, and saliva drug testing at home over three months.

First Posted: 2024-10-28

Condition(s): Cannabis Use Disorder

Intervention(s): Motivational Enhancement Therapy plus Ecological Momentary Intervention, Enhanced Usual Care

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 65

Allocation: RANDOMIZED

Sponsor: Boston Children's Hospital

Principal Investigator: Lydia Shrier, Research Director, Division of Adolescent/Young Adult Medicine

Completion Date (primary or actual): 2027-05

CT.gov Identifier: NCT06661031

Metformin in Parkinson Disease

The clinical manifestations of Parkinson's disease (PD), a chronic neurodegenerative condition, include resting tremor, hypokinesia, bradykinesia, stiffness and postural instability. These motor symptoms are caused by a selective loss and degeneration of dopaminergic neurons in the substantia nigra pars compacta (SNpc) region, which leads to a dopamine (DA) insufficiency in the striatum

First Posted: 2025-11-17

Condition(s): Parkinson Disease

Intervention(s): Levodopa Carbidopa, Metformin

Status: RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Tanta University

Principal Investigator: Ihab Elsayed Hassan, Lecturer

Completion Date (primary or actual): 2027-09-20

CT.gov Identifier: NCT07229651

Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains

Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development. The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin infiltration is a novel method that has shown its efficacy in improving the esthetics of various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ and in-vivo studies. The Resin Infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions. Therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and Resin infiltration therapy in children with fluorosed teeth.

First Posted: 2012-11-27

Condition(s): Caries Infiltration, Fluorosis, Dental Care

Intervention(s): Office Bleaching, Resin Infiltration, Resin Infiltration twice, Bleaching + Resin Infiltration

Status: COMPLETED

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: DMG Dental Material Gesellschaft mbH

Principal Investigator:

Completion Date (primary or actual): 2014-05

CT.gov Identifier: NCT01733888

Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms

Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available. This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies. The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.

First Posted: 2015-09-16

Condition(s): Spasms, Infantile

Intervention(s): Cannabidiol Oral Solution

Status: TERMINATED

Enrollment (expected or actual): 9

Allocation: NA

Sponsor: INSYS Therapeutics Inc

Principal Investigator:

Completion Date (primary or actual): 2016-09-06

CT.gov Identifier: NCT02551731

A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.

First Posted: 2009-08-07

Condition(s): Parkinson's Disease

Intervention(s): istradefylline

Status: COMPLETED

Enrollment (expected or actual):

Allocation:

Sponsor: Kyowa Kirin, Inc.

Principal Investigator:

Completion Date (primary or actual): 2003-10

CT.gov Identifier: NCT00955045

Resting-state Imaging and Chronic Consumption of Non-Nutritive SweetenerS

Non-nutritive sweeteners are used as a substitute for simple sugars to improve the palatability of food products without increasing their sugar and calorie content. They represent a global market of 7 billion euros, with an annual growth of 5%. Reducing their consumption therefore seems to be excluded. Some studies have focused on the impacts of these substances on brain activity. According to a recent study, continuous consumption of low doses of saccharin in adult mice significantly decreases the level of dopamine in the prefrontal cortex and significantly increases striatal dopamine, which modifies decision-making strategies. Resting-state functional Magnetic Resonance Imaging (r-fMRI) studies in humans have also shown that an increase in striatal dopaminergic activity modifies the resting-state functional connectivity of brain regions linked to the reward circuit. r-fMRI allows the characterization of brain networks and the strength of correlations between brain regions, without any specific task being required. It is a rapid, non-invasive technique that can measure changes in brain functional connectivity. In addition to r-fMRI, diffusion tensor imaging (DTI) is able to assess white matter microstructure and the integrity or otherwise of fiber tracts. Several parameters such as the fractional anisotropy (FA), coefficient of white matter, mean diffusivity, and radial diffusivity can be modified in the event of changes in functional connectivity, reflecting axonal rearrangements, not visible on conventional MRI sequences. Based on previous research, investigators hypothesize that (1) chronic consumption of non-nutritive artificial sweeteners increases striatal dopaminergic activity. (2) This modification is accompanied by changes in resting-state functional connectivity in brain regions of interest associated with the reward circuit in healthy young adults. Then, the primary objective of this study is to compare, in the resting state, the differences in functional connectivity of brain regions of interest between "non/low consumers" and "high consumers" of sweeteners at the start of the study using r-fMRI. The key secondary objective of this study is to assess changes in brain connectivity using r-fMRI in non- and low-consuming subjects before and after a transient increase in their sweetener consumption over 5 weeks. The secondary objectives include assessing daily sugar consumption (5-week follow-up), daily consumption of non-energy-rich artificial sweeteners (5-week follow-up), Body Mass Index (BMI), physical activity level, and white matter microstructure and fibrous tract integrity using a diffusion-weighted MRI (DTI) sequence.

First Posted: 2025-09-19

Condition(s): Healthy Volunteers - Male and Female

Intervention(s): administration of questionnaires, carrying out a MRI scan, Can distribution visit for subjects in the "non/low" sweetener consumption group, carrying out a MRI scan

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 100

Allocation: NON_RANDOMIZED

Sponsor: University Hospital, Clermont-Ferrand

Principal Investigator:

Completion Date (primary or actual): 2027-12-01

CT.gov Identifier: NCT07183254

Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer

This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient?s immune cells and help destroy any remaining cancer cells.

First Posted: 2017-11-07

Condition(s): Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Aplastic Anemia, B-Cell Non-Hodgkin Lymphoma, CD40 Ligand Deficiency, Chronic Granulomatous Disease, Chronic Leukemia in Remission, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Congenital Amegakaryocytic Thrombocytopenia, Congenital Neutropenia, Congenital Pure Red Cell Aplasia, Glanzmann Thrombasthenia, Immunodeficiency Syndrome, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Paroxysmal Nocturnal Hemoglobinuria, Plasma Cell Myeloma, Polycythemia Vera, Recurrent Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome, Severe Aplastic Anemia, Shwachman-Diamond Syndrome, Sickle Cell Disease, T-Cell Non-Hodgkin Lymphoma, Thalassemia, Waldenstrom Macroglobulinemia, Wiskott-Aldrich Syndrome

Intervention(s): Cyclophosphamide, Fludarabine Phosphate, Laboratory Biomarker Analysis, Peripheral Blood Stem Cell Transplantation, Total-Body Irradiation

Status: TERMINATED

Enrollment (expected or actual): 31

Allocation: NA

Sponsor: Roswell Park Cancer Institute

Principal Investigator:

Completion Date (primary or actual): 2023-08-28

CT.gov Identifier: NCT03333486

INfusion VErsus STimulation in Parkinson's Disease

Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no comparative studies have been executed. The INVEST study is an open label randomised controlled trial with cost-effectiveness as primary outcome. The main clinical outcome is quality of life; secondary outcomes are motor symptoms and neurological impairments, among others.

First Posted: 2015-06-25

Condition(s): Parkinson's Disease

Intervention(s): Continuous intrajejunal infusion of levodopa-carbidopa, deep brain stimulation

Status: COMPLETED

Enrollment (expected or actual): 51

Allocation: RANDOMIZED

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Principal Investigator: J.M. Dijk, J.M. Dijk, MD, PhD, Neurologist, Principal Investigator

Completion Date (primary or actual): 2024-01-26

CT.gov Identifier: NCT02480803

Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement

Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention. Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain and for renal colic.

First Posted: 2021-03-25

Condition(s): Acute Radicular Back Pain, Cannabis

Intervention(s): Single-dose of cannabis oil, Control

Status: RECRUITING

Enrollment (expected or actual): 200

Allocation: RANDOMIZED

Sponsor: Hadassah Medical Organization

Principal Investigator:

Completion Date (primary or actual): 2025-12-31

CT.gov Identifier: NCT04816994

Cannabidiol's Role in Dementia Management

This trial investigates the therapeutic benefits of cannabidiol (CBD) for Dementia patients in Malaysia. As dementia becomes increasingly prevalent worldwide, there's a pressing demand for impactful remedies. This research will delve into CBD's influence on cognitive functions, daily activities, mental health, and overall life quality of dementia sufferers. Utilizing a range of established assessment instruments, including the ADAS-COG subscale for cognitive effects, the NPI score for psychological well-being, and the QOLAD questionnaire for life quality, we aim to discern CBD's potential in ameliorating the conditions of those with dementia. This study's results could shape novel treatment methods and improved care for dementia patients, benefiting not just Malaysia but the world at large.

First Posted: 2024-07-23

Condition(s): Dementia, Vascular, Dementia, Mixed

Intervention(s): Cannabidiol Oil

Status: UNKNOWN

Enrollment (expected or actual): 486

Allocation: RANDOMIZED

Sponsor: Hospital Pengajar Universiti Putra Malaysia

Principal Investigator:

Completion Date (primary or actual): 2025-10-01

CT.gov Identifier: NCT06514066

The Relationship Between Cannabis Use, Biomarkers, Tissue Cannabinoid Levels and Clinical Outcomes in Patients With OA

Osteoarthritis (OA), the most common form of arthritis, is a leading cause of disability, affecting the quality of life, pain, and physical functioning of 4.6 million Canadians. About half of OA patients have limited response to primary therapy. The number of OA patients continues to rise, affecting the quality of life of those with OA. There is a dire need to develop future effective treatment options. Cannabis is a potential therapy for those with OA and may provide analgesic, anti-inflammatory, and disease modifying effects. The common barriers to use are a lack of knowledge regarding efficacy, access, and commonly used products, doses and routes of administration. No high-quality clinical trials of cannabis for OA have been conducted, leaving physicians struggling to guide and inform patients regarding symptom relief. Findings from clinical trials of cannabis for other painful conditions have been variable, perhaps due to suboptimal cannabis products and failure to consider important patient characteristics. The goal of the current study is to characterize patient- and cannabis-level factors that are associated with OA pain and address other knowledge gaps.

First Posted: 2021-07-21

Condition(s): Osteo Arthritis Knee

Intervention(s):

Status: UNKNOWN

Enrollment (expected or actual): 1200

Allocation:

Sponsor: University Health Network, Toronto

Principal Investigator: Hance Clarke, Director Pain Services, Toronto General Hospital

Completion Date (primary or actual): 2025-06-30

CT.gov Identifier: NCT04971629

Guiding Good Choices for Health

This study evaluates the feasibility and effectiveness of implementing Guiding Good Choices (GGC), an anticipatory guidance curriculum for parents of early adolescents, in three large, integrated healthcare systems. By "parents," the study team is referring here and throughout this protocol to those adults who are the primary caregivers of children, irrespective of their biological relationship to the child. In prior community trials, GGC has been shown to prevent adolescent substance use (alcohol, tobacco, and marijuana), depressive symptoms, and delinquent behavior. This study offers an opportunity to test GGC effectiveness with respect to improving adolescent behavioral health outcomes when implemented at scale in pediatric primary care within a pragmatic trial.

First Posted: 2019-07-31

Condition(s): Adolescent Substance Use

Intervention(s): Guiding Good Choices

Status: UNKNOWN

Enrollment (expected or actual): 3636

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Margaret Kuklinski, Research Scientist

Completion Date (primary or actual): 2025-05-31

CT.gov Identifier: NCT04040153

Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) \[LD/CD\] in advanced PD participants to achieve reduction in motor fluctuations. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world. In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

First Posted: 2020-05-08

Condition(s): Parkinson's Disease (PD)

Intervention(s): ABBV-951, Placebo for Levodopa/Carbidopa (LD/CD), Levodopa/Carbidopa (LD/CD), Placebo for ABBV-951

Status: COMPLETED

Enrollment (expected or actual): 174

Allocation: RANDOMIZED

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2021-09-29

CT.gov Identifier: NCT04380142

Dose Ranging Study of Carbidopa-levodopa

From 3 large patient databases, patients diagnosed with AMD who have never taken levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD at 79 years. L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects the retina and downregulates VEGF, which is the cause of neovascularization. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and measure the effects on visual acuity, retinal abnormalities due to "wet" AMD, and document the number of anti-VEGF injections required during the study.

First Posted: 2017-01-18

Condition(s): Age-related Macular Degeneration

Intervention(s): Carbidopa-Levodopa, 25 Mg-100 Mg Oral Tablet

Status: COMPLETED

Enrollment (expected or actual): 35

Allocation: NA

Sponsor: Snyder, Robert W., M.D., Ph.D., P.C.

Principal Investigator:

Completion Date (primary or actual): 2020-05-04

CT.gov Identifier: NCT03023059

Combined THC and CBD Drops for Treatment of Crohn's Disease

There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.

First Posted: 2013-04-08

Condition(s): Crohn's Disease

Intervention(s): THC 5mg/ml and CBS 50mg/ml, Placebo

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Meir Medical Center

Principal Investigator:

Completion Date (primary or actual): 2018-06

CT.gov Identifier: NCT01826188

Targeted Literature Review and Subject Interviews in Wiskott-Aldrich Syndrome (WAS)

WAS is a rare primary immune deficiency disease caused by genetic mutation and is more common in males than females. The purpose of this study is to understand experiences of WAS subjects and caregivers to identify important concepts of interest that could be measured in future Phase IIIb trials. This is a qualitative cross-sectional study that will include a sample of approximately, 8 subjects with WAS and 13 caregivers of subjects with a diagnosis of WAS in the United States, United Kingdom and France. A 60 to 90 minute open-ended interview will be conducted over the telephone or video conference that will be audio-recorded for subsequent transcription. The aim of these interviews is to obtain subject and caregiver perspectives on the impact of WAS and its associated treatments on quality of life and experiences of living with WAS.

First Posted: 2018-01-16

Condition(s): Wiskott-Aldrich Syndrome

Intervention(s): Patient Interview guide, Caregiver interview guide, Sociodemographic questionnaire, Pediatric quality of life (PedsQL) questionnaire, Clinical questionnaire

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation:

Sponsor: GlaxoSmithKline

Principal Investigator:

Completion Date (primary or actual): 2018-09-14

CT.gov Identifier: NCT03399461

Levodopa for the Treatment of Residual Amblyopia

The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to \<13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.

First Posted: 2010-08-30

Condition(s): Amblyopia

Intervention(s): Levodopa/Carbidopa, Placebo, Patching

Status: COMPLETED

Enrollment (expected or actual): 139

Allocation: RANDOMIZED

Sponsor: Jaeb Center for Health Research

Principal Investigator:

Completion Date (primary or actual): 2014-04

CT.gov Identifier: NCT01190813

Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

This human laboratory study aims to assess the effects of cannabidiol on alcohol consumption and craving in participants with alcohol use disorder. In this double-blind within-subject placebo-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.

First Posted: 2024-07-22

Condition(s): Alcohol Use Disorder

Intervention(s): Oral solution

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2026-09-30

CT.gov Identifier: NCT06512389

COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel

The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD) patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical setting.

First Posted: 2017-12-05

Condition(s): Parkinson's Disease (PD)

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 412

Allocation:

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): 2018-12-17

CT.gov Identifier: NCT03362879

Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing

In this new research study, 80 adults aged \> 60 years with a significant depressive disorder and slowed processing and/or gait speed will be randomized to receive levodopa (L-DOPA; which the Candidate has previously shown to increase psychomotor speed and decrease depressive symptoms in older adults), aerobic exercise (itself an effective antidepressant treatment as monotherapy), or their combination in a 2x2 design incorporating placebo and a stretching/toning control. Participants will be evaluated before and after this 12-week duration study across cognitive domains, psychiatric symptoms, gait kinematics and mobility, and task-based magnetic resonance imaging (MRI) focused on effort-based decision making and reward processing. Data from this study will contribute toward the development of improved treatment and prevention strategies to maximize the functioning and active healthspan of older adults with neuropsychiatric disorders.

First Posted: 2020-12-02

Condition(s): Depressive Disorder

Intervention(s): Carbidopa/levodopa, Placebo, Exercise training, Control

Status: TERMINATED

Enrollment (expected or actual): 1

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Bret Rutherford, Associate Professor of Clinical Psychiatry

Completion Date (primary or actual): 2021-12-31

CT.gov Identifier: NCT04650217

vEAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Feasibility Study

The goal of this clinical trial is to evaluate whether a culturally adapted, virtual, group-based emotional therapy called Emotional Awareness and Expression Therapy is feasible and whether it can help reduce chronic pain and improve emotional well-being among Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Participants will attend a weekly 1.5-hour virtual group therapy session for 8 weeks, except for the first session, which will be held in-person at the hospital's clinic. The participants will take part in group discussions and emotional processing exercises, complete questionnaires about pain levels, mood, sleep, and quality of life, and continue their usual medical treatment as prescribed by their doctors.

First Posted: 2026-07-28

Condition(s): Chronic Musculoskeletal Pain, Cannabis Use

Intervention(s): Group-based virtual Emotional Awareness & Expression Therapy - Hebrew (vEAET-H)

Status: RECRUITING

Enrollment (expected or actual): 42

Allocation: NA

Sponsor: Reuth Rehabilitation Hospital

Principal Investigator:

Completion Date (primary or actual): 2027-10-01

CT.gov Identifier: NCT07732062

Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans

After initial eligibility screening, Veterans who use both cannabis and tobacco will be randomly assigned to receive either varenicline (Chantix) or placebo for 12 weeks. Participants will attend weekly visits, in person or remotely, to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.

First Posted: 2022-03-24

Condition(s): Tobacco Use Disorder, Cannabis Use Disorder

Intervention(s): Varenicline, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: NON_RANDOMIZED

Sponsor: VA Office of Research and Development

Principal Investigator:

Completion Date (primary or actual): 2024-07-17

CT.gov Identifier: NCT05294263

A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.

First Posted: 2012-04-02

Condition(s): Parkinson's Disease

Intervention(s): BIA 9-1067, BIA 9-1067, BIA 9-1067, Placebo, Levodopa/Carbidopa, Levodopa/Benzerazide

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2010-02

CT.gov Identifier: NCT01568034

Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region

The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) vs placebo (hemp oil) will provide pain relief and improved jaw function in those who suffer from either myofascial pain disorder and/or arthralgia of the temporomandibular region. 1. Primary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in jaw pain. 2. Secondary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in function of the temporomandibular joint. 3. Exploratory Objectives To determine if there are any adverse effects that result from the consumption of CBD oil or placebo.

First Posted: 2020-03-06

Condition(s): TMJ Disorder, Myofacial Pain, TMD

Intervention(s): CBD Oil, Hemp Oil

Status: COMPLETED

Enrollment (expected or actual): 59

Allocation: RANDOMIZED

Sponsor: Weill Medical College of Cornell University

Principal Investigator:

Completion Date (primary or actual): 2022-05-29

CT.gov Identifier: NCT04298554

Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome

To evaluate the efficacy of cannabidiol oral solution (GWP42003-P, CBD-OS) in reducing symptom severity when compared with placebo, in participants with Rett syndrome.

First Posted: 2019-02-21

Condition(s): Rett Syndrome, RTT

Intervention(s): GWP42003-P, Placebo

Status: TERMINATED

Enrollment (expected or actual): 29

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2021-01-21

CT.gov Identifier: NCT03848832

Exposure in Epigenetic Regulation of Immune Response in Chronic Beryllium Disease (CBD)

This study will provide important results for each aim, while also providing an integrative transcriptional and epigenomic profile of CBD. In Aim 1 the Investigator will define genome-wide epigenetic alterations of CBD, by determining genes that are DM in pivotal immune cells, in the target organ (CD4+ BAL cells) in CBD compared to BeS and healthy controls. In addition, the Investigator will determine the impact of Be exposure on the methylation profile of CBD and BeS cells compared to each other and normal controls. This information will be used to define DM regions, genes and their networks. Using the cases and controls from Aim 1, we will evaluate the gene-expression from these same subjects in Aim 2 to define functional epigenetic loci based on DE in CD4+ BAL cells with and without Be exposure. The Investigator will also integrate ENCODE/RE methylation, histone modification, and chromatin accessibility data as well as our genome-wide association study (GWAS) data to prioritize epigenetic marks and networks for confirmation and validation in Aim 3. In Aim 3, the Investigator will test the generalizability of their findings, explore the potential of methylation marks as biomarkers of disease in PBMCs and determine if change in methylation of these targets with AZA or folic acid affects key immune and regulatory pathways in a second set of CBD and BeS subjects. Throughout the Aims, the Investigator will use both fresh CD4+ T cells to directly assess disease relevance and Be-stimulated cultured CD4+ T cells (compared to unstimulated cultured T cells) to assess the impact of environmental exposure .

First Posted: 2015-11-13

Condition(s): Chronic Beryllium Disease

Intervention(s): Nothing

Status: COMPLETED

Enrollment (expected or actual): 148

Allocation:

Sponsor: National Jewish Health

Principal Investigator: Lisa Maier, MD

Completion Date (primary or actual): 2020-12-31

CT.gov Identifier: NCT02604693

Feasibility and Acceptability of the Cannabis Awareness and Prevention Toolkit

The Stanford Smart Talk Cannabis Awareness and Prevention Curriculum includes 5 lessons, each providing activities, online quiz games, and worksheets in addition to presentations, resources, and other materials aimed at addressing key factors associated with youth cannabis use, including changing adolescents' attitudes towards and misperceptions about cannabis; increasing their refusal skills to pulls of marketing and social media; reducing stress and depression which have been linked to cannabis initiation and use; improving coping skills; and decreasing intentions and actual use of all cannabis products. The aim of this study is to investigate the extent to which the curriculum changes students' intentions to use and actual use of cannabis.

First Posted: 2022-08-30

Condition(s): Cannabis Use

Intervention(s): Stanford Smart Talk Cannabis Awareness and Prevention curriculum

Status: COMPLETED

Enrollment (expected or actual): 658

Allocation: RANDOMIZED

Sponsor: Stanford University

Principal Investigator: Bonnie Halpern-Felsher, Marron and Mary Elizabeth Kendrick Professor in Pediatrics II

Completion Date (primary or actual): 2025-05-16

CT.gov Identifier: NCT05521321

Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome

The purpose of this study is to determine the tolerability and optimal dose of cannabidiol (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome (SWS) and drug resistant epilepsy.

First Posted: 2015-01-07

Condition(s): Sturge-Weber Syndrome

Intervention(s): Cannabidiol

Status: COMPLETED

Enrollment (expected or actual): 5

Allocation: NA

Sponsor: Anne Comi, MD

Principal Investigator: Anne Comi, MD, Principal Investigator, Director Sturge-Weber Center, Kennedy Krieger Institute, Professor Johns Hopkins University School of Medicine

Completion Date (primary or actual): 2021-04

CT.gov Identifier: NCT02332655

Effects of Polyphenol Supplementation and Exercise on Physical Performance in Older Adults

After approximately age 40 years, individuals experience a natural loss of muscle mass, strength, and physical function that is linked to higher risks of falls, disability, loss of independence, and mortality. These losses can also be a precursor to the development of frailty, which includes factors beyond impaired physical function such as cognitive impairment, psychological disorder, increased likelihood of hospitalization, need of long term-care, and mortality. Structured exercise-encompassing both resistance and aerobic training-is widely recognized as an effective lifestyle intervention for improving muscle health, cardiovascular capacity, and overall physical function in older adults. However, aging is accompanied by chronically elevated systemic inflammation, and although exercise remains highly beneficial, older adults exhibit a heightened inflammatory response to training and a diminished capacity for post-exercise recovery. Polyphenols, a group of naturally occurring bioactive compounds, have been shown to possess both anti-inflammatory and antioxidant benefits, positively impacting recovery and health. Polyphenol supplementation, particularly when paired with structured exercise, may elicit synergistic improvements in physical performance through combined effects on oxidative stress, inflammation, and muscle recovery, making polyphenols a compelling adjunct strategy for mitigating sarcopenia. In pursuit of refining strategies that support healthy aging and preserve functional capacity in older adults, this study aimed to determine the feasibility of implementing a 12-week resistance and aerobic exercise program combined with dietary supplementation in older adults. Participants will either consume a polyphenol blend or a placebo control of maltodextrin daily whilst undergoing 12 weeks of supervised resistance and aerobic exercise. Additionally, this study will test the hypothesis that polyphenol supplementation will augment the exercise-induced improvements in physical function and muscle health. Further, exploratory analyses of skeletal muscle biopsy and venous plasma samples will aid in elucidating the potential geroprotective effects of polyphenols at both cellular and molecular levels.

First Posted: 2026-02-27

Condition(s): Sarcopenia, Aging, Frailty

Intervention(s): Polyphenol Rich-Extract, Maltodextrin (Placebo), Resistance Band-Based & Aerobic Stationary Cycling Exercise

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Dr. Chris McGlory, PhD

Principal Investigator: Dr. Chris McGlory, PhD, Associate Professor, School of Kinesiology and Health Studies, Dept. Medicine, Queen's University

Completion Date (primary or actual): 2027-06-08

CT.gov Identifier: NCT07441343

A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal

This study is being done because there is a significant lack of data on the use of cannabis amongst cancer patients. The investigators believe that the collection of this data will help researchers and clinicians better understand the needs and the impact of cannabis use in this specific patient population.

First Posted: 2025-07-28

Condition(s): Cancer

Intervention(s):

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 45

Allocation:

Sponsor: Scot Remick

Principal Investigator: Scot Remick, Oncology Research and Education Principal

Completion Date (primary or actual): 2026-12-31

CT.gov Identifier: NCT07089225

Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis

Canada reports some of the highest rates of cannabis use in our youth and young adult populations, among all the developed countries. Recent Health Canada surveys report that 27% of 16-19-year-olds and 32% of 20-24-year-olds have used cannabis in the past 30 days, with 16-24-year-olds showing the highest rates of daily or near-daily use. Unfortunately, cannabis use has also been found to be a risk factor for the development of a psychotic disorder in emerging adults, and in those who develop psychosis and continue cannabis use, there is a significant effect on long term outcomes. This includes the severity of symptoms, risks of relapse (being hospitalized) and not reaching a level of functioning that would be expected. Lifetime experience with cannabis is greater than 80% in young adults with early phase psychosis (EPP; the first 5 years of a psychosis illness) with up to 30% of Canadian EPP patients meeting criteria for a diagnosis of cannabis use disorder (CUD) at entry to care. A recent Canadian population-based study found that cannabis use disorder associated to psychosis has risen from 3.7% pre-2018 to 10.3% at present. There has been a significant increase in Δ9-tetrahydrocannabinol (THC) levels in cannabis products available globally over the years, with popular cannabis products available start as high as 18% THC in Canada. However high potency cannabis carries a more significant risk for psychosis development, as well as higher risk for cannabis dependence and other severe mental health issues. A major gap in the research is a specific focus on cannabis potency on brain white matter (WM) in youth and young adults, and if there are any potential treatment strategies that could be used to influence any of these cannabis WM effects. To address this, a medication called metformin, that is already used in psychosis to help with side effects of antipsychotic medications, will be used as it has also shown promise to influence WM changes in other illnesses. This project is thus focused on naturalistic cannabis potency effects on WM in emerging adults in EPP (divided into three groups; those using high potency cannabis, low potency cannabis, and minimal cannabis use) and treating them with metformin for 6 months and assessing effects on neuroimaging, cognitive and clinical variables. The purpose of this pilot feasibility study is to inform the development/refinement of an intervention protocol, and not to test potential effects or mechanisms as the sample size will have insufficient power to perform an in-depth analysis. The results of this work will inform our research strategy development and assess feasibility of our novel methodological approach. Participants will: 1. Visit the clinic at baseline, 3 months (only Timeline Follow-Back Assessment administered), and 6 months post baseline to complete substance use and mental health questionnaires, and cognitive assessments 2. Complete an MRI scan at baseline and 6 months 3. Take Metformin every day for 6 months

First Posted: 2025-06-03

Condition(s): Psychosis, Cannabis Use

Intervention(s): Metformin

Status: RECRUITING

Enrollment (expected or actual): 24

Allocation: NA

Sponsor: Nova Scotia Health Authority

Principal Investigator: Phil Tibbo, Principal Investigator

Completion Date (primary or actual): 2026-12-01

CT.gov Identifier: NCT07001878

Cannabis Use Patterns Among Young Adults and Associations With Social and Health Outcomes.

The purpose of this study is to identify and characterize patterns of non-therapeutic cannabis consumption and their variation in time in regular/daily users aged 18-24 years using a multi-factor approach (frequency of use, product types, cannabinoid dosages) over a two-year period.

First Posted: 2025-07-14

Condition(s): Cannabis Use

Intervention(s): Mobile application

Status: RECRUITING

Enrollment (expected or actual): 350

Allocation:

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

Completion Date (primary or actual): 2027-08

CT.gov Identifier: NCT07063589

The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome

Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.

First Posted: 2021-11-10

Condition(s): Tourette Syndrome, Cannabis

Intervention(s): Medical Cannabis

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation:

Sponsor: Tel-Aviv Sourasky Medical Center

Principal Investigator:

Completion Date (primary or actual): 2021-03-31

CT.gov Identifier: NCT05115318

Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users

Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.

First Posted: 2014-02-12

Condition(s): Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users

Intervention(s): Cannabis (THC) in cigarettes of 30mg, 10mg and placebo

Status: COMPLETED

Enrollment (expected or actual): 37

Allocation: RANDOMIZED

Sponsor: Assistance Publique - Hôpitaux de Paris

Principal Investigator:

Completion Date (primary or actual): 2016-03

CT.gov Identifier: NCT02061020

Evaluation of the Pharmacokinetics of Prana P1 Capsules

This is a single dose clinical trial to assess the Pharmacokinetics of two (2) dosages; 10 mg and 20mg of THC: THCa of Prana P1 bionutrients in healthy volunteers.

First Posted: 2018-11-16

Condition(s): Healthy

Intervention(s): P1

Status: UNKNOWN

Enrollment (expected or actual): 13

Allocation: RANDOMIZED

Sponsor: The University of The West Indies

Principal Investigator: Shelly Rosemarie McFarlane, Coordinating Investigator

Completion Date (primary or actual): 2019-08-23

CT.gov Identifier: NCT03744091

Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study

Single subject repeated measures design of an open label administration of Cannabidiol (CBD) to 5 participants withdrawing from cannabis use in an inpatient setting. 300mg of CBD will be administered once on day 1, twice on days 2-5 and once on day 6. Participants will be discharged on day 7. CBD will be administered orally in capsules.

First Posted: 2014-03-11

Condition(s): Cannabis Use Disorder

Intervention(s): CBD

Status: UNKNOWN

Enrollment (expected or actual): 5

Allocation: NA

Sponsor: The University of New South Wales

Principal Investigator: Jan Copeland, Professor/Director NCPIC

Completion Date (primary or actual): 2014-12

CT.gov Identifier: NCT02083874

PET Tau - Neurodegenerative Disease Imaging

The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown to build up in the brains of patients with injury to brain cells. This study looks at neurodegenerative diseases such as frontotemporal degeneration (FTD).

First Posted: 2017-05-08

Condition(s): Neurodegenerative Disease

Intervention(s): 18F-AV-1451

Status: RECRUITING

Enrollment (expected or actual): 300

Allocation: NA

Sponsor: University of Pennsylvania

Principal Investigator:

Completion Date (primary or actual): 2030-09

CT.gov Identifier: NCT03143374

Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning

Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce vaginal pain during sexual intimacy among women post-gynaecological cancer treatment. Outcomes are also hoped to increase sexual functioning, well-being, sexual self-efficacy and quality of life. Research intention: If the combined mindful compassion and cannabis suppository intervention reduces vaginal pain and supports sexual and general well-being, then this research would be repeated on a larger scale targeting psychosexual services. A brief overview of the intervention: Mindfulness has been anecdotally discussed in reducing symptoms of vaginal pain and increasing overall well-being. A novel approach to pain management includes medical cannabis, which can be cannabidiol, tetrahydrocannabinol or both. Vaginal suppositories do not create a euphoric high in the same way as oral use, including inhalation. Quantitatively, randomisation will be based on whether participants use cannabis suppositories or not. This study does not randomise to cannabis groups owing to the legalities in the United Kingdom. Participants included eighty-three consenting participants. Of these, forty-one were using cannabis suppositories. The intervention was delivered for one month, and the follow-up was at twelve weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.

First Posted: 2024-09-23

Condition(s): Sexual Pain Disorders

Intervention(s): Mindful- compassion, Mindful-compassion and cannabis suppositories

Status: COMPLETED

Enrollment (expected or actual): 83

Allocation: RANDOMIZED

Sponsor: London Metropolitan University

Principal Investigator: Samantha Banbury, Principal Investigator

Completion Date (primary or actual): 2024-04-04

CT.gov Identifier: NCT06607835

Clinical Study to Evaluate the Effects of Oral Delta-9-tetrahydrocannabinol (Δ9-THC) With and Without Alcohol on Perception and Driving Performance in Healthy Adults

With the increasing prevalence and use of cannabis products by the public, there exists a need to better understand the safety impact of cannabis use, particularly when it comes to subjective perceptions of drug effect and driving impairment. This study aims to evaluate the dose-dependent effects of oral Δ9-THC alone and in combination with alcohol (0.08% BAC \[Blood Alcohol Concentration\]) on driving performance and subjective feeling in healthy adults. The results of this study will address current knowledge gaps on the effects of oral Δ9-THC on driving impairment across a clinically relevant dose range.

First Posted: 2025-09-16

Condition(s): Cannabis, Drug Effects, Driving Performance

Intervention(s): 5 mg Dronabinol (Marinol®) + Placebo Beverage, 10 mg Dronabinol (Marinol®) + Placebo Beverage, 5 mg Dronabinol (Marinol®) + Alcohol Beverage, 10 mg Dronabinol (Marinol®) + Alcohol Beverage, Placebo Capsule + Alcohol Beverage, Placebo Capsule + Placebo Beverage

Status: COMPLETED

Enrollment (expected or actual): 48

Allocation: RANDOMIZED

Sponsor: Food and Drug Administration (FDA)

Principal Investigator:

Completion Date (primary or actual): 2026-06-19

CT.gov Identifier: NCT07176208

The Cost Effectiveness of Endoscopic Ultrasound ( EUS ) Based Strategy in Diagnosis of Common Bile Duct Stones

Multiple reports in the literature showed the efficacy of EUS comparable to ERCP in the diagnosis of common bile duct ( CBD ) stone. The EUS-based strategy has provided the cost effectiveness in diagnosis of CBD stone in defined patient risk groups was showed in previous studies. The aim of our study was to assess the cost effectiveness of EUS based strategy versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risks for CBD stones in a real working situation in a developing country.

First Posted: 2015-01-29

Condition(s): Common Bile Duct Calculi

Intervention(s): High risk group, Intermediate risk group

Status: COMPLETED

Enrollment (expected or actual): 141

Allocation:

Sponsor: Prince of Songkla University

Principal Investigator: Nisa Netinatsunton, NKC Institute of Gastroenterology and Hepatology

Completion Date (primary or actual): 2014-12

CT.gov Identifier: NCT02349568

Trial of Cannabis for Essential Tremor

This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.

First Posted: 2019-01-16

Condition(s): Essential Tremor

Intervention(s): CBD/THC, Placebo oral capsule

Status: COMPLETED

Enrollment (expected or actual): 7

Allocation: RANDOMIZED

Sponsor: University of California, San Diego

Principal Investigator: Fatta B Nahab, Associate Professor of Neurosciences

Completion Date (primary or actual): 2020-11-30

CT.gov Identifier: NCT03805750

Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1

This study will assess the effectiveness of a combination of buspirone and motivational interviewing therapy in the treatment of marijuana dependence.

First Posted: 2005-09-08

Condition(s): Marijuana Abuse, Mood Disorders

Intervention(s): Buspirone

Status: COMPLETED

Enrollment (expected or actual): 81

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator:

Completion Date (primary or actual): 2007-12

CT.gov Identifier: NCT00149617

Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy

This pilot study will evaluate the feasibility and safety of using 1:1 tetrahydrocannabinol (THC):Cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based Opioid Agonist Therapy (OAT) for individuals with opioid use disorder (OUD) in a community setting.

First Posted: 2023-08-14

Condition(s): Opioid Use Disorder, Methadone, Cannabis, Fentanyl

Intervention(s): Aurora 1:1 Drops (Indica), Placebo

Status: RECRUITING

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: BC Centre on Substance Use

Principal Investigator: M. Eugenia Socias, Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU

Completion Date (primary or actual): 2027-03

CT.gov Identifier: NCT05985850

Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

Investigators aim to determine Epidiolex's promise as a pharmacotherapy for cannabis use disorder. Investigators hypothesize that Epidiolex, when added to medical management, will result in greater reductions in marijuana use compared to placebo as measured by the 2 primary outcome measures: 1) quantitative THC levels and 2) self-report by Timeline Follow Back. Secondary outcome measures will include treatment retention, patient satisfaction, cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, , compliance, and cigarette use.

First Posted: 2017-04-06

Condition(s): Cannabis Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: RANDOMIZED

Sponsor: Mclean Hospital

Principal Investigator: Kevin P. Hill, MD, MHS, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2017-08-30

CT.gov Identifier: NCT03102918

Long Term Safety Follow up of Haematopoietic Stem Cell Gene Therapy for the Wiskott Aldrich Syndrome

An open follow up study of patients enrolled in the Phase 1/2 clinical trial of haematopoietic stem cell gene therapy for the Wiskott-Aldrich Syndrome and treated with autologous CD34+ cells transduced with the w1.6\_hWASP\_WPRE (VSVg) lentiviral vector.

First Posted: 2015-01-07

Condition(s): Wiskott-Aldrich Syndrome

Intervention(s): Autologous CD34+ cells transduced with WASP lentiviral vector

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: Genethon

Principal Investigator:

Completion Date (primary or actual): 2032-10

CT.gov Identifier: NCT02333760

Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults

The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are: Will a marijuana-based drug help anxiety in autistic adults? Anxiety can make socializing and working more difficult for people. Researchers will compare a marijuana based drug (that is mostly CBD with a small amount of THC) to a placebo (a look-alike substance that contains no drug) to see if the drug makes symptoms of anxiety better. Participants will take the drug (or a placebo) every day for 8 weeks and keep a diary to record the time they took the drug, and their feelings each day. The drug is taken orally in drops once or twice a day. The study staff will speak to the participants weekly either over the phone or in the clinic. Clinic visits once every 2 weeks for checkups and tests. The researchers will make sure participants are healthy and see if there are any changes in anxiety.

First Posted: 2024-07-29

Condition(s): Autism Spectrum Disorder, Anxiety

Intervention(s): MB-IMP, Placebo

Status: RECRUITING

Enrollment (expected or actual): 108

Allocation: RANDOMIZED

Sponsor: Southwest Autism Research & Resource Center

Principal Investigator:

Completion Date (primary or actual): 2027-09-30

CT.gov Identifier: NCT06526208

A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain

The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.

First Posted: 2008-07-11

Condition(s): Pain, Peripheral Neuropathy

Intervention(s): Sativex®, Placebo

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2007-07

CT.gov Identifier: NCT00713817

Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers

Ultraviolet light A (UVA) causes oxidization of guanine to mutagenic 8-Oxoguanine (8-OxoG) and the most frequent and best characterized mutation in mitochondrial DNA (mtDNA), a deletion of 4,977 base pairs, called the "common deletion", a marker of photoaging.

First Posted: 2022-03-15

Condition(s): Photoaging

Intervention(s): In a double-blinded fashion, 250 mg CANNAXR cream, Topical VEHICLE cream

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: MINO Labs, LLC

Principal Investigator:

Completion Date (primary or actual): 2023-05-15

CT.gov Identifier: NCT05279495

4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2

The goal of this study is to identify the most reliable methods of analysis for tracking CBD, PSP, and o/vPSP over time. The results from this study may be used in the future to calculate statistical power for clinical drug trials. The study will also provide information about the relative value of novel imaging techniques for diagnosis, as well as the value of imaging techniques versus testing of blood, urine, and cerebrospinal fluid (CSF) 'biomarkers'.

First Posted: 2016-11-17

Condition(s): Corticobasal Degeneration (CBD), Corticobasal Syndrome (CBS), Cortical-basal Ganglionic Degeneration (CBGD), Progressive Supranuclear Palsy (PSP), Nonfluent Variant Primary Progressive Aphasia (nfvPPA), Oligosymptomatic/Variant Progressive Supranuclear Palsy (o/vPSP)

Intervention(s): Observational Study

Status: COMPLETED

Enrollment (expected or actual): 293

Allocation:

Sponsor: University of California, San Francisco

Principal Investigator:

Completion Date (primary or actual): 2024-02-28

CT.gov Identifier: NCT02966145

Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury

We aim to determine the efficacy of a controlled short-term trial of CBD ingestion for reducing symptomatic response and facilitating recovery following induced muscle injury. We will assess, in serial fashion, symptomatic response, functional limitations and recovery of the quadriceps muscle following induced injury in which CBD oil (or placebo) will be delivered using a sublingual route of administration during a 15-day pre-injury consumption and post-injury recovery phase. A double-blind, randomized, two-arm study design will be used and participants will be randomly assigned to either an active dose (n=15) or vehicle control group (n=15). The clinical outcomes include measures of muscular pain and disability along with measures of pain-related fear and anxiety.

First Posted: 2020-10-14

Condition(s): Muscle Injury, Recovery, Pain Relief

Intervention(s): Active CBD, Vehicle Control (Placebo)

Status: COMPLETED

Enrollment (expected or actual): 34

Allocation: RANDOMIZED

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): 2024-03-21

CT.gov Identifier: NCT04586712

Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients

This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD) vs.semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson's disease (PD) who suffer motor fluctuations.The objective of this study is to assess the plasma pharmacokinetics (PK) of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD. For purposes of this study continuous intra-oral administration of LD/CD is defined as oral administration of LD/CD at 5-10 minute intervals. Secondary objectives are to assess the safety and tolerability of continuous intra-oral administration of LD/CD and the effect on PD motor function of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD.

First Posted: 2016-05-05

Condition(s): Parkinson Disease

Intervention(s): Standard LD/CD, Semi continuous intra-oral administration of LD/CD

Status: COMPLETED

Enrollment (expected or actual): 18

Allocation: NON_RANDOMIZED

Sponsor: IRCCS San Raffaele Roma

Principal Investigator:

Completion Date (primary or actual): 2015-10

CT.gov Identifier: NCT02763137

Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression

The prevalence of major depressive disorder (MDD) is \~5.0%, and rates of co-occurring SUDs in these patients approach 40-50%. Specifically, rates of co-morbid cannabis use disorder (CUD) in patients with MDD are elevated 2-3 fold compared to 2.9% in the general population, and is associated with poorer treatment outcomes and impaired cognitive and psychosocial functioning in comparison to MDD patients without CUD. Most studies of cannabis use in MDD are cross-sectional in design, and therefore causal relationships are unclear. This study investigates the effects of cannabis abstinence over a 28-day period in patients with MDD with co-occurring CUD using a randomized controlled design, namely contingent reinforcement.

First Posted: 2021-06-23

Condition(s): Cannabis Use, Major Depressive Disorder, Cognitive Impairment

Intervention(s): Contingency Reinforcement, Non-Contingency Reinforcement

Status: RECRUITING

Enrollment (expected or actual): 52

Allocation: RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2027-08-31

CT.gov Identifier: NCT04935619

The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis extract use for ASD is promising but still limited. The aim of this study is to investigate if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities of autism, including sleep and eating problems, anxiety and violence. The main objectives of the study are: 1) to characterize the effect of treatment with cannabis oil on comorbid symptoms of ASD; 2) to compare safety and efficacy of different cannabis products with identical CBD:THC ratio; 3) to investigate the effect of treatment on cognitive and adaptive behavior; and 4) to measure THC and CBD and metabolites levels in the blood of the patients. In this study, patients diagnosed with ASD will be treated with cannabidiol-rich cannabis oil (CBD:THC ratio of 20:1). The researchers will collect parental reports on ASD comorbid symptoms before and bi-weekly during 6 months of the study period. Blood tests will be performed before and after three months of treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and metabolites. Cognitive evaluation will be done before and after six months of treatment. Electroencephalogram (EEG) to exclude epilepsy will be performed before and after six months of treatment.

First Posted: 2022-01-28

Condition(s): Autism Spectrum Disorder

Intervention(s): Cannabis oil

Status: COMPLETED

Enrollment (expected or actual): 128

Allocation: RANDOMIZED

Sponsor: Assaf-Harofeh Medical Center

Principal Investigator:

Completion Date (primary or actual): 2023-12-31

CT.gov Identifier: NCT05212493

An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)

This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses \[123I\]-IBZM and dynamic SPECT imaging to determine the amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.

First Posted: 2005-09-20

Condition(s): Parkinson's Disease

Intervention(s): carbidopa/l-dopa, carbidopa/l-dopa/entacapone, Stalevo, [123I]-IBZM imaging

Status: COMPLETED

Enrollment (expected or actual): 3

Allocation: RANDOMIZED

Sponsor: Molecular NeuroImaging

Principal Investigator:

Completion Date (primary or actual): 2004-09

CT.gov Identifier: NCT00200447

THC + CBD and Memory Study

Memory deficits are one of the most consistently observed cognitive effects of marijuana use. There is evidence that some decrements attributable to the primary psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), may be attenuated by cannabidiol (CBD). This study will help us learn more about the relationship between THC and CBD consumption with memory processes. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure the neurocognitive and behavioral impacts of THC and CBD use.

First Posted: 2021-04-22

Condition(s): Marijuana Use, Cannabis Use, Cannabis Intoxication

Intervention(s): High THC/No CBD Marihuana, High THC/High CBD Marihuana, No THC/No CBD Marihuana

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 9

Allocation: RANDOMIZED

Sponsor: Hartford Hospital

Principal Investigator: Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Completion Date (primary or actual): 2026-12-30

CT.gov Identifier: NCT04855526

The Teen Marijuana Check-Up

This behavioral research is an efficacy trial evaluating an intervention called "The Teen Marijuana Check-Up" with non-treatment seeking adolescent marijuana users.

First Posted: 2006-07-10

Condition(s): Cannabis Abuse, Cannabis Dependence

Intervention(s): Motivational enhancement therapy, Marijuana education

Status: COMPLETED

Enrollment (expected or actual): 310

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator:

Completion Date (primary or actual): 2008-06

CT.gov Identifier: NCT00350285

Virtual Environment With Biofeedback to Promote Awareness of Relapse Risk Among Chemically Dependent Individuals

Anxiety is one of the major influences on relapse and substance abuse treatment dropout. Chemically dependent individuals need to be aware of their emotional state in situations that jeopardise their treatment. The current therapeutic resources still subjective and with limited treatment success. This research presents a developed virtual environment (VE) simultaneously connected to a physiological signals device acquisition that allows, through a biofeedback, the chemically dependents consciousness on their vulnerability front different situations of 'risk', without a direct assessment of the therapist. Developed in 3ds Max® software, the VE is composed of scenarios and objects that are in the habit of the chemically dependent individual's daily life. The interaction with the environment is accomplished using a Human-Computer Interface (HCI) that converts incoming physiological signals indicating anxiety state into commands that change the scenes. Anxiety is characterized by the average variability from both heart and respiratory rate of 30 volunteers undergoing stress environment situations. To evaluate the effectiveness of the VE as a biofeedback of chemically dependent's vulnerability front situations of risk, a total of 50 volunteers who were drug users, monitored by 10 therapists, were enrolled. Prior VE, the results demonstrated a poor correlation between the therapists' predictions and those of the chemically dependent individuals. After exposure to the VE, there was a significant increase of 73% in awareness of the risks of relapse by the chemically dependent individuals, confirming the hypothesis that the VE coupled to the biofeedback device may assist the therapist with treatment.

First Posted: 2015-08-31

Condition(s): Anxiety

Intervention(s): Heart and respiratory rate and VE, Heart and respiratory rate and video

Status: COMPLETED

Enrollment (expected or actual): 80

Allocation: NON_RANDOMIZED

Sponsor: University of Mogi das Cruzes

Principal Investigator: Annie France Frère Slaets, PhD

Completion Date (primary or actual): 2008-05

CT.gov Identifier: NCT02535858

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil). After the run-in period, doses of CBD will be incresed during the first six weeks of the study. At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three month. Each patient will serve as his/her own control.

First Posted: 2020-06-19

Condition(s): Chronic Spontaneous Urticaria

Intervention(s): CBD

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation: NA

Sponsor: Stero Biotechs Ltd.

Principal Investigator:

Completion Date (primary or actual): 2021-07-30

CT.gov Identifier: NCT04439955

Dual Diagnosis (Psychosis and Cannabismisuse): Comparison of Specialized Treatment Versus Unspecified Treatment

Intention of the study is to examine, if the symptomatology of dual diagnosis patients is less severe after a special indication training for reduction of cannabis consumption in comparison to unspecified trainings. Point of interest is psychopathology and consumerism.

First Posted: 2008-10-31

Condition(s): Psychotic Disorders, Marijuana Abuse, Intervention

Intervention(s): Cannabis-Consumption-Reduction-Training, Social competence Training

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: University of Konstanz

Principal Investigator:

Completion Date (primary or actual): 2010-01

CT.gov Identifier: NCT00783185

Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

First Posted: 2017-08-18

Condition(s): Cannabis Use

Intervention(s): Lorcaserin, Placebo, Marijuana

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Margaret Haney, Professor of Neurobiology (in Psychiatry) at CUMC

Completion Date (primary or actual): 2021-12-31

CT.gov Identifier: NCT03253926

GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes

This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in combination in patients with Type 2 diabetes. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight, liver fat content and other metabolic parameters compared with a placebo medication.

First Posted: 2010-10-08

Condition(s): Dyslipidemias, Diabetes Mellitus, Type 2

Intervention(s): GWP42003, GWP42003, GWP42004, Placebo

Status: COMPLETED

Enrollment (expected or actual): 62

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2012-09

CT.gov Identifier: NCT01217112

Effects of Inhaled Cannabis on Driving Performance

The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol. This project will involve the development a of a protocol and driving environment that is sensitive to the effects of cannabis on driving performance by building on prior driving situations used previously for testing the effects of alcohol on driving.

First Posted: 2012-06-15

Condition(s): Alcohol Drinking, Cannabis

Intervention(s): Alcohol(oral) and placebo, Cannabis(THC)(Inhaled) and Placebo

Status: COMPLETED

Enrollment (expected or actual): 98

Allocation: RANDOMIZED

Sponsor: Gary R Gaffney

Principal Investigator: Gary R Gaffney, Associate Professor, College of Medicine

Completion Date (primary or actual): 2014-03

CT.gov Identifier: NCT01620177

Clinical Trial on Pharmacokinetic and Tolerability of AP701

This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

First Posted: 2021-01-14

Condition(s): Pharmacokinetic, Tolerability, Safety

Intervention(s): AP701

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation: NA

Sponsor: CannaXan GmbH

Principal Investigator:

Completion Date (primary or actual): 2021-03-07

CT.gov Identifier: NCT04708795

Role of CBD in Improving Alexithymia

Given the treatments that are available today for HIV disease, people living with HIV (PLWH) can generally expect good medical outcomes. However, HIV is still a chronic disease and there are remaining barriers to achieving ideal health status and quality of life. One barrier may be a condition that is common among PLWH, called alexithymia, which can make it difficult for a person to name and describe the emotions that they are feeling. As a result, it is difficult to resolve negative emotional states, which can then lead to worse outcomes over time due to ongoing stress and related problems such as inflammation. In this study the investigators will try to find out whether taking cannabidiol (CBD) helps PLWH who have alexithymia to resolve those negative emotional states, which may then reduce inflammation in the body as a result. CBD may work by enhancing the body's own chemical messengers that can help to regulate emotions and encourage emotional benefits. The investigators will compare a group of people who take CBD for 4 weeks to those who take a placebo, which is a substance that will closely resemble the CBD but will not contain any active drug. Study participants and the researchers who are working directly with the participants will not be able to tell which is the CBD and which is the placebo. The investigators will evaluate participants before and after the 4-week study period. They will also collect samples, such as blood, so that we can measure inflammation. The investigators will compare the two groups to see if those who took CBD have lower alexithymia and lower inflammation compared to those who took the placebo. The potential benefit of this study is that CBD may be an effective treatment for alexithymia in PLWH, which may then improve both their emotional and physical health outcomes. This can help to address a remaining barrier to good medical outcomes for PLWH.

First Posted: 2023-04-27

Condition(s): Alexithymia, HIV

Intervention(s): Purysis CBD, Placebo

Status: TERMINATED

Enrollment (expected or actual): 6

Allocation: RANDOMIZED

Sponsor: University of California, San Diego

Principal Investigator: Erin Morgan, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2025-08-31

CT.gov Identifier: NCT05832281

Molecular and Clinical Studies of Primary Immunodeficiency Diseases

This study will try to identify mutations in the genes responsible for primary immunodeficiency disorders (inherited diseases of the immune system) and evaluate the course of these diseases in patients over time to learn more about the medical problems they cause. The immune system is composed of various cells (e.g., T and B cells and phagocytes) and other substances (complement system) that protect the body from infections and cancer. Abnormalities in the gene(s) responsible for the function of these components can lead to serious infections and other immune problems. Patients with Wiskott-Aldrich syndrome, adenosine deaminase (ADA) deficiency. Participants will undergo a medical and family history, physical examination, and additional procedures and tests that may include the following: 1. Blood tests for: routine laboratory studies (i.e. cell counts, enzyme levels, electrolytes, etc.); HIV testing; immune response to various substances; genetic testing; and establishment of cell lines to maintain a supply of cells for continued study 2. Urine and saliva tests for biochemical studies 3. Skin tests to assess response to antigens such as the viruses and bacteria responsible for tetanus, candida, tuberculosis, diphtheria, chicken pox, and other diseases. 4. Skin and lymph node biopsies for tissue and DNA studies 5. Chest X-ray, CT scans, or both to look for cancer or various infections. 6. Pulmonary function test to assess lung capacity and a breath test to test for H. pylori infection. 7. Dental, skin and eye examinations. 8. Treatment with intravenous immunoglobulins or antibodies to prevent infections. 9. Apheresis for collecting white blood cells to study cell function. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle or through a second needle placed in the other arm. 10. Bone marrow sampling to study the disease. A small amount of marrow from the hipbone is drawn (aspirated) through a needle. The procedure can be done under local anesthesia or light sedation. 11. Placental and umbilical cord blood studies, if cord blood is available, to study stem cells (cells that form blood cells). Information gained from this study may provide a better understanding of primary immunodeficiencies, leading to better diagnosis and treatment. In addition, study participants may receive medical and genetic counseling and may be found eligible for other NIH studies on these diseases.

First Posted: 2000-10-02

Condition(s): Wiskott- Aldrich Syndrome, ADA Deficient SCID

Intervention(s):

Status: UNKNOWN

Enrollment (expected or actual): 266

Allocation:

Sponsor: National Human Genome Research Institute (NHGRI)

Principal Investigator:

Completion Date (primary or actual):

CT.gov Identifier: NCT00006319

Post-transplant Cyclophosphamide in Wiskott-Aldrich Syndrome

A protocol named as "CIP-2015" for patients with Wiskott-Aldrich Syndrome may reduce the rate of GvHD. The details of the protocal followed with: 1. Conditioning regimen Busulfan 16 mg/kg in total, Fludarabine 160 mg/m2 in total. 2. GvHD Prophylaxis: Rabbit antihuman thymocyte globulin 7.5 mg/kg post-transplant cyclophosphamide (CY) (50 mg/kg.d on days +3 and +4) Cyclosporine or tacrolimus, mycophenolate mofetil, on days +5

First Posted: 2017-06-26

Condition(s): Wiskott-Aldrich Syndrome

Intervention(s): cyclophosphamide

Status: UNKNOWN

Enrollment (expected or actual): 5

Allocation:

Sponsor: Capital Research Institute of Pediatrics

Principal Investigator: Yan Yue, MD,PhD

Completion Date (primary or actual): 2020-07-10

CT.gov Identifier: NCT03198195

Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence

The proposed study will look at cocaine dependent individuals and will consist of three consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy will be administered; 2) the 15-21 day inpatient phase (during which participants will start study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE may reverse baseline brain deficits and if this change is associated with clinical improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence from cocaine over a 12-week trial in combination with behavioral treatment with voucher incentives.

First Posted: 2011-11-09

Condition(s): Cocaine Dependence

Intervention(s): levodopa carbidopa and entacapone (LCE), Placebo

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Adam Bisaga, Research Psychiatrist

Completion Date (primary or actual): 2015-12

CT.gov Identifier: NCT01468012

Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)

This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.

First Posted: 2013-01-17

Condition(s): Parkinson's Disease, Motor Symptoms, Akinesia, Hypomobility, Delayed Levodopa Onset

Intervention(s): APOKYN, L-dopa, Trimethobenzamide

Status: COMPLETED

Enrollment (expected or actual): 127

Allocation: NA

Sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2014-04

CT.gov Identifier: NCT01770145

Combined Pharmacotherapy for Cannabis Dependency

The purpose of this study is to see if Lofexidine in combination with Marinol is superior to placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use.

First Posted: 2009-11-25

Condition(s): Cannabis Dependence, Marijuana Dependence

Intervention(s): Dronabinol, Placebo, Lofexidine

Status: COMPLETED

Enrollment (expected or actual): 156

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Frances R Levin, Director of Substance Use Disorder

Completion Date (primary or actual): 2014-09

CT.gov Identifier: NCT01020019

Effect of Baclofen on Marijuana Withdrawal and Relapse

The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.

First Posted: 2006-09-08

Condition(s): Marijuana Dependence

Intervention(s): Baclofen, Marijuana, Placebo

Status: COMPLETED

Enrollment (expected or actual): 13

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator:

Completion Date (primary or actual): 2010-01

CT.gov Identifier: NCT00373295

Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

It is known, that a so called "pain memory" usually evolves in chronic pain syndromes which both aggravates the disorder and modifies the patients pain perception. Thus, the principal object of pain therapy is to "delete" this dysfunctional pain memory. The combination of medication, physiotherapy and psychological therapy seems to be the most effective treatment. This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on the effectiveness of behavioral therapy. It is hypothesized that the combination of behavioral therapy and Dronabinol will be most effective in deleting the pain memory.

First Posted: 2005-09-15

Condition(s): Fibromyalgia, Back Pain

Intervention(s): Operant behavioral treatment; Drug: THC

Status: COMPLETED

Enrollment (expected or actual): 240

Allocation: RANDOMIZED

Sponsor: Heidelberg University

Principal Investigator:

Completion Date (primary or actual): 2009-05

CT.gov Identifier: NCT00176163

Effect of Preoperative Sleep Disturbance on Postoperative Pain and Recovery

The study subjects consisted of patients who underwent elective total knee arthroplasty (TKA) at Gansu Provincial Hospital of TCM from November 2023 to January 2024. The Pittsburgh Sleep Quality Index Questionnaire (PSQI) was used to assess the overall sleep status of patients over the past month. All patients were divided into normal sleep group (PSQI ≤ 5) and poor sleep group (PSQI score \> 5). Postoperative pain was assessed using a numeric rating scale (NRS), and hydromorphone (HM) consumption, number of rescue analgesia, and quality of recovery QoR-15 scores were recorded 24 hours after surgery. Spearman correlation analysis was used to detect the correlation between each index and preoperative PSQI score. A logistic regression model was used to analyze the relationship between PSQI score, serum BDNF and CB1R concentrations, and the occurrence of moderate to severe pain 24 hours after surgery. Generalized linear regression models combined with restricted cubic spline models were used to analyze the relationship and dose-response relationship between PSQI, BDNF, and CB1R and QoR-15 score and HM consumption at 24 hours after surgery after adjusting for confounders. Serum BDNF and CB1R mediation effects were analyzed by Process plug-in.

First Posted: 2025-02-07

Condition(s): Total Knee Arthroplasty (TKA)

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 200

Allocation:

Sponsor: Gansu Provincial Hospital

Principal Investigator: Jie Zhang, Resident physician

Completion Date (primary or actual): 2024-01-31

CT.gov Identifier: NCT06815744

Treatment of Drug Resistant Epilepsy

The main goal of this study is to provide treatment with cannabidiol (CBD) to children with drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol. As the controlled therapeutic use of CBD in children is novel, the primary objective of this study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy in children that have exhausted the majority of FDA approved antiepileptic drug treatment options.

First Posted: 2015-06-03

Condition(s): Epilepsy

Intervention(s): cannabidiol, Blood Test

Status: NO_LONGER_AVAILABLE

Enrollment (expected or actual):

Allocation:

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual):

CT.gov Identifier: NCT02461706

Safety and Pharmacokinetics of Smoked Cannabis in Healthy Patients

No actual human data for pharmacokinetics, metabolism, safety, pharmacodynamics, nor efficacy parameters are available for inhaled medical cannabis. This study was designed to investigate the innocuity and tolerability levels as well as the pharmacokinetic profile of this combination when smoked/inhaled as intended in clinical therapeutic use (i.e. patients with neuropathic pain). Consecutive dosing (over a period of 7 days) should allow to test the tolerability of chronic administration. In addition, the impact of the THC/cannabidiol pharmacological activity on the cognition activity, cognitive test will be performed before and throughout the treatment and compared to the plasma levels of THC/cannabidiol following single and multiple dosing.

First Posted: 2020-03-19

Condition(s): Healthy Volunteers

Intervention(s): PPP001, Placebo

Status: COMPLETED

Enrollment (expected or actual): 48

Allocation: RANDOMIZED

Sponsor: Tetra Bio-Pharma

Principal Investigator:

Completion Date (primary or actual): 2017-11-16

CT.gov Identifier: NCT04314804

A Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy

To evaluate the safety, tolerability and efficacy of oral administration of PTL101 (cannabidiol) for the treatment for pediatric intractable epilepsy. Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow up.

First Posted: 2016-12-08

Condition(s): Epilepsy Intractable

Intervention(s): PLT101

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: NA

Sponsor: PhytoTech Therapeutics, Ltd.

Principal Investigator:

Completion Date (primary or actual): 2018-06-28

CT.gov Identifier: NCT02987114

eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

This is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off.

First Posted: 2021-08-04

Condition(s): Parkinson Disease

Intervention(s): Opicapone, L-DOPA/DDCI

Status: COMPLETED

Enrollment (expected or actual): 106

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2023-04-04

CT.gov Identifier: NCT04990284

Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper

The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects.

First Posted: 2006-09-08

Condition(s): Marijuana Dependence

Intervention(s): Marijuana blunt, marijuana cigarette

Status: COMPLETED

Enrollment (expected or actual): 35

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator:

Completion Date (primary or actual): 2008-08

CT.gov Identifier: NCT00374127

Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence

Cocaine dependence is a major public health problem and the development of a treatment for this disorder is a priority. To date, treatment interventions based on positive incentive principles have shown the strongest effects for improving substance use outcomes. One such example is contingency management (CM) interventions in which nondrug rewards are used to compete with cocaine. Recent evidence suggests that certain medications improve response to CM interventions, particularly agents that target dopamine reward systems in the brain. A promising dopamine-enhancing medication is levodopa. The study team has observed the strongest effects of levodopa when the medication is administered in the context of CM therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is designed to further evaluate this promising treatment approach. Cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. CM will be behavioral therapy platform for both treatment groups. The study will test the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing cocaine use. This study is expected to validate the usefulness of a new behavioral-pharmacological treatment approach for cocaine dependence.

First Posted: 2008-07-11

Condition(s): Cocaine Dependence

Intervention(s): levodopa, Placebo, Cognitive Behavioral Therapy, Contingency Management

Status: COMPLETED

Enrollment (expected or actual): 85

Allocation: RANDOMIZED

Sponsor: The University of Texas Health Science Center, Houston

Principal Investigator: Joy Schmitz, Professor - Psychiatry, Behavioral Sciences

Completion Date (primary or actual): 2011-12

CT.gov Identifier: NCT00713583

Nigella Sativa Oil for Eczematous Otitis Externa

Eczematous otitis externa is a common inflammatory condition of the external auditory canal characterized by itching, discomfort, discharge, and pain. Topical corticosteroids are widely used for treatment; however, alternative therapies with fewer side effects are of increasing interest. This study aims to compare the efficacy of Nigella sativa (black seed) oil and mometasone furoate ear drops in the treatment of eczematous otitis externa. Nigella sativa is a natural product with known anti-inflammatory and antimicrobial properties. In this randomized, controlled clinical trial, adult patients with eczematous otitis externa will be assigned to receive either Nigella sativa oil or mometasone furoate ear drops for 10 days. Clinical symptoms and inflammatory findings will be evaluated at baseline and after treatment. The objective of this study is to determine whether Nigella sativa oil is an effective and safe alternative to topical corticosteroid therapy.

First Posted: 2026-04-13

Condition(s): Eczema/Atopic Dermatitis, Otitis Externa

Intervention(s): Mometasone Furoate (MF), Nigella sativa oil

Status: RECRUITING

Enrollment (expected or actual): 85

Allocation: RANDOMIZED

Sponsor: Bezmialem Vakif University

Principal Investigator: Nazan Degirmenci, Assoc. Prof.

Completion Date (primary or actual): 2026-07

CT.gov Identifier: NCT07525505

A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics

This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and pharmacokinetics profile.

First Posted: 2015-02-10

Condition(s): Functional Constipation, Gastrointestinal Disorders

Intervention(s): MZRW

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: RANDOMIZED

Sponsor: Hong Kong Baptist University

Principal Investigator: ZhaoXiang Bian, Chair Professor, Director of Clinical Division,

Completion Date (primary or actual): 2015-08

CT.gov Identifier: NCT02359396

Gene Therapy for Wiskott-Aldrich Syndrome (WAS)

This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell genetherapy for the Wiskott-Aldrich Syndrome.

First Posted: 2011-05-04

Condition(s): Wiskott-Aldrich Syndrome

Intervention(s): Autologous CD34 positive cells transduced with a lentiviral vector containing human WAS gene

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: NA

Sponsor: Genethon

Principal Investigator:

Completion Date (primary or actual): 2019-11-13

CT.gov Identifier: NCT01347242

Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.

First Posted: 2019-05-03

Condition(s): Stone - Biliary

Intervention(s): Saline irrigation

Status: COMPLETED

Enrollment (expected or actual): 180

Allocation: RANDOMIZED

Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Principal Investigator: Wenbo Meng, M.D., Ph. D, Direct of surgery

Completion Date (primary or actual): 2022-12-31

CT.gov Identifier: NCT03937037

Gastrostomy-Biliary Diversion: Innovative Management for Bile Canalicular Transport Disorders

Progressive familial intrahepatic cholestasis (PFIC) is a group of disorders that can present early in life with cholestasis and intractable pruritus. Their treatment poses a great challenge, with medical treatment is not successful in many cases. Moreover, the available non-transplant surgeries carry many side effects and different degrees of efficacy. Partial external biliary diversion, internal biliary diversion, and ileal exclusion still lack widespread experience with many side effects. Nasobiliary stent placement has little tolerability, especially in younger age. Gastrobiliary tube is a novel modality for external biliary diversion in such patients.

First Posted: 2019-08-28

Condition(s): Progressive Familial Intrahepatic Cholestasis

Intervention(s): Gastostomy-biliary tube, External biliary diversion, internal biliary diversion and nasobiliary tube

Status: UNKNOWN

Enrollment (expected or actual): 20

Allocation: NON_RANDOMIZED

Sponsor: National Liver Institute, Egypt

Principal Investigator:

Completion Date (primary or actual): 2021-04-01

CT.gov Identifier: NCT04071197

nVNS, CBD, and SoC for Persistent Post-Traumatic Headache

Do cannabidiol (CBD) or vagus nerve stimulation reduce the frequency of persistent post-traumatic headache more than traditional oral headache medications?

First Posted: 2026-06-03

Condition(s): Persistent Post Traumatic Headache

Intervention(s): Non-Invasive Vagus Nerve Stimulation, Cannabidiol, Standard of Care

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: American Society of Pain and Neuroscience, Inc.

Principal Investigator:

Completion Date (primary or actual): 2028-07-01

CT.gov Identifier: NCT07624279

1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study)

Growing evidence suggests that dopamine contributes to key cognitive, emotional, and motor functions across the lifespan. In Late-Life Depression (LLD), dysfunction in these areas is common, predicts poor outcomes, and manifests as difficulties in motivation and effort along with cognitive and gait impairment. While studies of dopamine function in early and midlife depression primarily focus on individuals' ability to feel pleasure and respond to rewards, they often exclude the cognitive and physical function domains relevant for older adults despite a recognized decline in dopamine function with normal aging. The objectives of this collaborative R01 proposal between Columbia University/New York State Psychiatric Institute and Vanderbilt University Medical Center are to: 1) characterize dopaminergic dysfunction in LLD across cognitive, emotional, and motor domains at several levels of analysis (cellular Positron Emission Tomography \[PET\], circuit Magnetic Resonance Imaging \[MRI\], and behavioral / self-report); and 2) examine the responsivity of dopamine-related circuits and behavior to stimulation with carbidopa/levodopa (L-DOPA).

First Posted: 2020-07-30

Condition(s): Depression, Cognitive Impairment, Gait Impairment

Intervention(s): Carbidopa/levodopa, Placebo

Status: TERMINATED

Enrollment (expected or actual): 5

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Bret Rutherford, Associate Professor of Clinical Psychiatry

Completion Date (primary or actual): 2021-10-27

CT.gov Identifier: NCT04493320

Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

Researchers are looking at the effects of a cannabidiol medication on stomach function in people with gastroparesis (a paralyzed stomach) and people with dyspepsia (an upset stomach caused by improper functioning of the stomach's muscles or nerves).

First Posted: 2019-05-07

Condition(s): Gastroparesis, Dyspepsia

Intervention(s): Cannabidiol, placebo

Status: COMPLETED

Enrollment (expected or actual): 92

Allocation: RANDOMIZED

Sponsor: Mayo Clinic

Principal Investigator: Michael Camilleri, MD, Principal Investigator

Completion Date (primary or actual): 2023-02-23

CT.gov Identifier: NCT03941288

Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain

Randomized, open-label, parallel-group phase III trial to prove an additional benefit of the full-spectrum cannabis extract VER-01 over opioids in patients with chronic non-specific low back pain for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

First Posted: 2022-11-09

Condition(s): Chronic Non-specific Low Back Pain

Intervention(s): VER-01, Opioid therapy

Status: COMPLETED

Enrollment (expected or actual): 384

Allocation: RANDOMIZED

Sponsor: Vertanical GmbH

Principal Investigator:

Completion Date (primary or actual): 2024-10-18

CT.gov Identifier: NCT05610813

Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients

Indonesian population's life expectancy has been increasing steadily in the last 3 decades. It potentially increases the prevalence of degenerative diseases, including osteoarthritis (OA). Serum Vitamin D (25(OH)D) level has been recognized as a risk factors for knee OA. Cartilage Oligomeric Matrix Protein (COMP) is cartilage degradation product can be used as a diagnostic marker for knee OA. This study aims to determine the effect of Vitamin D supplementation (Alphacalcidol) on pain based on WOMAC indicators and joint cartilage condition based on COMP serum markers in knee OA elderly patients.

First Posted: 2020-05-28

Condition(s): Osteoarthritis, Knee, Aged

Intervention(s): Alfacalcidol 1 MCG Oral Capsule, Sugar pill

Status: COMPLETED

Enrollment (expected or actual): 146

Allocation: RANDOMIZED

Sponsor: Syarif Hidayatullah State Islamic University Jakarta

Principal Investigator: Achmad Zaki, Doctor, Orthopedic Surgeon, Principal Investigator

Completion Date (primary or actual): 2017-12-31

CT.gov Identifier: NCT04405960

Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis

Phlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access. Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response. However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%. Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis. Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4. There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.

First Posted: 2023-09-08

Condition(s): Phlebitis, Peripheral Venous Catheterization

Intervention(s): sesame oil application, nigella sativa oil application

Status: COMPLETED

Enrollment (expected or actual): 108

Allocation: RANDOMIZED

Sponsor: Kutahya Health Sciences University

Principal Investigator: BURCU NAL, LECTURER

Completion Date (primary or actual): 2024-10-01

CT.gov Identifier: NCT06030141

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.

First Posted: 2023-04-18

Condition(s): Insomnia

Intervention(s): Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM), Sleep Hygiene Education (SHE-TM)

Status: RECRUITING

Enrollment (expected or actual): 200

Allocation: RANDOMIZED

Sponsor: University of Michigan

Principal Investigator: J. Todd Arnedt, Professor of Psychiatry, Professor of Neurology

Completion Date (primary or actual): 2027-07-31

CT.gov Identifier: NCT05814822

Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

First Posted: 2022-08-23

Condition(s): Sleep, Sleep Disturbance, Sleep Disorder

Intervention(s): Rest Study Product Usage

Status: COMPLETED

Enrollment (expected or actual): 2679

Allocation: RANDOMIZED

Sponsor: Radicle Science

Principal Investigator:

Completion Date (primary or actual): 2023-04-11

CT.gov Identifier: NCT05511818

Cannabis and Processing Emotions Study

The goal of this study is to test a causal neural mechanism of cannabis use-related problem recognition in individuals with severe cannabis use disorder using a non-invasive form of neuromodulation called transcranial magnetic stimulation (TMS). The main question it aims to answer is: -Does manipulating neural activity in the medial orbitofrontal cortex of the brain affect cannabis use-related problem recognition? Researchers will compare three forms of theta burst stimulation (TBS; sham, intermittent, and continuous) in each participant to see if manipulations in neural activity lead to changes in cannabis use-related problem recognition. Participants will complete a screening interview about their mental health and substance use history and complete four in-person laboratory sessions, which involve questionnaires, four brief magnetic resonance imaging (MRI) scans, three TBS sessions, and three electroencephalogram (EEG) sessions. Participants will also be asked to provide urine samples and take saliva and/or breathalyzer tests at some of the lab visits.

First Posted: 2025-04-03

Condition(s): Cannabis Use Disorder, Severe

Intervention(s): TMS - Sham, TMS - Active iTBS, TMS - Active cTBS

Status: RECRUITING

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: Auburn University

Principal Investigator: Samantha Fede, Assistant Professor

Completion Date (primary or actual): 2027-05

CT.gov Identifier: NCT06907979

Prevalence and Clinical Manifestations of Cannabis Withdrawal in Hospitalized Patients With Hematological Malignancies Undergoing Bone Marrow Transplant (BMT) or Chimeric Antigen Receptor T-Cell (CAR-T) Therapy

This study evaluates the prevalence of cannabis withdrawal and the clinical manifestations of cannabis withdrawal syndrome in patients hospitalized for BMT or CAR-T therapy.

First Posted: 2026-05-18

Condition(s): Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

Intervention(s): Non-Interventional Study

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 300

Allocation:

Sponsor: Mayo Clinic

Principal Investigator:

Completion Date (primary or actual): 2031-02-28

CT.gov Identifier: NCT07594496

Implementing Screening for Cannabis and Other Drug Use Disorders in Primary Care: Impact on Diagnosis and Treatment

Our proposed evaluation study is designed to evaluate the impact of a recently completed stepped wedge cluster randomized trial, conducted at Kaiser Permanente Washington (KPWA), of an intervention to improve care and management of patients with drug use disorders (DUDs) in primary care (Aim 1). We will also explore the reasons for any apparent gaps in DUD care by analyzing clinicians' free-text encounter notes using manual chart review, natural language processing (NLP), and/or NLP-assisted manual chart review, as appropriate (Aim 2). Specific Project Aims are as follows: Aim 1 The primary research question we address in Aim 1 is whether routine screening for drug use disorders in primary care (PC) settings increases DUD treatment. We define DUDs as including opioid use disorders (OUD), cannabis use disorders (CUD), and other non-alcohol drug use disorders (OTH). Previously published analyses indicate that the 22 PC clinics in this trial sustained very high rates of screening (88%) and a 3-clinic DUD pilot study suggested that this screening resulted in increased diagnosis of CUD and increased treatment of DUDs in general, even at relatively low observed rates of PC-based screening and assessment. Aim 2 The overall goal of Aim 2 is to expand our understanding of gaps in DUD diagnosis and treatment that persist-despite implementation of high rates of PC screening and assessment for SUDs-using rich information available only in free-text chart notes. Through analysis of relevant chart notes Aim 2 of this project will descriptively characterize gaps in DUD diagnosis and DUD treatment (i.e., instances where information in a patient's record suggests a DUD could be diagnosed but no diagnosis is present, or a new diagnosis suggest treatment is indicated but no evidence of treatment is present), and characterize reasons for DUD care gaps.

First Posted: 2024-02-08

Condition(s): Cannabis-Related Disorder, Cannabis Abuse, Drug Abuse, Drug Use Disorders, Opioid Use Disorder, Opioid Abuse, Substance Abuse, Substance Use Disorders

Intervention(s): Care Delivery Improvement Intervention

Status: COMPLETED

Enrollment (expected or actual): 363936

Allocation: RANDOMIZED

Sponsor: Kaiser Permanente

Principal Investigator:

Completion Date (primary or actual): 2024-07-31

CT.gov Identifier: NCT06249542

Pharmacokinetic Study With Repeated Doses of Stalevo

The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.

First Posted: 2008-06-09

Condition(s): Pharmacokinetics

Intervention(s): levodopa, carbidopa, entacapone, levodopa, carbidopa

Status: COMPLETED

Enrollment (expected or actual): 19

Allocation: RANDOMIZED

Sponsor: Orion Corporation, Orion Pharma

Principal Investigator:

Completion Date (primary or actual): 2008-05

CT.gov Identifier: NCT00693862

Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

First Posted: 2016-06-23

Condition(s): Cannabis

Intervention(s): Placebo, Dronabinol

Status: RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Mohini Ranganathan, Assistant Professor of Psychiatry

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT02811510

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.

First Posted: 2025-03-17

Condition(s): Depression - Major Depressive Disorder, Cannabis Use Disorder, Mental Disorder

Intervention(s): Amplification of Positivity - Cannabis Use (AMP-C)

Status: RECRUITING

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Massachusetts General Hospital

Principal Investigator: Amanda C. Collins, Principal Investigator

Completion Date (primary or actual): 2029-06-29

CT.gov Identifier: NCT06878859

Enhancing Recovery in Early Schizophrenia

Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.

First Posted: 2016-10-06

Condition(s): Schizophrenia

Intervention(s): Cannabidiol as add-on, Placebo as add-on

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 180

Allocation: RANDOMIZED

Sponsor: Central Institute of Mental Health, Mannheim

Principal Investigator:

Completion Date (primary or actual): 2027-12

CT.gov Identifier: NCT02926859

Project e-PBI+ - Parent Intervention to Reduce College Student Drinking and Cannabis Use

College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Both college health administrators and parents have requested electronic parent-based interventions (e-PBIs) with additional content on cannabis. Parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective e-PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the e-PBI that includes updated content including the most up-to-date scientific information from cannabis studies (e-PBI+).

First Posted: 2022-04-26

Condition(s): Underage Drinking, Cannabis Use, Drinking, Teen, Drinking, College, College Drinking, Teen Drinking

Intervention(s): e-PBI+, e-PBI

Status: COMPLETED

Enrollment (expected or actual): 1980

Allocation: RANDOMIZED

Sponsor: Penn State University

Principal Investigator: Robert Turrisi, Professor of Biobehavioral Health

Completion Date (primary or actual): 2026-05-31

CT.gov Identifier: NCT05345951

A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration

From 3 large patient databases, patients diagnosed with AMD who have never taken levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD at 79 years. L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects the retina and downregulates VEGF, which is the cause of neovascularization. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with AMD, and measure the effects on surrogate functional biomarkers of AMD.

First Posted: 2016-08-19

Condition(s): Age-related Macular Degeneration

Intervention(s): carbidopa-levodopa 25-100 mg, placebo for carbidopa-levodopa 25-100 mg

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Snyder, Robert W., M.D., Ph.D., P.C.

Principal Investigator:

Completion Date (primary or actual): 2020-12

CT.gov Identifier: NCT02873351

Two Bilateral Metal Stenting in Hilar Malignancy

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making allative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. In malignant hilar obstruction, exclusively endoscopic placement of bilateral metal stents has been considered very difficult and complex, and it may require multiple procedures, with an increased risk of complications and mortality. To overcome this difficulty and strategize plan of management, the investigators evaluated the technical and clinical efficacy of endoscopic bilateral placement of newly designed stents, Y-configuration, followed by side-by-side insertion in failure of stent-in-stent method for the management of malignant hilar obstruction.

First Posted: 2010-06-10

Condition(s): Malignant Hilar Stricture, Bilateral Stent Insertion

Intervention(s): Bilateral stent-in-stent insertion, Bilateral side-by-side insertion

Status: UNKNOWN

Enrollment (expected or actual): 80

Allocation: RANDOMIZED

Sponsor: Soon Chun Hyang University

Principal Investigator: Tae Hoon Lee, MD, PhD

Completion Date (primary or actual): 2018-09-30

CT.gov Identifier: NCT01141088

Effect of CBD-Based Vaginal Suppositories on Menopausal Symptoms

Efficacy and safety of the medical device CANNEFF® vaginal suppositories containing two active ingredients cannabidiol (CBD) and hyaluronic acid (HA) in alleviating menopausal symptoms and improving quality of life in (post)menopausal women will be evaluated.

First Posted: 2025-02-03

Condition(s): Menopause and Genitourinary Syndrome

Intervention(s): CANNEFF® VAG SUP vaginal suppositories, Placebo Suppositories

Status: COMPLETED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Palacky University

Principal Investigator: Jan Vacek, Olomouc University Hospital

Completion Date (primary or actual): 2024-02-01

CT.gov Identifier: NCT06804889

Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital

This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.

First Posted: 2025-02-19

Condition(s): Endometriosis, Endometriosis Related Pain, Endometriosis, Pain

Intervention(s): Dronabinol Capsules, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Baylor College of Medicine

Principal Investigator: Christopher D. Verrico, Associate Professor

Completion Date (primary or actual): 2028-12-30

CT.gov Identifier: NCT06834997

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

First Posted: 2004-12-10

Condition(s): Parkinson's Disease

Intervention(s): Carbidopa/levodopa/entacapone, Immediate release carbidopa/levodopa

Status: COMPLETED

Enrollment (expected or actual): 747

Allocation: RANDOMIZED

Sponsor: Novartis Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2008-11

CT.gov Identifier: NCT00099268

Varenicline for Co-occurring Cannabis and Tobacco Use

Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.

First Posted: 2020-10-20

Condition(s): Cannabis Dependence, Tobacco Dependence

Intervention(s): Standard clinical care first, followed by standard clinical care and varenicline, Standard clinical care and varenicline first, followed by standard clinical care

Status: COMPLETED

Enrollment (expected or actual): 7

Allocation: RANDOMIZED

Sponsor: Albert Einstein College of Medicine

Principal Investigator:

Completion Date (primary or actual): 2015-07

CT.gov Identifier: NCT04595318

Screening to Augment Referral to Treatment- Project START

The investigators propose to use obstetric-gynecological clinics to conduct a randomized clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and Treatment), delivered either by a trained nurse or by computer, to usual care (a control condition). As part of this trial, the investigators will include outcomes that allow us to assess the cost effectiveness of these three conditions.

First Posted: 2012-02-27

Condition(s): Alcohol Abuse, Tobacco Use Disorder, Marijuana Abuse, Substance-Related Disorders

Intervention(s): Motivational Interview, Treatment as Usual

Status: COMPLETED

Enrollment (expected or actual): 439

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator: Kimberly Yonkers, Professor

Completion Date (primary or actual): 2015-01-28

CT.gov Identifier: NCT01539525

CBD Stenting vs Non-Stenting for Choledocholithiasis

The role of prophylactic biliary stenting after complete clearance of common bile duct stones in patients awaiting cholecystectomy remains controversial. This randomized controlled trial investigates whether temporary plastic biliary stent placement after documented complete choledocholithiasis clearance reduces the recurrence of choledocholithiasis and biliary complications in patients awaiting cholecystectomy for concomitant cholelithiasis. Between March 2024 and September 2025, 200 patients with concomitant cholelithiasis and choledocholithiasis were randomized to either prophylactic biliary stenting (n=100) or no stenting (n=100) after complete stone clearance documented on occlusion cholangiogram during endoscopic retrograde cholangiopancreatography (ERCP). The primary outcome was symptomatic choledocholithiasis recurrence within 3 months. Secondary outcomes included biliary complications (cholangitis, cholecystitis, post-ERCP pancreatitis, bleeding), radiation exposure metrics, and cost-effectiveness.

First Posted: 2026-01-09

Condition(s): Choledocholithiasis

Intervention(s): Temporary Plastic Biliary Stent Placement, Endoscopic Retrograde Cholangiopancreatography with Stone Clearance

Status: COMPLETED

Enrollment (expected or actual): 200

Allocation: RANDOMIZED

Sponsor: National Liver Institute, Egypt

Principal Investigator:

Completion Date (primary or actual): 2025-11-01

CT.gov Identifier: NCT07331142

Pharmacokinetic Evaluation of a Natural CBD Extract

The present cross-over study investigated whether cannabidiol (CBD) or its metabolites and delta-9-tetrahydrocannabinol (THC) can be detected in the systemic circulation following a single topical application of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium chain triglycerides (capric, caprylic triglycerides or medium chain triglycerides (MCT)) derived from coconut oil. Since consumers can consider hemp/CBD oil as a nutritional product or dietary supplement, it can be ingested by consumers. Therefore, we analyzed the concentrations of CBD, THC, and their metabolites in systemic circulation after oral NHEC administration. Additionally, we tested whether a single topical or oral use of the NHEC would lead to detectable levels of THC in the urine samples using Easy@Home THC detection strips. This study has no intent to treat or prevent any diseases or conditions. In this study, volunteer participants were assigned to one of two study groups: Cohort A (oral administration) or Cohort B (topical administration). After completing the study in the first assigned Cohort, participants had a 15-day washout period before beginning the study in the next Cohort.

First Posted: 2026-01-22

Condition(s): Pharmacokinetics of CBD Extract, Oral and Topical Administrations

Intervention(s): CBD extract

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: University of Utah

Principal Investigator: Elena Enioutina, Research Associate Professor

Completion Date (primary or actual): 2025-01-16

CT.gov Identifier: NCT07359976

Efficacy of Co-administration of an NSAID With a Dopamine Agonist In Healthy Subjects

Findings from the investigator's lab and others' show the involvement of the brain's mesolimbic circuitry in pain perception and evaluation, as well as during the transition from acute to chronic pain states in both humans and animals. Dopamine (DA) is one of the main neurotransmitters in this circuitry, and it is possible it could have an intimate role in pain processing, chronicity, and related anatomical and functional neuroplasticity. In this study, the investigators first need to know if the combination of l-dopa and Naproxen is safe and efficacious in humans with acute pain, and if so, at what doses. For the present study, healthy pain-free participants will be injected with a small bolus of capsaicin subcutaneously to induce acute cutaneous inflammatory pain. Capsaicin is ideal for this study because it causes a characteristic inflammatory response that is almost always accompanied with pain, has a well-validated dose-response curve, and has effects that will go away completely in a few hours after administration, causing no permanent damage to study subjects. Effects of capsaicin will be measured by changes (decreases) from baseline in thermal and tactile thresholds, as well as by verbally reported cutaneous pain levels (on a scale from 0-10). Participants will also be given study medication in the form of a placebo, one drug, or a combination of drugs before capsaicin injection to allow for any analgesic effects to peak before pain onset. For those receiving active medication, they will either receive Naproxen with placebo or the combination of naproxen and l-dopa (the latter of which will be in one of two different doses). This will allow the investigators to investigate (1) whether co-administration of naproxen and l-dopa has analgesic effects in low levels of acute pain in humans, (2) if this combination is pain-alleviating, whether it is equally as or more efficacious than naproxen, which is the clinical standard of treatment, and finally (3) what dose provides the most analgesia.

First Posted: 2014-04-17

Condition(s): Acute Pain

Intervention(s): Naproxen, Sinemet, Sinemet, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Northwestern University

Principal Investigator: Apkar Apkarian, Professor

Completion Date (primary or actual): 2015-01

CT.gov Identifier: NCT02116790

Effects of Dronabinol in Opioid Maintained Patients

Twenty male and female (ages 18-70) participants with OUD currently receiving methadone or buprenorphine will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive dronabinol (2.5 mg, 5mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes. Pain sensitivity will be measured using a technique called the (QST) quantitative sensory testing, which involves the administering heat or cold stimulation. A Short-Form McGill Pain Questionnaire (SF-MPQ) and a pain Visual Analog Scale (VAS). Attentional bias will be measured using a visual probe task. Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be measured by a comprehensive cognitive battery. The order of study medication administration will be counterbalanced order to minimize carryover effects. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum cytokine levels. One week after the last study medication dose, a follow-up session will be conducted during which participants will undergo urine toxicology testing and a safety evaluation before final discharge from the study.

First Posted: 2019-07-18

Condition(s): Pain

Intervention(s): Dronabinol, Dronabinol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): 2027-01-31

CT.gov Identifier: NCT04025359

Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm

The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.

First Posted: 2020-06-09

Condition(s): Blepharospasm, Blepharospasm, Benign Essential, CBD

Intervention(s): Cannabidiol Oral Solution [Epidiolex]

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: Silkiss Eye Surgery

Principal Investigator: Rona Silkiss, MD FACS, Physician

Completion Date (primary or actual): 2021-10-01

CT.gov Identifier: NCT04423341

CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors

This study is an open, exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells in patients with Claudin6, GPC3, Mesothelin, or AXL-positive advanced solid tumors (ovarian cancer and others)

First Posted: 2022-06-08

Condition(s): Stage IV Ovarian Cancer, Testis Cancer, Refractory, Endometrial Cancer Recurrent, CAR NK

Intervention(s): Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells

Status: RECRUITING

Enrollment (expected or actual): 200

Allocation: RANDOMIZED

Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Principal Investigator:

Completion Date (primary or actual): 2036-05-31

CT.gov Identifier: NCT05410717

Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis

Endometriosis is a complex gynecological condition that affects approximately 10% of women of reproductive age, according to 2023 data from the World Health Organization. Endometriosis is often associated with debilitating pain, particularly during sexual intercourse (dyspareunia). This pain profoundly affects these patients' sexual health and, consequently, their quality of life, yet it remains frequently misunderstood and inadequately managed, partly due to a lack of information and appropriate tools. One of the key aspects of this study is the use of the Sexual Activity Questionnaire (SAQ), an internationally recognized assessment tool for measuring the impact of treatment on sexual functioning. The SAQ collects precise data on sexual activity (primarily frequency), the level of sexual pleasure, and the perceived pain potential experienced by patients during sexual activity, assessing not only the intensity of pain but also its influence on the emotional and relational aspects of intimate life. The SAQ has been validated to assess the impact of surgical treatments for endometriosis on sexual functioning. The results obtained through this questionnaire in routine clinical practice formed the basis for the tools developed by Dr. Magalie Benoit, providing an in-depth understanding of the different types of pain experienced by patients. The kit used in the study contains: 1. The Endo-Sexo Guide: A 258-page book that compiles and analyzes possible responses to the SAQ. It explains in detail the mechanisms of sexual pain and offers personalized solutions to alleviate it. 2. The Endo Doute app: It allows women to keep a journal tracking pain (frequency and intensity), the frequency of sexual intercourse, and the tools used to relieve pain (including those provided in the kit). It also allows users to export their data to share with the healthcare professionals involved. 3. A set of practical tools for managing sexual pain on a daily basis, including an endo-vaginal TENS device to treat dyspareunia, penis rings to limit deep penetration, hyaluronic acid suppositories, CBD (cannabinoid) lubricant gel, sublingual CBD oil to reduce stress, as well as two dietary supplements-one containing palmitoylethanolamide (PEA) to combat inflammation and the other made from herbs to aid menstrual comfort. These tools will be used independently by patients, offering them personalized solutions to better understand and manage their pain on their own. Each patient will be able to choose whether or not to use the various components of the kit and how often to use them. Empowering patients to manage their own pain should improve their sexual quality of life and reduce the need for occasional or unscheduled medical care. This project represents the first initiative aimed at evaluating the impact of these tools on patients' autonomy in managing sexual pain related to endometriosis.

First Posted: 2026-07-06

Condition(s): Endometriosis

Intervention(s): Specialized kit

Status: RECRUITING

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Elsan

Principal Investigator:

Completion Date (primary or actual): 2027-06

CT.gov Identifier: NCT07683468

Research Investigating Drug Effects-2 (RiDE-2)

The purpose of this study is to better understand how people's mood, behavior, and brains respond to different recreational drugs. We are also trying to understand why some people may feel differently or their brain may respond differently than other people after taking the same recreational drug.

First Posted: 2025-01-06

Condition(s): Cannabis Use, Substance Use Disorder (SUD), Healthy

Intervention(s): Placebo Oral Capsule, THC

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 144

Allocation: RANDOMIZED

Sponsor: University of Illinois at Chicago

Principal Investigator:

Completion Date (primary or actual): 2031-06

CT.gov Identifier: NCT06758596

Safety Study of TPI-287 to Treat CBS and PSP

The purpose of this study is to determine the safety and tolerability \[maximum tolerated dose (MTD) within planned dosing range\] of intravenous (IV) infusions of TPI 287 administered once every 3 weeks for 9 weeks (for a total of 4 infusions) in patients with primary four repeat tauopathies (4RT), corticobasal syndrome (CBS; also called corticobasal degeneration, CBD) or progressive supranuclear palsy (PSP).

First Posted: 2014-05-08

Condition(s): Primary Four Repeat Tauopathies (4RT), Corticobasal Syndrome (CBS), Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)

Intervention(s): TPI 287 2 mg/m2, TPI-287 20 mg/m2, Placebo, TPI-287 6.3 mg/m2

Status: COMPLETED

Enrollment (expected or actual): 44

Allocation: RANDOMIZED

Sponsor: University of California, San Francisco

Principal Investigator: Adam Boxer, Adam Boxer, M.D., Ph.D.

Completion Date (primary or actual): 2019-09

CT.gov Identifier: NCT02133846

Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with pain disorders due to diabetic polyneuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to diabetic polyneuropathy.

First Posted: 2023-10-10

Condition(s): Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Diabetes, Diabetic Neuropathies, Diabetic Polyneuropathy, Peripheral Neuralgia, Peripheral Neuropathy, Peripheral Neuropathy With Type 2 Diabetis

Intervention(s): Adezunap (AP707), Placebo

Status: UNKNOWN

Enrollment (expected or actual): 558

Allocation: RANDOMIZED

Sponsor: Apurano Pharmaceuticals GmbH

Principal Investigator:

Completion Date (primary or actual): 2024-12-31

CT.gov Identifier: NCT06072573

An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut syndromes.

First Posted: 2014-08-25

Condition(s): Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome

Intervention(s): GWP42003-P

Status: COMPLETED

Enrollment (expected or actual): 681

Allocation: NA

Sponsor: GW Research Ltd

Principal Investigator:

Completion Date (primary or actual): 2020-09-24

CT.gov Identifier: NCT02224573

Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques. Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.

First Posted: 2023-08-25

Condition(s): Common Bile Duct Calculi, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction, Acute Cholangitis

Intervention(s): Modified laparoscopic transcystic biliary drainage

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 310

Allocation: NA

Sponsor: Peking University Third Hospital

Principal Investigator:

Completion Date (primary or actual): 2027-07-01

CT.gov Identifier: NCT06011941

Hair Testing to Assess Consumption of Illicit Psychotropic Agents and Alcohol by Patients Treated With High-dose Buprenorphine and Methadone. Search for a Pharmacogenetic Contribution to Low Efficacy of Substitution Medications

Justification and aims of the study: The principal aim of use of opiate substitutes such as methadone or high-dose buprenorphine (HDB) is to reduce the need or the desire to consume the opiate to which the patient is addicted. Adjustment of the initial dose and regular re-evaluation of the efficacy of treatment are key elements in the success of such management. While too high a dose can be responsible for side effects leading to abandonment of treatment, too low a dose can induce the reappearance or even the reinforcing of parallel consumption of other psychoactive substances, in particular cocaine, alcohol and cannabis. The principal aim of this project is to determine the course of parallel consumption in patients who have been receiving a maintenance dose of methadone or HDB for at least two months, by analysis of a sample of hair, a biological matrix which is innovative for this type of study. Hair testing establishes a retrospective profile of consumption. The secondary aims of this project are (i) to validate the French versions of Handelsman's subjective and objective opiate withdrawal scales and to seek a possible correlation between high scores on these scales and the presence of parallel consumption, and (ii) to seek an association between polyconsumption and common functional polymorphisms of metabolic enzymes of methadone and HDB. Expected results: Hair testing, which has the particular advantage of a long detection window so that samples need only be taken at intervals, could improve the biological monitoring of patients on substitutive treatment. Validation of the French version of Handelsman's scales of objective and subjective signs of opiate withdrawal and search for any correlation with parallel consumption will enable these scales to be used in daily practice for clinical surveillance of patients on substitutive treatment. If a polymorphism of a metabolic enzyme of one or other of these molecules is detected, rapid genotyping of a simple saliva sample will be valuable in guiding the choice of medication when deciding on a treatment strategy

First Posted: 2011-01-28

Condition(s): Substance Abuse

Intervention(s): hair and saliva samples

Status: UNKNOWN

Enrollment (expected or actual): 220

Allocation: NON_RANDOMIZED

Sponsor: Assistance Publique Hopitaux De Marseille

Principal Investigator:

Completion Date (primary or actual): 2015-08

CT.gov Identifier: NCT01285856

Safety and Tolerability of Namisol in the Elderly

The results of phase I Namisol® study (Klumpers et al. Br J Clin Pharmacol, 2012), implicate that Namisol® may have a favorable PK and PD characteristics and is safe to use in people. However, the study included only young adults with a mean age of 21.4 years. In a previous THC study, subjects age has been associated with treatment response and tolerance of adverse reactions. This association was not supported by Lane et al. and Volicer et al. There is concern about the safety and tolerability of THC in the elderly population. This is because, elderly persons in general have higher risk of adverse drug reactions due to a combination of physiological factors such as decreasing in lean body mass, the reduction of renal and hepatic clearance, and medical comorbidity which can lead to polypharmacy and drug-drug interactions. Therefore, data from the phase I trial cannot be translated directly to an elderly (and likely more vulnerable) population. This makes it important to evaluate the safety and tolerability profiles of different Namisol® doses in the elderly. In our study in progress "Delta-THC in Behavioral Disturbances in Dementia", the Namisol® doses of 0,75 mg and 1,5 mg are, until now, well tolerated by elderly subjects. These doses are, however, very low in comparison with the doses used in phase I study with young adults (5 mg, 6,5 mg and 8 mg). The current study on the safety and tolerability of relatively high doses of Namisol® will help us in the future to provide broad advice on the therapeutic index and safety profile of Namisol® in the elderly population.

First Posted: 2012-12-04

Condition(s): Drug Safety

Intervention(s): delta-9-tetrahydrocannabinol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: Radboud University Medical Center

Principal Investigator:

Completion Date (primary or actual): 2012-12

CT.gov Identifier: NCT01740960

Istradefylline Effect Protocol on Parkinson's Disease Tremor

This is an investigator-initiated trial. In this 6-month open label, single arm, exploratory pilot study, the investigator intends to enroll a pilot sample of 25 patients with Parkinson's disease who are being started on the novel FDA approved medication "Istradefylline'' as an add on therapy for management of their motor symptoms (based on the judgment of the movement disorders specialist, if patients are in sub-optimal management of their symptoms on maximum tolerable dose of their dopaminergic medications). The investigator will evaluate their motor symptoms before starting the new medication, including their MDS-UPDRS total and MDS-UPDRS-III scores.

First Posted: 2023-06-01

Condition(s): Parkinson Disease, Tremor

Intervention(s): Istradefylline Pill

Status: COMPLETED

Enrollment (expected or actual): 27

Allocation: NA

Sponsor: Georgetown University

Principal Investigator:

Completion Date (primary or actual): 2025-02-21

CT.gov Identifier: NCT05885360

Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder

This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).

First Posted: 2021-02-09

Condition(s): Autism Spectrum Disorder

Intervention(s): GWP42003-P, Placebo

Status: COMPLETED

Enrollment (expected or actual): 103

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2023-12-21

CT.gov Identifier: NCT04745026

Effects of Drugs on Stress Memories

There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.

First Posted: 2024-06-24

Condition(s): Delta-9-tetrahydrocannabinol (THC), Stress

Intervention(s): delta-9-tetrahydrocannabinol (THC) (5), Placebo, delta-9-tetrahydrocannabinol (THC) (10)

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: University of Chicago

Principal Investigator:

Completion Date (primary or actual): 2025-03-25

CT.gov Identifier: NCT06471647

Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder (SToP-C-rTMS x CUD)

This study is to explore if repetitive transcrinal magnetic stimulation (rTMS) with different stimulation schedules will be equally effective in reducing carving, frequency of cannabis use, and the severity of cannabis use disorder in participants suffering from cannabis use disorder (CUD). The investigators assume the hypotheses as: 1. Multiple rTMS sessions can reduce craving for cannabis, severity of CUD, frequency and amount of cannabis use. 2. Different rTMS treatment schedules have differences in reducing the craving for cannabis and severity of CUD, and prolonging relapse of cannabis use.

First Posted: 2022-03-23

Condition(s): Cannabis Use Disorder, Repetitive Transcranial Magnetic Stimulation

Intervention(s): Repetitive Transcranial Magnetic Stimulation

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: The University of Hong Kong

Principal Investigator:

Completion Date (primary or actual): 2025-03-31

CT.gov Identifier: NCT05292547

Effectiveness of Take it Personal!

A controlled pre-post design study on Take it Personal! has demonstrated effectiveness in reducing the frequency and severity of youth use of alcohol, cannabis or other illicit drugs. Take it Personal! is an existing indicated prevention programme for substance use in youth with a mild intellectual disability or borderline intellectual functioning that addresses each participant's high-risk personality traits for substance abuse. The current Take it Personal! programme is further developed and optimized in collaboration with relevant stakeholders. In particular, the investigators aim to integrate personalized daily diary monitoring in the programme so that trainers can monitor client progresses closely and gain insights into change mechanisms, providing starting points for therapeutic efforts in programme sessions. The investigators conduct a series of case studies with a non-concurrent multiple baseline design to evaluate the effectiveness of Take it Personal!. The baseline lengths are randomly determined, and therefore the start of the intervention is staggered across participants.

First Posted: 2023-05-06

Condition(s): Alcohol Use, Drug Use, Mild Intellectual Disability, IQ 50-70, Borderline Intellectual Disabilities (Intelligence Quotient 70-85), Personality, Adolescent Behavior

Intervention(s): Take it Personal!

Status: UNKNOWN

Enrollment (expected or actual): 15

Allocation: NA

Sponsor: Behavioural Science Institute

Principal Investigator:

Completion Date (primary or actual): 2024-08-01

CT.gov Identifier: NCT05843474

Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting

Single-stent strategy with provisional approach represents the gold standard for percutaneous coronary intervention of bifurcation lesions, and, according to European Bifurcation Club, performing provisional approach presents two steps considered as mandatory: "crossover stenting" in main vessel (MV) and subsequent post-dilation or "POT" (proximal optimization technique). While consensus exists regarding these first two steps, the exact optimal following sequence in case of side branch (SB) jeopardize after main vessel stenting is still a matter of debate. Actually, the two most used techniques in this setting are represented by the simultaneous inflation of two balloons located respectively in the MV and SB followed by a second POT (POT/kissing balloon/POT technique) and the isolated inflation of a balloon placed in the SB followed by a second POT (POT/SIDE/POT technique). The objective of this study is to compare the configuration achieved with POT/KISS/POT (PKP) and POT/SIDE/POT (PSP), using the "cutting edge" high-resolution intracoronary imaging modality (Optical Coherence Tomography, OCT).

First Posted: 2022-09-29

Condition(s): Ischemic Heart Disease

Intervention(s): OCT

Status: UNKNOWN

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Catholic University of the Sacred Heart

Principal Investigator: Francesco Burzotta, Principal investigator

Completion Date (primary or actual): 2023-07

CT.gov Identifier: NCT05559424

Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer

Phase III, single-center, randomized, double-blind, placebo-controlled, 2x2 cross- over study, assessing the efficacy of CBD in patients with early HR+ BC, presenting aromatase inhibitor-related musculoskeletal pain

First Posted: 2025-01-22

Condition(s): Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, HR+ Breast Cancer, AI-related Musculoskeletal Pain

Intervention(s): CBD oil, Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 130

Allocation: RANDOMIZED

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Principal Investigator:

Completion Date (primary or actual): 2027-05

CT.gov Identifier: NCT06787118

Young Adult Tobacco/Nicotine and Cannabis Co-use

The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

First Posted: 2024-02-02

Condition(s): Tobacco Use Disorder, Nicotine Dependence

Intervention(s): Counseling, Contingency management, Text-based support

Status: RECRUITING

Enrollment (expected or actual): 350

Allocation: NA

Sponsor: Medical University of South Carolina

Principal Investigator: Erin McClure, Professor - Faculty

Completion Date (primary or actual): 2028-01-03

CT.gov Identifier: NCT06239350

A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones

The purpose of this study is to determine if CBD oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.

First Posted: 2020-05-14

Condition(s): Urinary Stone

Intervention(s): Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 90

Allocation: RANDOMIZED

Sponsor: Mayo Clinic

Principal Investigator: Karen L. Stern, Principal Investigator

Completion Date (primary or actual): 2022-01-31

CT.gov Identifier: NCT04387617

Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy

The aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years

First Posted: 2020-01-31

Condition(s): Biliary Stricture, Jaundice, Obstructive

Intervention(s): Biliary brushing with the RX Cytology brush, Boston Scientific, Biliary brushing with the Infinity® brush, US Endoscopy

Status: COMPLETED

Enrollment (expected or actual): 51

Allocation: RANDOMIZED

Sponsor: Société Française d'Endoscopie Digestive

Principal Investigator: KARSENTI, Principal Investigator

Completion Date (primary or actual): 2022-03-01

CT.gov Identifier: NCT04251013

Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug

The overall goal of this project is to determine whether common sleep disturbance patterns, sleep continuity disturbance (SCD) and Sleep Fragmentation (SF), alter cerebral study drug receptor availability, drug-based analgesia, and drug abuse liability. The investigators specifically aim to: 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked receptor binding potential in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response and abuse liability profile of a study medication; and 3) determine whether receptor binding potentials in brain regions of interest are associated with study medication analgesia and abuse liability. The investigators will also evaluate the extent to which associations differ by sleep condition or sex.

First Posted: 2020-03-06

Condition(s): Sleep Disorder, Healthy

Intervention(s): Sleep Fragmentation, Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo), Sleep Continuity Disruption, Undisturbed Sleep

Status: COMPLETED

Enrollment (expected or actual): 148

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2025-08-31

CT.gov Identifier: NCT04299490

Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC

This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft failure and to aid in immune reconstitution following hematopoietic stem cell transplantation.

First Posted: 2020-08-27

Condition(s): Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias, Inflammatory Conditions

Intervention(s): data collection

Status: RECRUITING

Enrollment (expected or actual): 50

Allocation:

Sponsor: Paul Szabolcs

Principal Investigator: Paul Szabolcs, Chief, BMT-CT at CHP of UPMC and Professor of Pediatrics and Immunology, University of Pittsburgh

Completion Date (primary or actual): 2028-06-30

CT.gov Identifier: NCT04528355

Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy

The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days

First Posted: 2012-05-30

Condition(s): Eradication Rates of the Two Regimens

Intervention(s): D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole), D1-D14: (lansoprazole + clarithromycin + amoxicillin)

Status: UNKNOWN

Enrollment (expected or actual): 1300

Allocation: RANDOMIZED

Sponsor: National Taiwan University Hospital

Principal Investigator: National Taiwan University Hospital, Doctor and Principle Investigator, Department of Gastroenterology

Completion Date (primary or actual): 2014-06

CT.gov Identifier: NCT01607918

Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis

A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population. The present trial is designed to test whether cannabidiol (CBD), a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol (THC), can reduce psychiatric symptoms, cognitive deficits, and cannabis use in people with recent-onset psychosis who regularly consume cannabis.

First Posted: 2019-03-20

Condition(s): Schizophrenia Spectrum Disorders, Cannabis Use

Intervention(s): Cannabidiol (CBD), Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: University of Maryland, Baltimore

Principal Investigator: Britta Hahn, Associate Professor

Completion Date (primary or actual): 2050-03

CT.gov Identifier: NCT03883360

Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

This study is being done to find the effect of Dibenzyl Trisulphide (active ingredient in Guinea Hen Weed in combination in patients with stage four cancer of the breast, prostate, cervix and colon.

First Posted: 2019-10-02

Condition(s): Stage IV Prostate Cancer, Stage IV Colon Cancer, Stage IV Breast Cancer, Stage IV Cancer of the Cervix

Intervention(s): Dibenzyl trisulphide capsules, Dibenzyl trisulphide capsules, Dibenzyl trisulphide capsules, Dibenzyl trisulphide capsules, Stage IV Breast Cancer Placebo, Stage IV: Colon Cancer Placebo, Cervical Cancer Stage IV Placebo, Cancer of the Prostate Placebo

Status: UNKNOWN

Enrollment (expected or actual): 104

Allocation: RANDOMIZED

Sponsor: The University of The West Indies

Principal Investigator:

Completion Date (primary or actual): 2020-09-30

CT.gov Identifier: NCT04113096

Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects

In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout period (dosing interval) between doses will be at least 2 days. Taking the washout period of 2 days as an example, all subjects will take the corresponding medication according to the randomization table on day 1 of the first cycle trial, day 3 of the second cycle trial, day 5 of the third cycle trial, and day 7 of the fourth cycle trial.

First Posted: 2023-12-22

Condition(s): Healthy

Intervention(s): Test (T) Entacapone,Levodopa and Carbidopa Tablets (II), Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)

Status: UNKNOWN

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: The Affiliated Hospital of Qingdao University

Principal Investigator: Cao Yu, Director of Clinical Trials Center of Affiliated Hospital of Qingdao Universit

Completion Date (primary or actual): 2024-11-20

CT.gov Identifier: NCT06180720

Suppression of Upper Lip Hair Growth Using Novel Hemp Extract

A clinical case series will be conducted measuring upper lip hair suppression for cosmetic effects in a group of 25 adult women with hirsutism of the upper lip. The study will use a topical phytonutraceutical that contains two ingredients that have been shown to suppress hair growth. The serum contains Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract (0.15%) known to stimulate cannabinoid one (CB1) receptors. The subjects will use the serum nightly for 60 days. High-power ProScope photographs will be obtained at the philtrum (above the center of the upper lip) as a landmark. Prior to starting the serum subjects will grow their upper lip hair for seven days. Hair shafts will be counted and graded for thickness and color using a standard methodology. The subjects will then use the serum for 60 days and will not be allowed to use laser, waxing, bleaching or tweezing during the duration of the study. Only shaving will be allowed. At the end of the 60 day course the subjects will grow their lip hair for seven days and the high-power photographs will be repeated at the same location based on landmarks. An independent board-certified dermatologist will evaluate and grade the pre- and post- serum photographs for cosmetic effects, number and thickness of the hairs.

First Posted: 2023-08-21

Condition(s): Hirsutism, Hair Diseases

Intervention(s): Narcissus Tazetta Bulb Extract and Novel Hemp Extract

Status: UNKNOWN

Enrollment (expected or actual): 25

Allocation:

Sponsor: Medical Life Care Planners, LLC

Principal Investigator: Gregory L Smith, MD, MPH, Principal Investigaor

Completion Date (primary or actual): 2023-12-01

CT.gov Identifier: NCT06003062

Treatment of Orthostatic Hypotension in Autonomic Failure

The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.

First Posted: 2005-09-22

Condition(s): Autonomic Failure, Orthostatic Hypotension

Intervention(s): Atomoxetine, Acarbose, Pyridostigmine Bromide, Yohimbine, Midodrine HCl, placebo, Modafinil, Octreotide, water intake, Diphenhydramine Hydrochloride, Ranitidine HCL, Tranylcypromine, Ergotamine/ Caffeine, Celecoxib, Pseudoephedrine, Methylphenidate, Indomethacin, Ibuprofen, Oxymetazoline 0.05% nasal solution, Bovril, Acetazolamide, Rivastigmine tartrate, Carbidopa/levodopa, Inflatable abdominal binder, inflatable abdominal binder (sham)

Status: COMPLETED

Enrollment (expected or actual): 389

Allocation: RANDOMIZED

Sponsor: Vanderbilt University

Principal Investigator: Italo Biaggioni, Professor of Medicine and Pharmacology

Completion Date (primary or actual): 2017-01

CT.gov Identifier: NCT00223691

Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in Diabetes Mellitus

This study investigates the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group.

First Posted: 2023-01-26

Condition(s): Type 2 Diabetes

Intervention(s): Capsules containing the combination products, Placebo capsules

Status: UNKNOWN

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Tabriz University of Medical Sciences

Principal Investigator: Dr. Saeid Safiri, Principal Investigator

Completion Date (primary or actual): 2025-02-28

CT.gov Identifier: NCT05700513

Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy

The purpose of this study is to evaluate the effectiveness of methadone alone and in combination with SAB378 for the treatment of painful HIV-associated neuropathy.

First Posted: 2008-07-29

Condition(s): HIV-associated Neuropathy, Polyneuropathy

Intervention(s): SAB378, methadone, SAB placebo, Methadone placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Washington University School of Medicine

Principal Investigator:

Completion Date (primary or actual): 2010-01

CT.gov Identifier: NCT00723918

Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

This study is a critically important first-of-its-kind investigation of the potential research utility of using contingency management to examine long-term changes in cannabis use with six months of abstinence. These pilot data will inform a later trial which will focus on testing the longitudinal relationships between adolescent cognition and cannabis use, questions of high and growing public health significance given adolescents' increased access to cannabis with legalization.

First Posted: 2018-12-24

Condition(s): Cannabis Use, Adolescent Behavior

Intervention(s): Contingency Management

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: NA

Sponsor: Massachusetts General Hospital

Principal Investigator: Randi Melissa Schuster, Assistant Professor

Completion Date (primary or actual): 2019-12-06

CT.gov Identifier: NCT03786224

Evaluation of the Interactions of Cannabidiol (CBD) With Morphine

The purpose of this study is to analyze drug-drug interactions of CBD on co-administered Morphine as first step in understanding CBD-opioid interactions.

First Posted: 2021-12-03

Condition(s): Opioid Use Disorder

Intervention(s): Morphine Sulfate

Status: UNKNOWN

Enrollment (expected or actual): 60

Allocation: NON_RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2024-12-01

CT.gov Identifier: NCT05143424

Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD

Evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin application in patients with TMD

First Posted: 2019-06-21

Condition(s): Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography

Intervention(s): Cannabis Cream, Placebo Cream

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Medical University of Silesia

Principal Investigator: Aleksandra Nitecka-Buchta, Principal Investigator

Completion Date (primary or actual): 2019-01-01

CT.gov Identifier: NCT03994640

Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage

The objective of the study is to demonstrate whether cooling the uterine smooth muscle during cesarean section (following delivery of the fetus) will promote better uterine contraction and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section. The investigators suspect that it may.

First Posted: 2014-09-01

Condition(s): Postpartum Hemorrhage, Uterine Atony

Intervention(s): Uterine Cooling

Status: COMPLETED

Enrollment (expected or actual): 200

Allocation: RANDOMIZED

Sponsor: Baylor Research Institute

Principal Investigator:

Completion Date (primary or actual): 2014-08

CT.gov Identifier: NCT02229513

A Brief Intervention for Cannabis Use

The purpose of this study is to compare two brief interventions targeting potentially problematic cannabis use in emerging adults (ages 18-25). Brief interventions are two 40-50 minute sessions separated by 1 week. Eligible emerging adults will complete a detailed cannabis assessment (biological and self-report), followed by one of the two brief interventions, and four follow-up assessments: one immediately after the second session and at 1-, 3-, and 6-months post-intervention. Assignment to the brief intervention is random. Salivary samples will be collected at baseline, post-intervention, and all follow-ups, for a total of 5 samples, to be tested for tetrahydrocannabinol (THC) and cannabidiol (CBD).

First Posted: 2024-05-02

Condition(s): Cannabis Use Disorder

Intervention(s): Health Education (HealthEdu), Bloom

Status: RECRUITING

Enrollment (expected or actual): 62

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator: Kathryn Gex, Assistant Professor-Faculty

Completion Date (primary or actual): 2029-05

CT.gov Identifier: NCT06395389

A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE

The efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE).

First Posted: 2026-07-23

Condition(s): Developmental and Epileptic Encephalopathy (DEE)

Intervention(s): CBD-OS, Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2029-09-04

CT.gov Identifier: NCT07723976

Substance Use Interventions for Truant Adolescents

This study evaluates a brief motivation-building intervention for parents and teens to reduce truancy and substance use. It is hypothesized that the motivational intervention will result in better outcomes compared to an education-only intervention.

First Posted: 2018-08-31

Condition(s): Adolescent Problem Behavior, Truancy; Unsocialized, Marijuana Abuse, Truancy; Socialized, Substance Abuse, Alcohol Abuse

Intervention(s): Motivational + Family Check-up (MET+FCU), Psychoeducation

Status: COMPLETED

Enrollment (expected or actual): 110

Allocation: RANDOMIZED

Sponsor: Brown University

Principal Investigator:

Completion Date (primary or actual): 2024-04-30

CT.gov Identifier: NCT03655574

Neuromolecular Risk Factors for Obesity (PROSPECT)

The goal of this project is to characterize the neural and psychological mechanisms that contribute to development of obesity in the early adulthood. We address the neuromolecular risk factors for obesity using multi-modal molecular (positron emission tomography with) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. Normal weight adolescents with high versus low familial, genetic and psychological risk factors for obesity will be studied and followed for five years.

First Posted: 2017-04-10

Condition(s): Obesity

Intervention(s): fMRI imaging, [11C]carfentanil PET scan, [18F]FMPEP-d2 PET scan, [18F]-FDG PET scan, Physical activity measures and fitness tests, Laboratory measurements, Questionnaires, Hyperinsulinemic euglycemic clamp

Status: UNKNOWN

Enrollment (expected or actual): 60

Allocation: NON_RANDOMIZED

Sponsor: Turku University Hospital

Principal Investigator: Pirjo Nuutila, Professor

Completion Date (primary or actual): 2022-12-01

CT.gov Identifier: NCT03106688

A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease

The major purpose of this study is to assess the efficacy of CBD on motor symptoms of Parkinson's Disease (PD), and secondarily to study the safety and tolerability of CBD and other efficacy, particularly regarding tremor in PD. The study has been powered to detect a clinically significant reduction in Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor scores. This is a 1:1 parallel, double-blind, randomized controlled trial (RCT) with 60 participants. The investigators will be recruiting up to 75 participants; the goal is to have 60 participants (30 in CBD group and 30 in placebo group) complete the study. The study drug is obtained from the National Institute on Drug Abuse (NIDA).

First Posted: 2018-07-10

Condition(s): Parkinson Disease

Intervention(s): Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 74

Allocation: RANDOMIZED

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2022-01-04

CT.gov Identifier: NCT03582137

Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo.

First Posted: 2020-12-22

Condition(s): Diabetic Peripheral Neuropathic Pain

Intervention(s): CBD, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Pure Green

Principal Investigator:

Completion Date (primary or actual): 2021-04-01

CT.gov Identifier: NCT04679545

Meta-analysis of Oat Fiber and Cardiovascular Risk Reduction

Oat fibre has been shown to lower cholesterol and may have cardioprotective effects. However, whether this translates to actual cardiovascular risk reduction is unclear, as there is a lack of controlled human trials. To address this uncertainty, the investigator proposes to use established cardiovascular disease risk scores, such as those recommended by the Canadian Cardiovascular Society and other clinical practice groups, to create composite risk scores in assessing future risk. The data on oat fibre will be collected through a systematic review of controlled trials, composite cardiovascular risk scores will be calculated for each eligible study, and meta-analyses will be conducted to assess the overall effect. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.

First Posted: 2021-12-28

Condition(s): Cardiovascular Diseases, Coronary Heart Disease

Intervention(s): Oats or Oat Fibre

Status: UNKNOWN

Enrollment (expected or actual): 1

Allocation:

Sponsor: University of Toronto

Principal Investigator: John Sievenpiper, Associate Professor

Completion Date (primary or actual): 2024-12-01

CT.gov Identifier: NCT05171283

Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids

The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal processing assessed by EEG and fMRI.

First Posted: 2015-07-01

Condition(s): Healthy, Modeling Psychosis

Intervention(s): delta-9-tetrahydrocannabinol, Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Central Institute of Mental Health, Mannheim

Principal Investigator: F Markus Leweke, Prof. Dr. F. Markus Leweke

Completion Date (primary or actual): 2015-08

CT.gov Identifier: NCT02487381

CBT-I for Cannabis Use

The purpose of this study is to investigate the efficacy of a group-based behavioral sleep intervention, and the incremental benefit provided by an adjunct sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans.

First Posted: 2014-04-02

Condition(s): Marijuana Abuse, Sleep Initiation and Maintenance Disorders

Intervention(s): Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA), Desensitization Treatment for Insomnia

Status: TERMINATED

Enrollment (expected or actual): 111

Allocation: RANDOMIZED

Sponsor: VA Office of Research and Development

Principal Investigator:

Completion Date (primary or actual): 2017-03-24

CT.gov Identifier: NCT02102230

PF 06412562 in Subjects With Advanced Stage Parkinson's Disease

The purpose of this study is to test the safety and tolerability of the investigational drug PF-06412562 compared to the current medical standard of care medication for Parkinson's disease, carbidopa/levodopa. This research also is being done to find out if the investigational drug PF-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of Parkinson's disease. In this study, PF06412562 is 'investigational,' which means that it is experimental and has not been approved by the US Food and Drug Administration (FDA), but can be used in clinical research studies such as this one.

First Posted: 2018-09-11

Condition(s): Parkinson Disease

Intervention(s): PF-06412562, Standard of Care Placebo

Status: COMPLETED

Enrollment (expected or actual): 8

Allocation: RANDOMIZED

Sponsor: Milton S. Hershey Medical Center

Principal Investigator: Xuemei Huang, MD, PhD, Professor, Department of Neurology

Completion Date (primary or actual): 2019-04-21

CT.gov Identifier: NCT03665454

Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers

It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers. Objectives are to determine: 1. the maximal tolerated dose of SC ND-0612 2. the steady state plasma concentration of LD and CD following SC ND-0612 administration. Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.

First Posted: 2011-12-06

Condition(s): Parkinson's Disease

Intervention(s): ND0612, Placebo

Status: COMPLETED

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: NeuroDerm Ltd.

Principal Investigator:

Completion Date (primary or actual): 2013-06-13

CT.gov Identifier: NCT01486628

Grass Sensitisation and Allergic Rhinitis in Thai Patients

Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of grass or weed are different in various part of the world. The allergens from grass and weed has never been studied in Thailand. This study will find the major allergen from Bermuda grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In addition, the investigators will study about the cross-reactivity among these group of allergen.

First Posted: 2012-09-17

Condition(s): Allergy to Grass Pollen, Allergic Rhinitis Due to Weed Pollens

Intervention(s): Immunoblot

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation:

Sponsor: Mahidol University

Principal Investigator: Punchama Pacharn, Principal investigator

Completion Date (primary or actual): 2015-10

CT.gov Identifier: NCT01686022

Cannabis Oil and Radiation Therapy for the Management of Pain

In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Furthermore, the investigators will assess the effect of medical cannabis oil on health-related quality of life and symptoms that are frequently associated with metastatic cancers including fatigue, anxiety, depression, insomnia and decreased appetite. The safety profile of medical cannabis oil with respect to prolonged use of more than two weeks of administration, concomitant medication use and palliative RT will also be examined.

First Posted: 2018-12-04

Condition(s): Metastatic Prostate Cancer, Lung Cancer, Breast Cancer

Intervention(s): Active PPP005, Radiotherapy

Status: TERMINATED

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Tetra Bio-Pharma

Principal Investigator:

Completion Date (primary or actual): 2018-11-30

CT.gov Identifier: NCT03763851

The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions

Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required. The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.

First Posted: 2013-06-17

Condition(s): Allergic Rhinitis, Asthma, Allergic Conjunctivitis

Intervention(s): Allergen(Tree, Grass, Weeds)

Status: UNKNOWN

Enrollment (expected or actual): 245

Allocation: RANDOMIZED

Sponsor: University Hospitals Cleveland Medical Center

Principal Investigator: Devi Jhaveri, Principal Investigator

Completion Date (primary or actual): 2014-04

CT.gov Identifier: NCT01878929

A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury

A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.

First Posted: 2012-05-25

Condition(s): Pain

Intervention(s): GW-1000-02, Placebo

Status: COMPLETED

Enrollment (expected or actual): 116

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2005-01

CT.gov Identifier: NCT01606202

Cannabidiol to Reduce Anxiety Reactivity

This study seeks to understand how cannabidiol (CBD) - a non-intoxicating chemical compound obtained from the Cannabis sativa plant - affects biological and stress-related responses that are believed to underlie anxiety disorders. This study will evaluate the effects of different doses of CBD on blood plasma levels of anandamide (a molecule in the brain that has been shown to help regulate stress responses; primary biological signature) and anxiety reactivity to a standardized stress task (secondary target) in an acute (4-day) dosing study (i.e., when steady state CBD levels have been reached). Approximately 60 subjects with social anxiety disorder (SAD), ages 18-70, will participate in this study. They will be assigned by chance to receive one of two doses of CBD (150 mg BID or 450 mg BID administered in two divided doses daily) or placebo (which resembles the study drug but has no active ingredients) BID for 3 days and on the morning of day 4. Knowledge gained from this study will help determine the therapeutic potential of CBD for anxiety.

First Posted: 2023-04-21

Condition(s): Social Anxiety, Social Anxiety Disorder

Intervention(s): Cannabidiol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 63

Allocation: RANDOMIZED

Sponsor: University of California, San Diego

Principal Investigator: Charles Taylor, Associate Professor

Completion Date (primary or actual): 2024-08-20

CT.gov Identifier: NCT05823753

Study of Dronabinol Treatment for Depression and/or Anxiety in Older Patients

This is an observational study evaluating the safety and efficacy of dronabinol for the treatment of anxiety and/or depression in older adults. Participants who are prescribed dronabinol as part of a voluntary inpatient stay in McLean's Division of Geriatric Psychiatry will be interviewed about their mood and cognition on a weekly basis while on dronabinol.

First Posted: 2017-12-12

Condition(s): Depression, Anxiety

Intervention(s):

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation:

Sponsor: Mclean Hospital

Principal Investigator: Brent Forester, Director, Geriatric Psychiatry Research Program and Geriatric Mood Disorders Research Program

Completion Date (primary or actual): 2018-10-01

CT.gov Identifier: NCT03369639

Antihistamines, Amantadine and Evolution of COVID-19

The rates of symptomatic COVID19 infection, hospital admission among COVID19 cases and survival would be quantified in patiens chronically treated with antihistamines or amantadine, with the aim of determining the role of antihistamines and amantadine in the evolution of COVID19.

First Posted: 2022-08-17

Condition(s): COVID-19

Intervention(s): Antihistamine, Amantadine

Status: RECRUITING

Enrollment (expected or actual): 140660

Allocation:

Sponsor: Consorci Sanitari de Terrassa

Principal Investigator: Anna Puigdellívol-Sánchez, Principal Investigator

Completion Date (primary or actual): 2028-02-24

CT.gov Identifier: NCT05504057

Ph1 Marinol Interaction Study - Part 1 - 1

The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.

First Posted: 2007-02-21

Condition(s): Marijuana Dependence

Intervention(s): Dronabinol

Status: TERMINATED

Enrollment (expected or actual): 6

Allocation: NON_RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2007-03

CT.gov Identifier: NCT00438139

L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults

Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional problems in patients with LLD. Similarly, decreased walking speed is associated with depression and carries additional risk for falls, hospitalization, and death. Available evidence suggests that declining functionality in the brain's dopamine system contributes to age-related cognitive and motor slowing. The central hypothesis of this study is that by enhancing dopamine functioning in the brain and improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms in older adults.

First Posted: 2018-12-03

Condition(s): Major Depressive Disorder, Dysthymia, Depression

Intervention(s): L-DOPA, Placebo Oral Tablet

Status: TERMINATED

Enrollment (expected or actual): 51

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Bret Rutherford, Associate Professor of Clinical Psychiatry

Completion Date (primary or actual): 2021-09-08

CT.gov Identifier: NCT03761030

Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to study the efficacy and safety of co-micronised palmithoylethanolamide/polydatin in pediatric patients (\> 10 years) with Irritable bowel syndrome (IBS)

First Posted: 2023-05-22

Condition(s): Irritable Bowel Syndrome

Intervention(s): palmithoylethanolamide/polydatin, placebo

Status: UNKNOWN

Enrollment (expected or actual): 70

Allocation: RANDOMIZED

Sponsor: University of Roma La Sapienza

Principal Investigator: Prof. Giovanni Di Nardo, Professor

Completion Date (primary or actual): 2024-04-19

CT.gov Identifier: NCT05867693

A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066

This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

First Posted: 2010-05-26

Condition(s): Parkinson's Disease

Intervention(s): IPX066, CLE

Status: COMPLETED

Enrollment (expected or actual): 110

Allocation: RANDOMIZED

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): 2012-01

CT.gov Identifier: NCT01130493

Comparison Between Different Techniques in Difficult CBD Cannulation

This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation.

First Posted: 2024-03-18

Condition(s): ERCP, Difficult CBD Cannulation

Intervention(s): DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation

Status: COMPLETED

Enrollment (expected or actual): 150

Allocation: RANDOMIZED

Sponsor: Menoufia University

Principal Investigator: Ahmed El Said Salam, Dr

Completion Date (primary or actual): 2023-11-20

CT.gov Identifier: NCT06315647

Research on Translational Outcomes of Alcohol (Project RETRO)

The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.

First Posted: 2021-02-08

Condition(s): Alcohol Drinking

Intervention(s): Carbidopa Levodopa, Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Brittney Hultgren, Acting Assistant Professor Department of Psychiatry and Behavioral Sciences

Completion Date (primary or actual): 2023-08

CT.gov Identifier: NCT04742348

Safety of Co-Administered CHI-554 and Alcohol

This is a Phase 1, randomized, double-blind study to assess the safety, tolerability, and effects of CHI-554 when co-administered with alcohol.

First Posted: 2022-04-07

Condition(s): Healthy Adults

Intervention(s): CBD oil, CBD oil, Placebo

Status: COMPLETED

Enrollment (expected or actual): 29

Allocation: RANDOMIZED

Sponsor: Auburn University

Principal Investigator: Sara K Blaine, Assistant Professor

Completion Date (primary or actual): 2023-03-31

CT.gov Identifier: NCT05317507

Cannabis Reduction and Functional Outcomes

This study evaluates the effects of cannabis use reduction among adults diagnosed with cannabis use disorder (CUD). Participants will undergo an 8-week intervention combining motivational interviewing, computerized cognitive behavioral therapy (CBT4CBT), and financial incentives for reduction in urinary cannabinoids. The study aims to assess improvements in cannabis-related problems, sleep, cognitive performance, CUD severity, and quality of life.

First Posted: 2025-10-20

Condition(s): Cannabis Use Disorder

Intervention(s): CBT4CBT (Computerized Cognitive Behavioral Therapy), Motivational Interviewing, Contingency Management

Status: RECRUITING

Enrollment (expected or actual): 176

Allocation: NA

Sponsor: Medical University of South Carolina

Principal Investigator: Rachel Tomko, Associate Professor-Faculty

Completion Date (primary or actual): 2030-01-30

CT.gov Identifier: NCT07218471

THC Titration of High-Potency Cannabis Concentrates

High-potency cannabis use is associated with public health risks, such as cannabis use disorder, psychotic disorders, and impaired cognition. Legal markets in the US and Canada are geared towards the commercialization of high-tetrahydrocannabinol (THC) products, including concentrates as high as 90-95%. The cannabis industry has resisted regulation of higher-potency products claiming that cannabis consumers naturally self-titrate their use, but the limited evidence to date suggests that even though consumers may use less cannabis as potency rises, consuming higher potency products still leads to greater THC consumption. The investigators will use a randomized crossover trial to evaluate the ability of 36 regular cannabis consumers (18 females and 18 males) to self-titrate the THC dose when vaping concentrates to achieve the desired psychoactive effects. The investigators will also characterize and compare the subjective, cognitive, physiological, and pharmacokinetic effects between cannabis concentrates of different potencies (30%, 60%, and 90% THC). Working with US scientists, the setting of this study will be Toronto, Canada, in the context of federal legalization of cannabis, unique access to cannabis products not available in the US for research purposes, and an encouraging regulatory environment. The investigators will test commercial products that are representative of the THC ranges available in the legal market. Aim 1: To evaluate the ability of regular cannabis consumers to self-titrate their THC dose when vaping concentrates of different potencies. The investigators will compare markers of titration (biological: THC blood levels; behavioral: inhalation topography; subjective: self-reported levels of intoxication) over a range of potencies for a comprehensive characterization of titration practice. The investigators hypothesize that participants will be able to partially but not proportionally reduce THC intake with increase in THC potency. In other words, the investigators anticipate that the proportional decrease in blood THC levels will be lower than the proportional increase in THC concentrations. Aim 2: To compare the cognitive impairment, physiological effects, and addiction liability of consuming lower versus higher THC potency concentrates. The investigators hypothesize that cognitive impairment and physiological effects will be less pronounced with lower-THC concentrates in a dose-response fashion. The investigators will also explore differences in addiction liability between potencies as higher THC concentrations may result in greater dysphoric reactions. These acute effects may be related to long term harms such as accidents, CVD events, and CUD. Exploratory Aim: To explore sex differences in titration efficiency, blood THC concentrations, cognitive impairment, physiological effects, and addiction liability. The investigators propose to analyze sex differences in our primary and secondary outcomes (e.g., whether females will be able to titrate more efficiently than males). This experimental evidence will provide data on the potential acute harms related to concentrates and inform policy decisions on the need to decrease access and/or prevent their initiation and implement information and education campaigns to increase awareness on the risks of using them.

First Posted: 2025-08-06

Condition(s): THC

Intervention(s): Cannabis (30% THC Concentrate), Cannabis (60% THC Concentrate), Cannabis (90% THC Concentrate)

Status: RECRUITING

Enrollment (expected or actual): 48

Allocation: RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2028-09-30

CT.gov Identifier: NCT07105449

Combined Alcohol and Cannabis Effects on Skills of Young Drivers

Alcohol and cannabis are the two most widely used substances of abuse in the world and are the psychoactive substances most often found in seriously and fatally injured drivers. In a recent study, it was observed that individuals who reported both driving under the influence of alcohol (DUIA) and the influence of cannabis (DUIC) experienced collision risk that was nearly 4 times that of individuals who reported driving after using only one of these drugs. Recent research in the United States and Canada indicates that the prevalence of DUIC among young drivers of high school and university age, and young adults is similar to, or higher than, the prevalence of DUIA. This is a serious public health issue, since motor vehicle collisions are the leading cause of death in this age group. Given the frequency with which alcohol and cannabis are consumed together, it is important to understand their combined effects on driver behaviour. The current study will examine the acute effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Following an eligibility screening and practice session, a total of 70 participants aged 19 to 29 years will each complete 4 experimental sessions. During each session, participants will drink alcohol or placebo alcohol and smoke an active or placebo cannabis cigarette. The effects of alcohol and cannabis on the performance of driving-related skills will be assessed using a high-fidelity driving simulator. Cognitive, psychomotor, and mood effects will also be assessed.

First Posted: 2017-04-10

Condition(s): Psychomotor Impairment

Intervention(s): alcohol, placebo alcohol, delta 9 tetrahydrocannabinol, placebo delta 9 tetrahydrocannabinol

Status: COMPLETED

Enrollment (expected or actual): 49

Allocation: RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator: Christine Wickens, Independent Scientist, Institute for Mental Health Policy Research

Completion Date (primary or actual): 2020-01-17

CT.gov Identifier: NCT03106363

Cannabinoid Control of Fear Extinction Neural Circuits in Humans

The goal of the current proposal is to investigate the effects of a cannabinoid drug on the memory of extinguished fear in humans and the brain circuitry important for the recall of extinction learning. The investigators findings will translate previous discoveries from animal studies to humans and increase their understanding of the neurobiological mechanisms supporting retention of extinction memory. This proof-of-concept study is a critical translational first step towards the development of cannabinoid modulators as an adjunctive strategy to exposure-based therapies to augment extinction learning and prevent the return of fear memories in patients with post-traumatic stress and other anxiety disorders.

First Posted: 2015-06-16

Condition(s): Healthy Participants

Intervention(s): Dronabinol, Placebo

Status: COMPLETED

Enrollment (expected or actual): 85

Allocation: RANDOMIZED

Sponsor: University of Illinois at Chicago

Principal Investigator: K. Luan Phan, MD, Professor

Completion Date (primary or actual): 2014-07

CT.gov Identifier: NCT02472847

A Double-Blind Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epilepsy

The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only). Primary end point(s): Rate of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).

First Posted: 2016-05-26

Condition(s): Epilepsy

Intervention(s): Cannabidiol, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 126

Allocation: RANDOMIZED

Sponsor: Antonio Waldo Zuardi

Principal Investigator: Antonio Waldo Zuardi, MD, PhD, Professor

Completion Date (primary or actual): 2024-09-25

CT.gov Identifier: NCT02783092

Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma

Itching is one of the common symptoms found in patients with scleroderma, with a prevalence of about 42-62%, and it often occurs in the early stages of the disease. The mechanisms of itching are still unclear, and current treatments have not yet shown any clear efficacy in alleviating itching caused by scleroderma. Hemp extract has previously been used to treat itching in chronic skin diseases. Besides its antipruritic (anti-itch) effect, hemp extract also possesses anti-inflammatory properties, increases skin moisture, and helps repair the skin, all without psychoactive effects. Studies have investigated the benefits of hemp extract in the form of a topical cream with concentrations ranging from 1-5% for the treatment of various skin diseases such as psoriasis, eczema, and the management of fingertip ulcers in scleroderma patients. The results showed that a 1% hemp extract cream relieved itching in eczema and at the same concentration also helped heal fingertip ulcers in scleroderma patients. However, to date, there has been no clear study on the effectiveness of hemp extract in cream or lotion form for treating itching in scleroderma patients. Additionally, there is currently no standard guideline for the management of itching in scleroderma. Generally, 10% urea cream is commonly used to increase skin moisture and alleviate itching, but there has been no prior study on its efficacy specifically for itch relief. Therefore, this study aims to evaluate the efficacy of a 1% hemp extract combined with 10% urea in lotion form compared to a lotion containing only 10% urea (without hemp extract) in relieving itching, increasing skin moisture, and reducing sleep disturbances caused by itching in scleroderma patients, as well as assessing any potential side effects.

First Posted: 2025-11-24

Condition(s): Mediciine, Systemic Sclerosis (SSc), Intervention Study

Intervention(s): 10% urea lotion plus 1% cannabidiol, Control

Status: RECRUITING

Enrollment (expected or actual): 36

Allocation: RANDOMIZED

Sponsor: Khon Kaen University

Principal Investigator: Chingching Foocharoen, Principle investigator

Completion Date (primary or actual): 2028-12

CT.gov Identifier: NCT07245238

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.

First Posted: 2018-09-21

Condition(s): Pain, Abuse, Drug

Intervention(s): Oxycodone, Cannabis (THC:CBD = ~ 1:0), Cannabis (THC:CBD = ~ 0:1), Cannabis (THC:CBD = ~ 1:1), Placebo

Status: COMPLETED

Enrollment (expected or actual): 26

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Caroline A. Arout, Ph.D., Research Scientist

Completion Date (primary or actual): 2022-12-06

CT.gov Identifier: NCT03679949

5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers

The primary objective of the study was to evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray.

First Posted: 2017-06-28

Condition(s): Healthy Volunteers

Intervention(s): PNL-THC:CBD soft gelatin capsule, Sativex, CBD hard capsule dose 1, P-PNL-THC:CBD soft gelatin capsule, CBD hard capsule dose 2

Status: COMPLETED

Enrollment (expected or actual): 15

Allocation: RANDOMIZED

Sponsor: PhytoTech Therapeutics, Ltd.

Principal Investigator:

Completion Date (primary or actual): 2016-06-06

CT.gov Identifier: NCT03201835

Effects of Core Exercise on Posture and Trunk Endurance in Sedentary Males

Increased sedentary lifestyles due to modern technological advancements have negatively impacted posture and trunk stability. Proper posture relies on balanced dorsal and ventral muscles, trunk stabilization, and joint flexibility. Deviations in these factors may lead to postural abnormalities and, over time, structural deformities. Early detection and intervention through corrective exercises can mitigate these issues. Various measurement techniques, including 2D and 3D scanning, allow for objective posture assessment. Core stabilization exercises have been shown to influence spinal alignment and muscle endurance, improving postural control. However, limited research focuses on young adult males. This study aimed to evaluate the effects of an 8-week core exercise program on posture and trunk endurance in sedentary university students. A randomized controlled trial was conducted on male university students at the University of Novi Sad, Serbia. Participants were recruited through an open call, and those with prior musculoskeletal, neurological, or metabolic conditions were excluded. The final sample included 138 participants divided into an experimental group (EG) and a control group (CG). The EG followed an 8-week core stabilization program, while the CG did not receive any intervention. Postural assessments were conducted using CONTEMPLAS TEMPLO software with 2D and 3D analysis protocols. Measurements included the Fröner Posture Index (PI) and the Kyphosis-Inclination-Lordosis (KIL) scheme, evaluating thoracic kyphosis, cervico-lumbar, and lumbar-gluteal angles. Trunk endurance was assessed through the Sorensen Back Extensor Test (BET), the Abdominal Flexor Endurance Test (FET), and the Double Leg Lowering Test (DLL). The intervention program consisted of progressive core stabilization exercises, increasing in difficulty from basic planks to exercises on unstable surfaces. The experimental group underwent structured core training three times a week for eight weeks. The program included exercises to enhance mobility and strengthen the neck, shoulders, pelvis, and hips, with a focus on stabilizing the spine through anti-flexion, anti-extension, and anti-rotation movements. Exercises progressed from static planks to dynamic and unstable surface training. The control group did not participate in any structured physical activity.

First Posted: 2025-03-14

Condition(s): Posture, Trunk Muscle Endurance

Intervention(s): Core exercise

Status: COMPLETED

Enrollment (expected or actual): 230

Allocation: RANDOMIZED

Sponsor: University of Novi Sad

Principal Investigator: Dragan Marinkovic, Principal investigator

Completion Date (primary or actual): 2019-06-20

CT.gov Identifier: NCT06877806

Bone Marrow Transplant With Abatacept for Non-Malignant Diseases

This is a single arm, phase I study to assess the tolerability of abatacept when combined with cyclosporine and mycophenolate mofetil as graft versus host disease prophylaxis in children undergoing unrelated hematopoietic stem cell transplant for serious non-malignant diseases as well as to assess the immunological effects of abatacept. Participants will be followed for 2 years.

First Posted: 2013-08-07

Condition(s): Hurler Syndrome, Fanconi Anemia, Glanzmann Thrombasthenia, Wiskott-Aldrich Syndrome, Chronic Granulomatous Disease, Severe Congenital Neutropenia, Leukocyte Adhesion Deficiency, Shwachman-Diamond Syndrome, Diamond-Blackfan Anemia, Dyskeratosis-congenita, Chediak-Higashi Syndrome, Severe Aplastic Anemia, Thalassemia Major, Hemophagocytic Lymphohistiocytosis, Sickle Cell Disease

Intervention(s): Abatacept

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: Emory University

Principal Investigator: John Horan, Associate Professor

Completion Date (primary or actual): 2019-09-19

CT.gov Identifier: NCT01917708

Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation

Background: * The therapeutic modalities of cannabis have received more research attention recently with the discovery of its ability to stimulate appetite and to provide pain and nausea relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases. Sativex(Registered Trademark), an experimental drug derived from the marijuana plant, contains tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which affect brain activity. Sativex(Registered Trademark) is being tested to determine how and to what extent it affects brain activity. * Functional magnetic resonance imaging (fMRI) uses magnetic waves to study brain activity. Researchers are interested in using fMRI to study how Sativex(Registered Trademark) affects regional brain activity, including thinking abilities and behavior. Objectives: * To study changes in regional brain activity produced by Sativex(Registered Trademark) compared with THC and placebo. * To determine how Sativex(Registered Trademark) is processed by the body. Eligibility: \- Individuals between 18 and 45 years of age who are either current users of cannabis (less than daily) or healthy volunteers who do not use cannabis. Design: * The study will involve one training session and five testing sessions on separate days. * At every session, subjects will receive either THC or placebo capsules and either Sativex(Registered Trademark) or placebo spray. * Participants will complete a training session in a mock fMRI scanner to adapt to the fMRI scanning environment. In the training session, participants will practice the tests that will track thinking ability, attention, working memory, and other cognitive tasks. * Participants will have five fMRI scanning sessions with the tests they have practiced previously, and will provide blood, urine, and saliva samples as required by the researchers. Participants will be discharged approximately 12 hours after they arrive for the study sessions....

First Posted: 2009-12-23

Condition(s): Cannabis, Dependence, Cannabis Abuse, Pharmacokinetics, fMRI

Intervention(s): Sativex(Registered Trademark), THC

Status: COMPLETED

Enrollment (expected or actual): 108

Allocation: RANDOMIZED

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

Completion Date (primary or actual): 2011-12-12

CT.gov Identifier: NCT01037608

Study on Regulated Cannabis Sales in Pharmacies

Though regulated cannabis sales are increasing, little is known about the individual health effects of cannabis regulation. Data from countries with a regulated market can be used to test the effect of regulation on the price of cannabis in the illicit market, and to explore its effect on social and health outcomes at the societal level, but strength of evidence for individual health and social outcomes is more limited because it must be aggregated on a state or country level. Data on individual and social outcomes should include baseline measurements before and outcome measurements after regulations changed. In this context, randomized-controlled trials are the least biased source of data on the effects of interventions. The SCRIPT study aims to investigate the individual health and social impact on recreational cannabis users who are allowed to purchase authorized, regulated cannabis from Swiss pharmacies compared to users who buy cannabis on the illicit market. Participants are randomly allocated in one of the two groups and followed-up for 6 months. After 6 months, all participants are allowed to participate in the intervention and the cohort is followed up for another 18 months. The intervention includes various offers: Participants can choose between cannabis sorts and delivery methods, and they are encouraged to shift from smoking cannabis to vaping cannabis-containing e-liquids, vaporizing cannabis blossoms or using oral cannabis. Vaping / vaporizing electronic devices are also recommended. At the same time, pharmacists offer opportunistic smoking cessation and problematic cannabis, alcohol use and further drug use counseling that conforms to motivational interviewing principles. The SCRIPT study adheres to rigorous quality criteria for the production and storage of regulated cannabis products. Only vaping / vaporizing electronic devices which are validated to reduce exposure to toxicants compared to cannabis smoking are recommended.

First Posted: 2023-11-07

Condition(s): Marijuana Smoking, Cannabis, Cannabis Use

Intervention(s): Regulated cannabis from authorized pharmacies, Cannabis from the illicit market

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 1177

Allocation: RANDOMIZED

Sponsor: University of Bern

Principal Investigator:

Completion Date (primary or actual): 2029-12-31

CT.gov Identifier: NCT06120855

Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization. The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.

First Posted: 2020-07-08

Condition(s): Healthy Volonteers

Intervention(s): PPP001

Status: COMPLETED

Enrollment (expected or actual): 12

Allocation: NA

Sponsor: Tetra Bio-Pharma

Principal Investigator:

Completion Date (primary or actual): 2018-11-24

CT.gov Identifier: NCT04461756

Duckweed Intake Study

The study aims to study the impact of frequent intake of 150-180 gram duckweed on gastrointestinal complaints and several other health related biomarkers. The study has a randomised parallel design. Two different treatments will be evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with control/spinach meals. At the start and at the end of the intervention we will collect a blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.

First Posted: 2018-09-19

Condition(s): Gastrointestinal Complication

Intervention(s): Duckweed, Spinach

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: RANDOMIZED

Sponsor: Wageningen University and Research

Principal Investigator: Diederik Esser, project leader clinical trials

Completion Date (primary or actual): 2018-10-15

CT.gov Identifier: NCT03677583

Skills for Talking About Cannabis for Families of Young Adults With Psychosis

The objectives of this research is to (1) create a family intervention and provider manual to train family members of young people with psychosis (YP-P) who are heavy cannabis users new communication skills to motivate change in the YP-P's cannabis use, (2) pre-test the intervention with 10 family member participants and adapt the intervention based on their recommendations, and (3) evaluate the feasibility and acceptability of the intervention in a randomized pilot trial (n=40). The investigators anticipate that the intervention will improve family participants' communication skills, decrease expressed emotion and caregiver burden. The investigators anticipate that improvements in communication skills, expressed emotion and caregiver burden will lead to decreases in the cannabis use of their YP-P.

First Posted: 2025-05-08

Condition(s): Caregiver Burden, Cannabis Use, Expressed Emotion, Communications Skills

Intervention(s): Cannabis Conversation Skills for Families (CCSF)

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Denise Walker, Research Professor

Completion Date (primary or actual): 2027-07

CT.gov Identifier: NCT06961877

Chronic Cannabis Smoking, Oxidative Stress and the Pulmonary Innate Immune Response

This study plans to evaluate the effects of chronic cannabis smoking on lung health by evaluating its effects on pulmonary health, lung physiology and alveolar macrophage function.

First Posted: 2015-06-24

Condition(s): Cannabis Smoking, Oxidative Stress

Intervention(s): Bronchoscopy, Chest X-ray, Venipuncture, Intravenous Catheter

Status: RECRUITING

Enrollment (expected or actual): 100

Allocation:

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): 2027-07

CT.gov Identifier: NCT02480283

PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis

We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety

First Posted: 2023-09-26

Condition(s): Cigarette Smoking-Related Carcinoma

Intervention(s): Vape device, Joint, Marijuana via vape device, Marijuana via joint

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Roswell Park Cancer Institute

Principal Investigator:

Completion Date (primary or actual): 2027-09-15

CT.gov Identifier: NCT06055231

Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations

The study is a multicenter, randomized, open-label, active-controlled, Phase II clinical study. The aim of this trial is to evaluated the pharmacokinetics, pharmacodynamics,efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease Patients With Motor Fluctuations.

First Posted: 2024-09-26

Condition(s): Parkinson's Disease

Intervention(s): HRG2010(I), HRG2010(II), Sustained-release Carbidopa/Levodopa

Status: COMPLETED

Enrollment (expected or actual): 61

Allocation: RANDOMIZED

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Principal Investigator:

Completion Date (primary or actual): 2024-03-04

CT.gov Identifier: NCT06614153

Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

First Posted: 2017-01-02

Condition(s): PostTraumatic Stress Disorder

Intervention(s): Placebo Oral Capsule, Dronabinol Cap 5 milligrams (MG), Dronabinol Cap 10 milligrams (MG)

Status: COMPLETED

Enrollment (expected or actual): 46

Allocation: RANDOMIZED

Sponsor: Wayne State University

Principal Investigator: Christine Rabinak, PhD, Assistant Professor

Completion Date (primary or actual): 2019-12-31

CT.gov Identifier: NCT03008005

In Vitro Studies on Pharmacological Regulation and Genetic Risk Factors of Peripheral Human Nociceptors

This protocol is for a number of in vitro studies using human surgical biopsies and evaluating the pharmacology and genetics of human nociceptors ("pain detecting") neurons

First Posted: 2005-09-22

Condition(s): Pain

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 2007

Allocation:

Sponsor: The University of Texas Health Science Center at San Antonio

Principal Investigator: Kenneth Hargreaves, Chair, Dept. of Endodontics

Completion Date (primary or actual): 2019-05-19

CT.gov Identifier: NCT00223366

Detection of Cannabis Impairment With an Eye Tracker

Cannabis is one of the widely used psychoactive substances in the world. With increasing legalization, the prevalence of driving under the influence of cannabis will undoubtedly rise. At present, roadside detection of cannabis intoxication is largely dependent on drug recognition experts who rely on changes in eye movements when impaired. In this regard, use of eye trackers can help to detect impairment in drivers. The purpose of the present study is to determine the feasibility of the use of eye trackers in detecting impairment in participants who smoked a cannabis cigarette.

First Posted: 2019-01-23

Condition(s): Cannabis Intoxication

Intervention(s): Cannabis Sativa

Status: COMPLETED

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2019-11-15

CT.gov Identifier: NCT03813602

Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease

Our primary objective is to assess whether inhaling vaporized cannabis ameliorates chronic pain in patients with sickle cell disease (SCD). As these patients will all be on chronic opioid analgesics, the investigators will also assess the possible synergistic affect between inhaled cannabis and opioids. The investigators will also assess the clinical safety of the concomitant use of cannabinoids and these opioids in patients with SCD by monitoring the short-term side effects associated with combined therapy. Finally, the investigators will evaluate the short-term effects of inhaled cannabis on markers of inflammation and disease progression in patients with SCD. Hypotheses are as follows: 1. Inhaled cannabis will significantly reduce chronic pain in patients with SCD. 2. Inhaled cannabis will significantly alter the short-term side effects experienced by patients who take opioids for SCD. 3. Inhaled cannabis will significantly alter markers of inflammation and disease progression in patients with SCD compared to placebo.

First Posted: 2013-01-18

Condition(s): Sickle Cell Disease

Intervention(s): Cannabis

Status: COMPLETED

Enrollment (expected or actual): 27

Allocation: RANDOMIZED

Sponsor: University of California, San Francisco

Principal Investigator:

Completion Date (primary or actual): 2017-05-19

CT.gov Identifier: NCT01771731

A Study Testing the Safety and Effects of Single Doses of S1-221 in Healthy Volunteers

The purpose of this Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of single ascending doses of S1-221 administered orally to healthy adult participants. S1-221 is a liquid containing cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC). Acute subjective effects will be evaluated as a pharmacodynamic (PD) assessment and changes in plasma endocannabinoid levels will be assessed as an exploratory objective. Data from this study will be used to select doses to be evaluated in subsequent studies to investigate the efficacy and safety of S1-221 in migraine patients.

First Posted: 2025-08-28

Condition(s): Healthy Participants

Intervention(s): S1-221, Placebo, THC

Status: COMPLETED

Enrollment (expected or actual): 64

Allocation: RANDOMIZED

Sponsor: Delphian Therapeutics Australia Pty, Ltd

Principal Investigator:

Completion Date (primary or actual): 2026-08-17

CT.gov Identifier: NCT07146945

Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals

Synthetic cannabinoids (SCs) are new human-made mind-altering chemicals which are similar to chemicals found in the marijuana plant; they are recent to be used recreationally, especially by young adults. This new generation of novel cannabinoid compounds have been developed to avoid drug control laws and routine cannabinoid blood tests

First Posted: 2019-03-07

Condition(s): Epidemiologic Data of Some Synthetic Cannibinoids Toxicity in Patients Presenting at Assiut University Hospital, Psychiatric Hospital of Ministry of Health), Proportion of Acute and Chronic Abusers of Synthetic Cannibinoids Among Cases of Illicit Drugs Abuser in Studied Sites

Intervention(s): causes of abuse synthetic cannibinoids

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation:

Sponsor: Assiut University

Principal Investigator: MKMAbdelrahim, assistant lecturer

Completion Date (primary or actual): 2021-12-30

CT.gov Identifier: NCT03866941

Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.

First Posted: 2008-03-25

Condition(s): Parkinson's Disease

Intervention(s): Carbidopa/levodopa/entacapone, Immediate release carbidopa/levodopa

Status: TERMINATED

Enrollment (expected or actual): 14

Allocation: RANDOMIZED

Sponsor: Novartis

Principal Investigator:

Completion Date (primary or actual): 2009-05

CT.gov Identifier: NCT00642356

Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim

Subjects will participate in a 4-visit study protocol at the National Advanced Driving Simulator, part of the University of Iowa, in which they will be asked to complete assorted questionnaires, computerized cognitive tasks, and a simulator drive. Subjects will be administered 0.75 mg alprazolam (Xanax) or placebo and 500 mg vaporized cannabis (6.18% THC / \<0.025% CBD) or placebo (0% THC / 0% CBD). The primary objective of this study is to validate the Drug Impaired Driving Scenario (DIDS) using the CRCDS-2 driving simulator by assessing the acute effects of cannabis relative to placebo on simulated driving performance. Assay sensitivity will be demonstrated by the significant effect of 0.75 mg alprazolam (active comparator) on driving and cognitive endpoints.

First Posted: 2021-07-21

Condition(s): Driving Behavior, Driving Under the Influence

Intervention(s): Placebo (Lactose) Capsule, 0.75 mg Alprazolam Capsule, Cannabis (6.18% THC / <0.025% CBD), Cannabis (0%/ THC / 0% CBD)

Status: COMPLETED

Enrollment (expected or actual): 13

Allocation: RANDOMIZED

Sponsor: Timothy L. Brown

Principal Investigator: Timothy L. Brown, Director of Drugged Driving Research

Completion Date (primary or actual): 2021-08-21

CT.gov Identifier: NCT04970342

Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)

The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.

First Posted: 2010-03-31

Condition(s): Chronic Obstructive Pulmonary Disease

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 200

Allocation:

Sponsor: The University of Texas Health Science Center, Houston

Principal Investigator: Rosa Estrada Y Martin, Associate Professor - I/M Pulmonary and Critical Care

Completion Date (primary or actual): 2016-12-31

CT.gov Identifier: NCT01096303

Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia

Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too early in the morning, or having unrefreshing sleep. Defined CBD is a capsule composed of highly purified (\>99.9%) hemp-derived cannabidiol (CBD) and terpenes produced as a potential sleep aid for people with insomnia. This product contains no detectable Delta-9-tetrahydrocannabinol (Delta-9-THC). This trial is specifically designed to evaluate the efficacy of Defined CBD on sleep physiology in people with insomnia.

First Posted: 2022-02-10

Condition(s): Insomnia

Intervention(s): Defined CBD, Placebo

Status: COMPLETED

Enrollment (expected or actual): 125

Allocation: RANDOMIZED

Sponsor: Defined Research

Principal Investigator:

Completion Date (primary or actual): 2022-07-02

CT.gov Identifier: NCT05233761

Reducing Cannabis Overuse With Prazosin

Cannabis use disorder (CUD) is a significant and expanding health problem, and no FDA approved treatments are currently available. Persons with posttraumatic stress disorder (PTSD) may use cannabis to help control symptoms. Relief from PTSD insomnia, nightmares, anxiety, and preoccupying thoughts have been reported as troublesome symptoms targeted by cannabis users. Risks from cannabis use by individuals with PTSD have been reported. Chronic use of cannabis can lead to tolerance, requiring increased use for symptom relief, and withdrawal symptoms upon stopping. CUD is more frequent and severe in those with PTSD than those without. Many symptoms of cannabis withdrawal overlap with troubling symptoms of PTSD and thus may be interpreted as a relapse of PTSD symptoms. Those attempting to reduce or stop cannabis use may experience cannabis withdrawal symptoms including insomnia and distressing dreams, anxiety, irritability, and/or excessive sweating that they may misattribute to re-emerging or untreated PTSD symptoms. Excessive brain adrenaline activity is arguably the best-described neurobiological contribution to the pathophysiology of PTSD. Prazosin, a drug that blocks the negative effects of brain adrenaline, has demonstrated effectiveness in robustly reducing PTSD-related nightmares and sleep disturbance in active duty Servicemembers and recently discharged combat Veterans in most, but not all, clinical trials, as well as in civilians with non-combat trauma. Clinically, the investigators have observed that several patients with PTSD using cannabis to treat insomnia and/or trauma-related nightmares and wanting to reduce their cannabis use were able to achieve reduction or cessation of cannabis use once they were treated with an effective dose of prazosin. Therefore, we have wondered if prazosin may provide sufficient treatment of PTSD symptoms otherwise targeted by cannabis, supporting those individuals' efforts to reduce cannabis use. This open-label pilot study aims to study the feasibility of prazosin as a treatment for CUD in individuals with or without comorbid PTSD, and to evaluate if additional research on a larger scale is warranted.

First Posted: 2021-01-22

Condition(s): Cannabis Dependence, Posttraumatic Stress Disorder, Cannabis Use Disorder

Intervention(s): Prazosin Hydrochloride

Status: COMPLETED

Enrollment (expected or actual): 11

Allocation: NA

Sponsor: VA Puget Sound Health Care System

Principal Investigator: Garth Terry, Assistant Professor, School of Medicine

Completion Date (primary or actual): 2025-06-01

CT.gov Identifier: NCT04721353

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

First Posted: 2012-04-02

Condition(s): Parkinson's Disease

Intervention(s): BIA 9-1067, Entacapone, Placebo, Levodopa, Carbidopa, Benserazide

Status: COMPLETED

Enrollment (expected or actual): 600

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2013-11

CT.gov Identifier: NCT01568073

Effects of Chronic Intake of Cannabis on Contrast Sensitivity

Rates of driving under the influence of cannabis have risen in recent years. Cannabis is involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast sensitivity disorders could originate difficulties to anticipate and avoid collision with objects, especially when objects are in movement. The investigators goal is to examine the effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be compared to standard references. In addition, since smoking cannabis is always associated with tobacco, the investigators will control the effects of tobacco on contrast sensitivity. In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36 no smokers. The investigators will present gratings with different spatial frequencies and the investigators will determine contrast thresholds for static and dynamic (moving) gratings. The investigators predict that cannabis addicts will present abnormal contrast sensitivity especially in case of dynamic presentation of gradings.

First Posted: 2013-02-18

Condition(s): Cannabis Dependence

Intervention(s): electroretinogram, contrast sensitivity tests

Status: COMPLETED

Enrollment (expected or actual): 95

Allocation: NON_RANDOMIZED

Sponsor: University Hospital, Strasbourg, France

Principal Investigator:

Completion Date (primary or actual): 2018-09-10

CT.gov Identifier: NCT01793961

Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)

1\. To assess treatment efficacy with YCJ-01 by changes in the number of epileptic seizures in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex. 2. To assess the safety of the treatment with YCJ-01 in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.

First Posted: 2026-02-11

Condition(s): Tuberous Sclerosis Complex (TSC)

Intervention(s): YCJ-01 Full Spectrum cannbis Extract, Placebo

Status: RECRUITING

Enrollment (expected or actual): 84

Allocation: RANDOMIZED

Sponsor: Oils4Cure

Principal Investigator:

Completion Date (primary or actual): 2027-06

CT.gov Identifier: NCT07403266

Nabilone for Cannabis Dependence: A Pilot Study

Cannabis use disorders are an important public health problem in the United States, but there are no effective medications available to treat these disorders. The investigators intend to test a medication with interesting properties, nabilone, as a treatment for cannabis dependence and to study the relationship of this treatment with the brain using functional MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and the human body, suggesting that nabilone may decrease cannabis withdrawal symptoms while allowing treatment-seeking patients to benefit from behavioral treatments when they are trying to stop using cannabis. The investigators propose to assess the relationship of nabilone, when added to behavioral treatment, on cannabis use patterns in cannabis-dependent patients. The investigators also aim to determine the effects of nabilone on performance on neuropsychological tests and to assess the correlation of neuropsychological performance to brain changes using functional MRI brain scans. The investigators hypothesize that patients receiving nabilone will reduce their use of cannabis more than patients receiving placebo during this 10-week treatment trial.

First Posted: 2011-05-04

Condition(s): Cannabis Dependence, Marijuana Dependence

Intervention(s): Nabilone, Placebo

Status: COMPLETED

Enrollment (expected or actual): 84

Allocation: RANDOMIZED

Sponsor: Mclean Hospital

Principal Investigator: Kevin P. Hill, MD, MHS, Psychiatrist-In-Charge

Completion Date (primary or actual): 2017-06-09

CT.gov Identifier: NCT01347762

Pharmacogenetic Variation: Factors That May Affect the Efficacy and Safety of Medical Marijuana

The primary purpose of this research is to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. The pharmacogenomics test detects DNA variants, which may affect the way drugs work and are metabolized in the body and/or detect potential side effects.

First Posted: 2019-09-10

Condition(s): New York Medical Marijuana Program Qualifying Conditions

Intervention(s): DNA Genotek Oragene 600

Status: COMPLETED

Enrollment (expected or actual): 157

Allocation:

Sponsor: Columbia Care Inc.

Principal Investigator:

Completion Date (primary or actual): 2020-03-30

CT.gov Identifier: NCT04083261

Medical Cannabis for Treating Pain Related to Fibromyalgia

The goal of this interventional study is to learn about the effect of Medicinal Cannabis (Bedrocan®) on Fibromyalgia patients with pain resistant to conventional therapy. The main question the trial aims to answer are: * Is Bedrocan® effective for treating fibromyalgia-related pain in patients resistant to conventional therapy? * Can a low dosage of medical cannabis taken as a decoction reduce fibromyalgic pain? All patients were trained on how to make the decoction: therapy was started with 100 mg/day (1 folder) and increased to 200 mg/day (2 folders) in non-responders.

First Posted: 2023-07-11

Condition(s): Fibromyalgia

Intervention(s): Bedrocan®-type cannabis (22% THC, <1% CBD)

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: NA

Sponsor: Universita degli Studi della Basilicata

Principal Investigator:

Completion Date (primary or actual): 2021-09-30

CT.gov Identifier: NCT05939466

Cannabidiol for the Treatment of Pelvic Pain in Endometriosis (DREAMLAND)

The objective of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabis extract in women with endometriosis who have already undergone hormonal contraceptive treatment and surgery without satisfactory response.

First Posted: 2023-01-04

Condition(s): Endometriosis, Pelvic Pain

Intervention(s): Cannabis Derivatives, Placebo, Hormonal Contraceptive Agents

Status: TERMINATED

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: University of Sao Paulo

Principal Investigator: Omero Benedicto Poli Neto, Prof. Dr.

Completion Date (primary or actual): 2024-11-20

CT.gov Identifier: NCT05670353

Prenatal Exposure Effects Psychophysiology Study

The purpose of the study is to understand the biology and behavior of early mother-infant attachment, and to investigate how it may be affected by prenatal substance exposures. The investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette smoking affect both mother and baby.

First Posted: 2010-06-02

Condition(s): Pregnancy

Intervention(s):

Status: ENROLLING_BY_INVITATION

Enrollment (expected or actual): 150

Allocation:

Sponsor: University of North Carolina, Chapel Hill

Principal Investigator:

Completion Date (primary or actual): 2027-01

CT.gov Identifier: NCT01134770

N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use

Tobacco and cannabis co-use is a common and growing public health problem, especially in states that have legalized cannabis. There are no pharmacologic treatments for co-occurring tobacco and cannabis use. Co-use may make quitting either substance more difficult, given the synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared cues reinforcing co-use. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use.

First Posted: 2020-11-13

Condition(s): Cannabis Use, Tobacco Use Disorder, Drug Use Disorder

Intervention(s): N-Acetyl cysteine, Placebo comparator, Cognitive behavioral therapy (CBT)

Status: COMPLETED

Enrollment (expected or actual): 41

Allocation: RANDOMIZED

Sponsor: Ellen Herbst

Principal Investigator: Ellen Herbst, Principal Investigator

Completion Date (primary or actual): 2025-06-30

CT.gov Identifier: NCT04627922

A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.

First Posted: 2023-05-18

Condition(s): Tuberous Sclerosis Complex Associated Neuropsychiatric Disease

Intervention(s): Cannabidiol Oral Solution [Epidiolex]

Status: COMPLETED

Enrollment (expected or actual): 79

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2026-04-06

CT.gov Identifier: NCT05864846

Using Implementation Intentions to Reduce Cannabis Use

The study will recruit frequent users of cannabis (defined at least fortnightly use) and randomize them either to: (1) form implementation intentions by linking situations in which they are tempted to use cannabis with strategies to avoid using cannabis in those situations by using a volitional help sheet, or (2) to consider the situations in which they are tempted to use cannabis alongside possible strategies to avoid using it as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported cannabis use will be assessed 1 month post-intervention. Predictors of cannabis reduction will also be examined.

First Posted: 2019-02-19

Condition(s): Cannabis Use

Intervention(s): Volitional help sheet

Status: COMPLETED

Enrollment (expected or actual): 311

Allocation: RANDOMIZED

Sponsor: University of Manchester

Principal Investigator: Lynsey Gregg, Principal Investigator

Completion Date (primary or actual): 2020-11-30

CT.gov Identifier: NCT03845842

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

This is a Phase 1b/2a clinical trial to evaluate the safety, tolerability, and efficacy of RLS103 (cannabidiol \[CBD\] inhaled dry powder) to relieve the anxiety induced by a public speaking challenge in adults with social anxiety disorder (SAD). Subject participation will last 4 - 6 weeks. Upon signing an informed consent, all subjects will enter a screening phase lasting up to 3 weeks and including history, physical examination, laboratory tests, ECG, spirometry, and psychological tests. Subjects will undergo a public speaking test after screening tests are performed and eligibility is confirmed. One week after the completion of the public speaking test, subjects will come back for a follow-up visit that will involve a repeat of the safety and psychiatric assessments conducted during screening.

First Posted: 2022-06-23

Condition(s): Social Anxiety Disorder

Intervention(s): Low dose RLS103, High dose RLS103, placebo inhaled dry powder

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Receptor Life Sciences

Principal Investigator:

Completion Date (primary or actual): 2022-11-08

CT.gov Identifier: NCT05429788

Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis

This outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette.

First Posted: 2026-07-10

Condition(s): Cannabis Use, Tobacco, Biomarkers

Intervention(s): Cannabis (THC), Tobacco Cigarette

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: Hannah Harris

Principal Investigator: Hannah Harris, Assistant Professor

Completion Date (primary or actual): 2027-06-01

CT.gov Identifier: NCT07694466

High Potency Cannabis: Acute and Protracted Effects

The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.

First Posted: 2025-03-05

Condition(s): Abuse Cannabis, Pain, Pharmacokinetics

Intervention(s): Placebo Comparator: Placebo, Low dose THC, High dose THC

Status: RECRUITING

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Professor

Completion Date (primary or actual): 2028-07-01

CT.gov Identifier: NCT06859723

Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.

First Posted: 2008-05-12

Condition(s): Pain, Cancer

Intervention(s): Sativex, GW-2000-02

Status: COMPLETED

Enrollment (expected or actual): 43

Allocation: NON_RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2006-09

CT.gov Identifier: NCT00675948

Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or feet due to chemotherapy. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Peripheral neuropathy caused by chemotherapy is called chemotherapy-induced peripheral neuropathy (CIPN). CIPN is commonly seen in patients receiving certain chemotherapy medications and is hard to treat. Medications commonly used to treat CIPN have limited benefits and may cause significant side effects. A small report showed that topical cannabidiol may help treat neuropathy in patients with diabetes. This study is being done to determine if cannabidiol cream can help improve the symptoms of CIPN.

First Posted: 2022-05-24

Condition(s): Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm

Intervention(s): Cannabidiol, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Mayo Clinic

Principal Investigator:

Completion Date (primary or actual): 2023-07-28

CT.gov Identifier: NCT05388058

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

First Posted: 2018-09-07

Condition(s): Bone Metastases, Breast Cancer, Pain

Intervention(s): Syndros

Status: COMPLETED

Enrollment (expected or actual): 14

Allocation: NA

Sponsor: University of Arizona

Principal Investigator:

Completion Date (primary or actual): 2021-04-26

CT.gov Identifier: NCT03661892

Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety

The goal of this clinical trial is to learn if inhaled drug NC-107 works to treat Generalized anxiety disorder in adults. It will also learn about the safety of the drug NC-107. The main questions it aims to answer are: Does the inhaled drug NC-107 decrease the severity of anxiety in participants? What medical problems could participants have when taking drug NC-107? How quickly does NC-107 absorb and get into the blood stream? Researchers will compare drug NC-107 to a placebo (a look-alike substance that contains no drug) to see how effective NC-107 in treating generalized anxiety disorder. Participants will be equal to or above 18 years of age and sign an informed consent. They will answer two questionnaires about anxiety and have vitals taken, as well as blood drawn for laboratory results. If a questionnaire reveals moderate anxiety and all blood work is normal the patient will enter the study. The patient will be instructed on the use of an inhaler, that will deliver the medication via the lung. Two puffs twice daily of NC-107 or placebo will be used during the remainder of the study. Blood will be drawn for peak and trough levels of NC-107. Questionnaires will be completed at each visit.

First Posted: 2024-10-24

Condition(s): Generalized Anxiety Disorder

Intervention(s): Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD, Determine the presence and concentration of CBD in subject's plasma with inhaled CBD

Status: UNKNOWN

Enrollment (expected or actual): 40

Allocation: NON_RANDOMIZED

Sponsor: Trinity Hypertension & Metabolic Research Institute

Principal Investigator: Henry Anthony Punzi, Medical Director

Completion Date (primary or actual): 2025-05-01

CT.gov Identifier: NCT06656806

Opicapone Treatment Initiation Open-Label Study

This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing "off" episodes with motor fluctuations

First Posted: 2021-03-09

Condition(s): Parkinson Disease

Intervention(s): Opicapone

Status: COMPLETED

Enrollment (expected or actual): 239

Allocation:

Sponsor: Neurocrine Biosciences

Principal Investigator:

Completion Date (primary or actual): 2022-08-04

CT.gov Identifier: NCT04787965

Psilocybin in the Treatment of Cannabis Use Disorder: A-Proof-of-Concept Study

Cannabis is the most commonly used psychoactive substance in Canada (Lowry \& Corsi, 2020). A sub-group of cannabis users develop a condition known as Cannabis Use Disorder (CUD), which is defined as a regular pattern of cannabis use that causes performance difficulty at work, school and relationships (Hasin et al., 2013). A review of current treatments available for CUD indicate the lack of a pharmacological and psychological treatment with high success rates, which highlights the importance of exploring potential psychosocial interventions for the treatment of CUD. Given the evidence of psilocybin's therapeutic potential in the treatment of substance use disorders (de Veen et al., 2017), we aim to conduct a study using psilocybin-assisted-psychotherapy in the treatment of CUD. The study aims to evaluate the feasibility, safety, tolerability and potential therapeutic effect of 2 doses \[25 mg\] of psilocybin administered as part of an 8-week Motivational Enhancement Therapy (MET) and supportive therapy. This trial will be the first to evaluate the potential treatment effects of psilocybin on symptoms of CUD.

First Posted: 2024-01-25

Condition(s): Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): Psilocybin combined with Psychotherapy

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 16

Allocation: NA

Sponsor: McMaster University

Principal Investigator:

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT06225232

Efficacy of Contingency Management in the Treatment of Adolescents With Cannabis Use Disorders

Cannabis use among Spanish adolescents has been increasing in the last decade. It has been related to poor school achievement, delinquency, substance use and psychiatric disorders. Furthermore, psychoactive substance use in adolescents presenting psychiatric disorders can result in the development of substance use disorders or the worsening of psychopathology. Thus, there's an urge to develop efficient interventions in the treatment of these disorders. Therapeutic approaches based on cognitive-behavioural therapy and motivational interviewing have demonstrated a limited efficacy in this population. Programs based on contingency management have been reported to be useful both in adult and adolescents, too. But it still remains unclear whether a combination of these therapeutic approaches is feasible and brings a better cost-benefit relation. The investigators' project aims to evaluate the added benefits of supplementing a standard intervention on cannabis use, based on combined approach that includes motivational and cognitive-behavioural elements, with a contingency management program. Therefore, pre and post-treatment evaluation will be carried forward in a sample of 30 adolescents (aged 12-18) that initiate treatment for cannabis use related disorder at the Child and Adolescent Psychiatry Department of the Hospital Clinic in Barcelona. Participants will be randomly assigned to a standard treatment group or an experimental group in which standard treatment will be supplemented with a contingency management protocol. As a secondary objective, a prospective assessment of neuropsychological performance related to cannabis use or abstinence will be carried forward.

First Posted: 2009-04-09

Condition(s): Marijuana Abuse

Intervention(s): Standard treatment, Standard Treatment Plus Contingency Management Program

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Hospital Clinic of Barcelona

Principal Investigator:

Completion Date (primary or actual): 2010-12

CT.gov Identifier: NCT00878852

Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms

Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder characterized by clinical motor and non-motor symptoms. Knowing the potential benefits has led to the use of cannabis as an alternative therapy.

First Posted: 2024-10-08

Condition(s): Parkinson Disease

Intervention(s): Cannabidiol 100 mg/ml, cannabidiol 300 mg/ml, Cannabidiol 400 mg/ml, Placebo

Status: RECRUITING

Enrollment (expected or actual): 88

Allocation: RANDOMIZED

Sponsor: Laboratorio Elea Phoenix S.A.

Principal Investigator:

Completion Date (primary or actual): 2026-11

CT.gov Identifier: NCT06629389

Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

This is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (MediCabilis CBD Oil), in patients with Amyotrophic Lateral Sclerosis or Motor Neurone Disease. Participants will be randomised in a 1:1 ratio to receive MediCabilis CBD Oil or placebo oil. The treatment duration is 6 months with one-month safety follow up. Participants will be checked every month either face to face or via telephone and will be assessed to collect data for study objectives such as ALSFRS-R, Forced Vital Capacity, pain and spasticity score, and quality of life. Thirty (30) participants will be randomised.

First Posted: 2018-10-01

Condition(s): Amyotrophic Lateral Sclerosis, Motor Neuron Disease

Intervention(s): MediCabilis CBD Oil, Placebo Oil

Status: UNKNOWN

Enrollment (expected or actual): 17

Allocation: RANDOMIZED

Sponsor: Gold Coast Hospital and Health Service

Principal Investigator:

Completion Date (primary or actual): 2024-01-30

CT.gov Identifier: NCT03690791

Neural Correlates of Driving and Cannabis

Driving is a set of complex tasks and requires use of multiple cognitive domains, including attention, planning, and memory. In laboratory studies, the main psychoactive component in cannabis, delta-9-tetrahydrocannabinol (THC), was shown to impair short-term memory, attention, reaction time, tracking, and coordination, resulting, for instance, in significantly more deviations from the lane and increased break latency. Surveys and epidemiological studies suggest that cannabis consumption is associated with increased risks of collision. The current study aims to evaluate individual driving behavior and performance on various neurocognitive tests and their correlated neural networks while under the influence of cannabis and while sober. The investigators will use the STISIM driving simulator, which is fully MRI compatible, to study brain activation, while participants are performing various driving maneuvers. The goals of the study are: 1. identify driving performance and patterns in brain activation associated with cannabis exposure and compare them to brain patterns of the same participants while sober; 2. compare participant's performance on cognitive tasks while under the influence of cannabis and sober; 3. look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks; 4. correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis.

First Posted: 2018-07-10

Condition(s): Cannabis Use, Driving Impaired

Intervention(s): Cannabis

Status: UNKNOWN

Enrollment (expected or actual): 12

Allocation: RANDOMIZED

Sponsor: Unity Health Toronto

Principal Investigator:

Completion Date (primary or actual): 2020-12-31

CT.gov Identifier: NCT03581058

Culinary Spices in Metabolic Syndrome.

This double blind, placebo controlled randomized controlled trial aims to evaluate the effect of three commonly used culinary spices - ginger (Zingiber officinale), cinnamon (Cinnamomum) and black seed (Nigella sativa) on the cardiometabolic parameters of individuals with risk factors of metabolic syndrome. Participants consume their assigned treatment for 12 weeks, and key cardiovascular and glucometabolic parameters are recorded at baseline, week 6, and week 12 of the study.

First Posted: 2024-05-21

Condition(s): Metabolic Syndrome

Intervention(s): Ginger, black seed, cinnamon, Placebo

Status: COMPLETED

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: United Arab Emirates University

Principal Investigator: Ayesha Salem Al Dhaheri, Professor, Associate Provost, Student Affairs

Completion Date (primary or actual): 2016-11-13

CT.gov Identifier: NCT06423248

Study of an Oral Fluid Testing Approach

The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits across \~ 3-4 weeks and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~ Day 7; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~ Day 21; TLFB interview, urine test, oral fluid test, survey, interview). Individuals age 18-30 are invited to screen here: https://redcap.link/softa-bch

First Posted: 2025-03-24

Condition(s): Cannabis Use, Cannabis Intoxication, Cannabis Use Disorder

Intervention(s): Biologic testing for THC

Status: RECRUITING

Enrollment (expected or actual): 200

Allocation:

Sponsor: Boston Children's Hospital

Principal Investigator: Lydia Shrier, Research Director

Completion Date (primary or actual): 2027-05

CT.gov Identifier: NCT06891235

Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study

The goal of this study is to learn about the body's response to cannabis based products in sleep deprived people who are currently experiencing anxiety but are otherwise healthy.

First Posted: 2026-06-18

Condition(s): Healthy Volunteer

Intervention(s): THC, CBD, THC + CBD, Placebo

Status: RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: King's College London

Principal Investigator:

Completion Date (primary or actual): 2027-12-31

CT.gov Identifier: NCT07656350

Breathwork-assisted Treatment for Cannabis Use Disorder

The purpose of this proof-of-concept study is to evaluate the safety, feasibility and acceptability of a breathwork workshop intervention in individuals with cannabis use disorder.

First Posted: 2022-02-02

Condition(s): Addiction, Substance Abuse, Cannabis Use Disorder, Cannabis Use, Cannabis Dependence, Cannabis Abuse

Intervention(s): Breathwork workshop

Status: UNKNOWN

Enrollment (expected or actual): 10

Allocation: NA

Sponsor: Elias Dakwar

Principal Investigator: Elias Dakwar, Associate Professor of Clinical Psychiatry

Completion Date (primary or actual): 2025-12-31

CT.gov Identifier: NCT05219825

Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

There has been a considerable rise in cannabis consumption in recent years, with estimates of 200 million individual users globally. Importantly, 3% of these individuals have cannabis use disorder (CUD), with this prevalence increasing to 33% amongst regular users, making it one of the most common substances use disorders (SUDs) worldwide. CUD is associated with substantial health, societal, and economic costs, and worsening of other psychiatric disorders. Despite this clinical burden, effective treatment options are limited. No pharmacological treatments have emerged as clearly efficacious, and psychotherapeutic interventions have shown tempered results. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of addictions. Evidence has indicated its efficacy in reducing drug craving and consumption across numerous SUDs, although research into cannabis has been largely unexplored. Recently, a novel circular rTMS coil, the MagVenture MMC-140, has been developed with the capacity to modulate both the bilateral prefrontal cortex (PFC) and insula, both of which are implicated in the neurocircuitry of craving and executive function. As such, it shows potential for CUD treatment. This proof-of-concept clinical trial will evaluate the feasibility and tolerability of a 4-week course of rTMS to the PFC/insula using MMC-140 as a treatment for CUD. Feasibility of both high frequency (HF; excitatory) and low frequency (LF; inhibitory) stimulation parameters will be evaluated. In addition, pre/post rTMS changes in cannabis use outcomes (e.g., consumption, craving, and withdrawal), executive function, and PFC/insula functional connectivity will be explored. By comprehensively investigating clinical, cognitive, and neuroimaging effects of rTMS, this study could pave the way for the first brain-based intervention in CUD that could be widely adopted into clinical settings using a novel, cost-effective and accessible rTMS device.

First Posted: 2023-05-16

Condition(s): Cannabis Use Disorder

Intervention(s): Repetitive Transcranial Magnetic Stimulation

Status: RECRUITING

Enrollment (expected or actual): 46

Allocation: RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): 2027-06-15

CT.gov Identifier: NCT05859347

Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum

Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during pregnancy and stay quit postpartum.

First Posted: 2026-03-24

Condition(s): Perinatal, Cannabis Use, Tobacco Use, Smoking Cessation

Intervention(s): Perinatal smoking cessation treatment and maintenance sessions

Status: RECRUITING

Enrollment (expected or actual): 25

Allocation: NA

Sponsor: University of Pittsburgh

Principal Investigator: Natacha DeGenna, Associate Professor of Psychiatry, Epidemiology, Clinical and Translational Science

Completion Date (primary or actual): 2027-10

CT.gov Identifier: NCT07489443

The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience

The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation

First Posted: 2021-02-10

Condition(s): Smoking Reduction

Intervention(s): Experimental product consumption, Control product consumption

Status: COMPLETED

Enrollment (expected or actual): 140

Allocation: RANDOMIZED

Sponsor: Universidad Católica San Antonio de Murcia

Principal Investigator: Francisco Javier López Román, Principal Investigator

Completion Date (primary or actual): 2021-12-31

CT.gov Identifier: NCT04749017

Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease

Parkinson's disease (PD) is a leading neurodegenerative movement disorder, marked by a gradual loss of dopamine-producing neurons in the substantia nigra pars compacta (SNpc) and the accumulation of α-synuclein protein aggregates. Silymarin, a polyphenolic flavonoid renowned for its potent antioxidant properties, will be studied for its neuroprotective effects in PD.

First Posted: 2025-06-03

Condition(s): Parkinson Disease

Intervention(s): levodopa-carbidopa, Silymarin

Status: RECRUITING

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Tanta University

Principal Investigator: Nour Amr Ahmed Mosaad Elsherbeny, Teaching Assistant

Completion Date (primary or actual): 2026-05-30

CT.gov Identifier: NCT07001150

Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to ensure that our planned self-titration regimen is appropriate using Sativex. This phase will be open label, with no placebo control. Then, there will be a twelve-week, double-blind, placebo-controlled study in male and female subjects seeking treatment for cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to come daily to the centre to assess usage of medication. Following the medication phase, participants will have a follow-up weekly for another four weeks and then monthly until the 6 month follow up visit after the target quit date. The investigators are planning to enroll 45 subjects over the two-year period.

First Posted: 2012-12-12

Condition(s): Cannabis Dependence

Intervention(s): Motivational Enhancement/Cognitive Behavioral Therapy, Sativex, Placebo spray

Status: COMPLETED

Enrollment (expected or actual): 45

Allocation: RANDOMIZED

Sponsor: Centre for Addiction and Mental Health

Principal Investigator: Bernard Le Foll, Head, Translational Addiction Research Laboratory

Completion Date (primary or actual): 2015-11

CT.gov Identifier: NCT01747850

Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)

This is an ancillary study, thus participants will be recruited from participants in the HBS Study. This project acutely assesses the role of the e-cigarettes and vaping on lung health. The proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.

First Posted: 2021-03-12

Condition(s): Hiv, Lung Injury

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation:

Sponsor: Pennington Biomedical Research Center

Principal Investigator: John Apolzan, Assistant Professor, Director Clinical Nutrition and Metabolism Lab

Completion Date (primary or actual): 2023-12-04

CT.gov Identifier: NCT04794543

Dronabinol Interactions With Cognitive Enhancing Drug in Humans

Marijuana use is a major problem among veterans and non-veterans. A patient's use of marijuana while engaged in psychotherapy treatment may affect their memory and, therefore, limit their ability to benefit from treatment. This study is designed to test a new pharmacotherapy, modafinil, which has the potential to improve memory functioning in marijuana using individuals. We hypothesize that modafinil treatment will decrease ratings of drug liking and improve cognitive measures, especially episodic memory.

First Posted: 2009-02-12

Condition(s): Cannabis, Marijuana Abuse

Intervention(s): drug condition

Status: COMPLETED

Enrollment (expected or actual): 53

Allocation:

Sponsor: Yale University

Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D.

Completion Date (primary or actual): 2009-10

CT.gov Identifier: NCT00842985

Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy

This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne.

First Posted: 2024-04-12

Condition(s): Acne Vulgaris (Disorder)

Intervention(s): Microneedling with CBD

Status: UNKNOWN

Enrollment (expected or actual): 20

Allocation: NA

Sponsor: Rejuva Medical Aesthetics

Principal Investigator:

Completion Date (primary or actual): 2025-12

CT.gov Identifier: NCT06362889

An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents

The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.

First Posted: 2007-10-11

Condition(s): Cannabis Dependence

Intervention(s): N-Acetylcysteine

Status: COMPLETED

Enrollment (expected or actual): 24

Allocation: NA

Sponsor: Medical University of South Carolina

Principal Investigator: Kevin Gray, MD, Professor of Psychiatry and Behavioral Sciences

Completion Date (primary or actual): 2008-12

CT.gov Identifier: NCT00542750

Treosulfan and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Nonmalignant Inherited Disorders

This phase II clinical trial studies how well treosulfan and fludarabine phosphate with or without low dose radiation before donor stem cell transplantation works in treating patients with nonmalignant (noncancerous) diseases. Hematopoietic cell transplantation has been shown to be curative for many patients with nonmalignant (noncancerous) diseases such as primary immunodeficiency disorders, bone marrow failure syndromes, hemoglobinopathies, and inborn errors of metabolism (metabolic disorders). Powerful chemotherapy drugs and/or radiation are often used to condition the patient before infusion of the new healthy donor cells. The purpose of the conditioning therapy is to destroy the patient's abnormal bone marrow which doesn't work properly in order to make way for the new healthy donor cells which functions normally. Although effective in curing the patient's disease, many hematopoietic cell transplantation regimens use intensive chemotherapy and/or radiation which can be quite toxic, have significant side effects, and can potentially be life-threatening. Investigators are investigating whether a new conditioning regimen that uses less intensive drugs (treosulfan and fludarabine phosphate) with or without low dose radiation results in new blood-forming cells (engraftment) of the new donor cells without increased toxicities in patients with nonmalignant (noncancerous) diseases.

First Posted: 2009-06-12

Condition(s): Non-Neoplastic Hematologic and Lymphocytic Disorder

Intervention(s): Allogeneic Bone Marrow Transplantation, Anti-Thymocyte Globulin, Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Methotrexate, Mycophenolate Mofetil, Peripheral Blood Stem Cell Transplantation, Tacrolimus, Total-Body Irradiation, Treosulfan, Umbilical Cord Blood Transplantation

Status: COMPLETED

Enrollment (expected or actual): 98

Allocation: NON_RANDOMIZED

Sponsor: Fred Hutchinson Cancer Center

Principal Investigator: Lauri Burroughs, Associate Professor, Clinical Research Division, Fred Hutch; Director, Non-Malignant Transplant Program

Completion Date (primary or actual): 2020-06-10

CT.gov Identifier: NCT00919503

Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.

First Posted: 2019-01-31

Condition(s): Atopic Dermatitis

Intervention(s): BTX 1204, Vehicle

Status: COMPLETED

Enrollment (expected or actual): 200

Allocation: RANDOMIZED

Sponsor: Botanix Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2020-03-04

CT.gov Identifier: NCT03824405

Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.

First Posted: 2005-09-02

Condition(s): Attention Deficit Disorder With Hyperactivity, Marijuana Abuse

Intervention(s): Atomoxetine, placebo

Status: COMPLETED

Enrollment (expected or actual): 2

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Frances R Levin, Director of Substance Use Disorder

Completion Date (primary or actual): 2007-01

CT.gov Identifier: NCT00142961

Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.

Gender-based or sexual violence, or violence against women (VAW), is a global public health problem affecting around 30% of women over the age of 15, with significant consequences for physical and mental health, including depression and post-traumatic stress disorder (PTSD). In 2019, the French National Authority for Health (HAS) published recommendations in two parts, one for identifying women who are victims of domestic violence, and the other for dealing with a woman who has been exposed to such violence. But violence against women is not limited to the marital sphere. VAW can simply be detected in a consultation using a translated version of the Abuse Assessment Screen (AAS) questionnaire. Women who are victims of VAW have specific needs linked to the often repeated nature of the violence they experience, and the complex trauma that can ensue. They also tend to combine other risk factors for poor mental health, such as economic insecurity and social isolation. In France, dealing with the specific medical, psychosocial and legal needs of victims-survivors of VAW has come up against a number of obstacles, including a lack of dedicated care facilities, a lack of trained professionals and a lack of coordination between the various parties. Health professionals rarely receive the training they need to deal with VAW-related issues with confidence and professionalism, and often lack the resources to refer female victims to appropriate care. "La Maison des Femmes" (MdF) was set up in 2016 in Saint-Denis, located in a department where a quarter of the women who consult a family planning centre (FPC) has suffered from VAW. It is a hospital service specifically dedicated to the individualised, multidisciplinary care of victims-survivors of VAW, offering health, social and legal support within the same facility. The MdF comprises 4 units: a FPC, a violence management unit (involving doctors, midwives, psychologists, social workers, lawyers, police officers and support groups), a female genital mutilation management unit (surgeons and sexologists) and a 24/7 reception unit for victims of sexual violence. Several MdF-inspired care structures have been set up in France. The service provided by these facilities needs to be evaluated, particularly in terms of their ability to improve the physical and mental health, including post-traumatic stress, of women who have been victims of VAW.

First Posted: 2024-01-26

Condition(s): Domestic and/or Sexual Violence

Intervention(s): completion of scales and questionnaires

Status: RECRUITING

Enrollment (expected or actual): 360

Allocation:

Sponsor: Centre Hospitalier Universitaire Dijon

Principal Investigator:

Completion Date (primary or actual): 2028-02

CT.gov Identifier: NCT06226818

Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

First Posted: 2006-09-27

Condition(s): Diabetic Neuropathies

Intervention(s): Cesamet™ (nabilone)

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: NON_RANDOMIZED

Sponsor: NEMA Research, Inc.

Principal Investigator:

Completion Date (primary or actual): 2007-10

CT.gov Identifier: NCT00380913

Warrior CARE: Cannabis Behavioral Health

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

First Posted: 2024-04-24

Condition(s): Post Traumatic Stress Disorder, Cannabis Use, Suicide, Veterans, Marijuana

Intervention(s): Tetrahydrocannabinol, Cannabidiol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 500

Allocation: RANDOMIZED

Sponsor: Wayne State University

Principal Investigator: Leslie Lundahl, Professor

Completion Date (primary or actual): 2030-12-31

CT.gov Identifier: NCT06381180

PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial

Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving success during therapeutic ERCP is selective biliary cannulation (SBC). Nevertheless, SBC doesn't consistently yield favorable outcomes, even among expert endoscopists, failing in around 25% to 50% of cases with standard ERCP approach (sphincterotome and guidewire). In such situations, depending on the endoscopist's experience and preference, various advanced techniques come into play. These encompass the double guidewire cannulation approach, needle-knife precut papillotomy or fistulotomy, and transpancreatic sphincterotomy, serving as potential rescue methods. In recent times, the EUS-guided approach has been gaining increasing significance. Initially, it was viewed as a rescue option in cases where advanced ERCP techniques failed (5-15% of cases). More recently, it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction.

First Posted: 2024-08-13

Condition(s): Malignant Biliary Obstruction

Intervention(s): pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique

Status: UNKNOWN

Enrollment (expected or actual): 220

Allocation: RANDOMIZED

Sponsor: Istituto Clinico Humanitas

Principal Investigator:

Completion Date (primary or actual): 2026-09-30

CT.gov Identifier: NCT06550973

The CanISleepinMS Study: Effect of Cannabidiol (CBD) on Sleep Quality in Patients With Multiple Sclerosis

Evaluating the effect of 300 mg purified cannabidiol (CBD) on sleep quality in patients with multiple sclerosis (MS).

First Posted: 2026-09-25

Condition(s): Sleep Quality, Multiple Sclerosis, Insomnia

Intervention(s): Cannabidiol Oil

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: RANDOMIZED

Sponsor: Wageningen University

Principal Investigator: Renger Witkamp, Prof.dr. Renger F. Witkamp (Emeritus Professor Nutritional Biology)

Completion Date (primary or actual): 2026-03-28

CT.gov Identifier: NCT07840924

CBD Supplementation in Brazilian Jiu-Jitsu Athletes

Brazilian Jiu-Jitsu (BJJ) is a high-intensity martial art that imposes significant physical and physiological demands on practitioners, including rigorous training and frequent competitions, which can result in chronic inflammation, delayed-onset muscle soreness (DOMS), sleep disturbances, and reduced quality of life. Effective recovery strategies are essential to optimize athletic performance and longevity in the sport. Cannabidiol (CBD), a non-psychotomimetic phytocannabinoid derived from Cannabis sativa, has emerged as a promising therapeutic agent due to its anti-inflammatory, analgesic, anxiolytic, and neuroprotective properties. Preclinical studies indicate that CBD modulates inflammatory pathways, such as inhibition of NF-κB and NLRP3, thereby reducing pro-inflammatory cytokines such as IL-6, TNF-α, IL-8, and IL-1β, while increasing the anti-inflammatory cytokine IL-10. In clinical contexts, CBD has shown potential to attenuate DOMS and improve sleep without the adverse effects associated with non-steroidal anti-inflammatory drugs (NSAIDs). However, evidence in BJJ athletes remains limited, with gaps in the translation of preclinical findings to healthy athletic populations. The prevalence of injuries in combat sports can reach 28%, with contusions and sprains being common and further exacerbating inflammation and pain. Although approximately 23.4% of athletes report cannabis use, there is a lack of randomized controlled trials (RCTs) specifically for BJJ evaluating isolated CBD at standardized doses. Furthermore, concerns regarding hepatotoxicity, monitored through enzymes such as AST and ALT, require rigorous safety evaluation. This protocol describes an RCT to investigate the effects of 200 mg/day of isolated CBD for 12 weeks in BJJ athletes, focusing on sensitive inflammatory markers (IL-6 as the primary pro-inflammatory marker and IL-10 as the anti-inflammatory marker), pain, sleep, and quality of life. The study aims to address gaps identified in systematic reviews and provide an evidence-based foundation for future recommendations.

First Posted: 2026-04-27

Condition(s): Pro and Anti Inflamatory Cytokines, Pain, Sleep, Quality of Life

Intervention(s): CBD Isolate 100mg BID, Placebo

Status: NOT_YET_RECRUITING

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Associação Pan-Americana Multidisciplinar de Endocanabinologia

Principal Investigator:

Completion Date (primary or actual): 2027-07-31

CT.gov Identifier: NCT07552974

Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs

Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances)

First Posted: 2017-05-03

Condition(s): Low Back Pain

Intervention(s): standard medications crossed over to cannabis

Status: COMPLETED

Enrollment (expected or actual): 100

Allocation:

Sponsor: Rabin Medical Center

Principal Investigator: DROR ROBINSON, Head Orthopedic Research Unit

Completion Date (primary or actual): 2018-08-01

CT.gov Identifier: NCT03138460

Dopaminergic Dysfunction in Late-Life Depression

Late-Life Depression (LLD), or depression in older adults, often presents with motivational deficits, deficits in performance in cognitive domains including processing speed and executive dysfunction, and mobility impairments. This triad of findings implicate dopaminergic dysfunction as a core pathophysiologic feature in depression, and may contribute to cognitive decline and motor disability. Normal aging results in brain-wide dopamine declines, decreased D1/D2 receptor density, and loss of dopamine transporters. Although brain changes associated with depression and aging converge on dopamine circuits, the specific disturbances in LLD and how responsive the system is to modulation remain unclear. In this study, investigators are testing integrative model that aging, in concert with pro-inflammatory shifts, decreases dopamine signaling. These signally changes affects behaviors supported by these circuits, in the context of age-associated cortical atrophy and ischemic microvascular changes, resulting in variable LLD phenotypes. Investigators propose a primary pathway where dopaminergic dysfunction in depressed elders contributes to slowed processing speed and mobility impairments that increase the effort cost associated with voluntary behavior. The central hypothesis of this study is that late-life depression is characterized by dysfunction in the dopamine system and, by enhancing dopamine functioning in the brain. By improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms.

First Posted: 2020-07-14

Condition(s): Late Life Depression, Cognitive Decline, Depressive Disorder, Treatment-Resistant, Levodopa, Gait Impairment

Intervention(s): L-Dopa, Placebo

Status: COMPLETED

Enrollment (expected or actual): 79

Allocation: RANDOMIZED

Sponsor: Vanderbilt University Medical Center

Principal Investigator: Patricia Andrews, Professor of Psychiatry

Completion Date (primary or actual): 2026-04-29

CT.gov Identifier: NCT04469959

CHI-907 CBD Extract and Experiences of Test Anxiety

This is a randomized, placebo-controlled study examining the effects of CHI-907 on test anxiety specifically, and state anxiety more broadly.

First Posted: 2020-02-13

Condition(s): Anxiety

Intervention(s): CHI-907, CHI-804

Status: TERMINATED

Enrollment (expected or actual): 32

Allocation: RANDOMIZED

Sponsor: Canopy Growth Corporation

Principal Investigator:

Completion Date (primary or actual): 2021-06-01

CT.gov Identifier: NCT04269252

Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients

The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.

First Posted: 2012-04-02

Condition(s): Parkinson's Disease

Intervention(s): Placebo, BIA 9-1067, BIA 9-1067, BIA 9-1067, Levodopa/Carbidopa, Levodopa/Benzerazide

Status: COMPLETED

Enrollment (expected or actual): 40

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2010-06

CT.gov Identifier: NCT01568047

A Brief Marijuana Intervention for Adolescent Women - 1

The purpose of this study is to examine the efficacy of a brief motivational intervention on marijuana use and sex-risk behavior in young women.

First Posted: 2005-09-28

Condition(s): Marijuana Abuse, Sexual Risk Behaviors

Intervention(s): Behavior Therapy, Treatment as Usual

Status: COMPLETED

Enrollment (expected or actual): 326

Allocation: RANDOMIZED

Sponsor: Butler Hospital

Principal Investigator: Michael Stein, MD, PI

Completion Date (primary or actual): 2009-12

CT.gov Identifier: NCT00227864

The Role of JAK2 in Alveolar Macrophages (AM's) in Chronic Beryllium Disease (CBD)

Current studies suggest that alveolar macrophages (AM) act as silencers of most immune responses in the lung. However, in pathological conditions, such as asthma, hypersensitivity pneumonitis, and sarcoidosis, AMs become involved in the maintenance and further expansion of the immune response in the target organ. The Investigator has preliminary data demonstrating that CBD AMs at the site of disease involvement (bronchoalveolar lavage, BAL) display an activated cell surface phenotype compared to AMs from healthy controls. Furthermore, exciting data from our group demonstrates significant differences in gene expression profiles between CBD and Beryllium Sensitivity (BeS) bronchial alveolar lavage (BAL) cells, in pivotal immune response genes and networks. Specifically, the Investigator has found the JAK/STAT pathway and the JAK2 gene was dramatically overexpressed in CBD BAL cells. In addition, constitutively phosphorylated JAK2 (pJAK2) was found in AMs from Chronic Beryllium Disease (CBD) patients by Westernblot and was increased after beryllium (Be) stimulation for 30 min. Moreover, the JAK2 inhibitor TG101348 significantly inhibited Be-induced CBD AMs TNFa and IFNy production. Meanwhile, overexpression of the JAK2 inhibitor SOCS 1 (suppressors of cytokine signaling) protein decreased Be-induced TNFa production from AMs. Based on this information, the Investigator hypothesizes that CBD AMs overexpress JAK2, which augments the immune response to Be and development of CBD but not BeS. The investigators believe that these studies are highly innovative since they will undoubtedly shed light on exposure-mediated immune dysregulation in Alveolar Macrophages (AMs) that lead to disease development and likely progression and with additional study of this pathway will reveal potential biomarkers for clinical prognosis and diagnosis. The results obtained from this study will improve the investigators understanding of factors involved in the development of Chronic Beryllium disease (CBD), as well as define targets for therapy, and will serve as a model of other exposure-related immune responses and environmentally-induced chronic diseases. Most importantly, these studies will provide the investigator with preliminary data to submit a high quality R01, allowing the Investigator to apply similar approaches to other genes, define a potential target for this and other similar immune-mediated diseases and continue research efforts at National Jewish Health (NJH.)

First Posted: 2015-11-04

Condition(s): Chronic Beryllium Disease (CBD), Beryllium Sensitization (BeS)

Intervention(s): Blood draw, bronchoscopy

Status: COMPLETED

Enrollment (expected or actual): 3

Allocation:

Sponsor: National Jewish Health

Principal Investigator: Li Li, Dr.

Completion Date (primary or actual): 2019-12-06

CT.gov Identifier: NCT02596347

RCT of CBD for Anxiety in Advanced Breast Cancer

This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: \- Cannabidiol (CBD)

First Posted: 2020-07-22

Condition(s): Advanced Breast Cancer, Anxiety, CBD

Intervention(s): Cannabidiol, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Dana-Farber Cancer Institute

Principal Investigator: Ilana Braun, MD, Principal Investigator

Completion Date (primary or actual): 2027-12-01

CT.gov Identifier: NCT04482244

Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics

This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.

First Posted: 2024-05-17

Condition(s): Breast Carcinoma, Colorectal Carcinoma, Lung Non-Small Cell Carcinoma, Melanoma, Non-Hodgkin Lymphoma

Intervention(s): Non-interventional Study

Status: RECRUITING

Enrollment (expected or actual): 2000

Allocation:

Sponsor: Wake Forest University Health Sciences

Principal Investigator:

Completion Date (primary or actual): 2028-08-01

CT.gov Identifier: NCT06418204

An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.

First Posted: 2015-11-18

Condition(s): Epilepsy

Intervention(s): GWP42003-P

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: NA

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2019-05-27

CT.gov Identifier: NCT02607904

Study to Assess Food Effect on Sativex Bioavailability

Study to assess effect of food on the bioavailability of a single dose of Sativex and to measure its' pharmacokinetics after a single and multiple doses.

First Posted: 2011-03-24

Condition(s): Food Effect

Intervention(s): Sativex, Sativex, Sativex, Sativex

Status: COMPLETED

Enrollment (expected or actual): 25

Allocation: RANDOMIZED

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2008-02

CT.gov Identifier: NCT01322464

Pregnenolone and Marijuana Dependence

The cannabinoid delta 9-tetrahydrocannabinol (THC) is the primary psychoactive component of marijuana. THC is believed to be a significant factor in the addictive potential associated with marijuana use. In addition, attenuated levels of endogenous endocannabinoids have been found in alcohol-dependent individuals as compared to social drinkers, suggesting that changes in the sensitivity of the endogenous endocannabinoid system play a role in the transition from recreational drug use to substance use disorders. Thus, pharmacotherapies that target the cannabinoid system may be effective strategies for reducing marijuana use and dependence. Recent preclinical data demonstrate that the neurosteroid pregnenolone (PREG) inhibits THC activation of cannabinoid receptors and decreases symptoms of marijuana intoxication. In addition, other studies show that PREG inhibits drug-seeking behavior. This pilot study will provide important preliminary data on the effect of an acute dose of PREG on cue-related craving in individuals with cannabis use disorder.

First Posted: 2015-05-12

Condition(s): Marijuana Dependence

Intervention(s): Pregnenolone, Placebo

Status: COMPLETED

Enrollment (expected or actual): 21

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator:

Completion Date (primary or actual): 2016-04

CT.gov Identifier: NCT02439814

Characterization of the Pharmacodynamic Response to Vaped THC

This study aims to characterize the pharmacodynamic response to vaped THC in young adult, occasional cannabis users with respect to outcomes such as stimulation and sedative effects, mood, anxiety, and craving, as well as cognitive and objective outcomes such as heart rate and cortisol changes with THC vs placebo.

First Posted: 2020-04-09

Condition(s): Vaping, THC

Intervention(s): THC or Placebo

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Massachusetts General Hospital

Principal Investigator: A. Eden Evins, Director, Center for Addiction Medicine; Professor in Psychiatry

Completion Date (primary or actual): 2025-10-01

CT.gov Identifier: NCT04340700

Boxing Training for Upper Limb Functions, Balance, and Quality of Life in Stroke

The World Health Organization's (WHO) definition of stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than a vascular origin'.Stroke has further three types i.e. ischemic, hemorrhagic, and transient ischemic stroke. As most gestures in daily life involve the upper limbs and hands, patients who cannot use their hands not only suffer from severe physical and psychological pain but also encounter difﬁculties in the activities of daily living that primarily involve upper limb function. Stroke patients have various problems such as asymmetrical posture, abnormal body balance, and decreased ability to move the weight.

First Posted: 2021-08-30

Condition(s): Stroke

Intervention(s): Boxing training, Task Oriented Training

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Riphah International University

Principal Investigator:

Completion Date (primary or actual): 2022-08-20

CT.gov Identifier: NCT05026099

Bioequivalence Bewteen DopaSnap® (Cabidopa/Levopdoap 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet (Actavis)

This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:

First Posted: 2020-01-22

Condition(s): Other

Intervention(s): DopaSnap®, RDL of CD-LD

Status: COMPLETED

Enrollment (expected or actual): 57

Allocation: RANDOMIZED

Sponsor: Riverside Pharmacueticals Corporation

Principal Investigator:

Completion Date (primary or actual): 2019-12-01

CT.gov Identifier: NCT04236921

Dopaminergic Modulation of Cognition and Psychomotor Function

A recent study at our lab showed increased episodic memory consolidation and response readiness after treatment with methylphenidate in healthy volunteers. The investigators seek to replicate and extend these findings. Furthermore the pharmacological specificity of these effects will be studied. Since methylphenidate has an effect on two neurotransmitters, dopamine and noradrenaline, either could be responsible for the observed effects. In order to explore the dopaminergic contribution to this effect, the study proposed here includes not only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not noradrenaline. In this study, 20 healthy males and females between 18 and 45 years of age will participate. They will be recruited via advertisements at Maastricht University and in local newspapers. Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once with placebo. All medications will be administered orally with a capsule. It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic memory consolidation and improve response readiness

First Posted: 2010-10-11

Condition(s): Dopamine Activity, Episodic Memory Consolidation, Response Preparation

Intervention(s): Methylphenidate 40 mg, Levodopa/carbidopa 125 mg, Domperidon 10 mg

Status: COMPLETED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Maastricht University Medical Center

Principal Investigator:

Completion Date (primary or actual): 2012-06

CT.gov Identifier: NCT01218425

Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study

Self-medication of pain by consuming alcohol and marijuana is common. However, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. The study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users. This will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.

First Posted: 2021-03-10

Condition(s): Chronic Pain

Intervention(s): Eccentric Biceps Flexion, Concentric Biceps Flexion

Status: COMPLETED

Enrollment (expected or actual): 51

Allocation: RANDOMIZED

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): 2022-05-10

CT.gov Identifier: NCT04791917

Pain, Inflammation, and Cannabis in HIV

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study how varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation and adverse events.

First Posted: 2021-04-26

Condition(s): HIV Infections, Neuropathic Pain, Cannabis

Intervention(s):

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation:

Sponsor: Montefiore Medical Center

Principal Investigator: Deepika Slawek, Assistant Professor of Medicine

Completion Date (primary or actual): 2025-06-30

CT.gov Identifier: NCT04860089

COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE

General objective: To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users. Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed. Patients will be randomly assigned to one of two treatments: 1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment 2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment

First Posted: 2014-12-18

Condition(s): First-episode Psychosis, Cannabis Abuse

Intervention(s): Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse, Psychoeducation

Status: COMPLETED

Enrollment (expected or actual): 88

Allocation: RANDOMIZED

Sponsor: Basque Health Service

Principal Investigator: Itxaso Ortega Gonzalez, Itxsaso Gonzalez Ortega

Completion Date (primary or actual): 2019-09

CT.gov Identifier: NCT02319746

A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects

To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol (CBD)) by comparing the PK profile of Sativex in healthy subjects. The primary clinical hypothesis is that there will be an effect of oral pH on the PK of Sativex when administered as a single oromucosal dose (four sprays).

First Posted: 2014-09-15

Condition(s): Healthy Volunteers

Intervention(s): Sativex

Status: TERMINATED

Enrollment (expected or actual): 6

Allocation: RANDOMIZED

Sponsor: GW Pharmaceuticals Ltd

Principal Investigator:

Completion Date (primary or actual): 2015-10

CT.gov Identifier: NCT02240160

A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence

Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol craving. Quality of life and neurobiological and biochemical markers for craving will serve as secondary outcomes, because they show strong associations to treatment outcome and relapse risk. Collection and analysis of follow-up data (28 days, 42 days, 105 days, 196 days) will be performed to determine whether treatment effects relate to patient outcome.

First Posted: 2025-02-25

Condition(s): Alcohol Addiction, Alcoholism

Intervention(s): Cannabidiol capsules, Naltrexone (drug), Placebo

Status: RECRUITING

Enrollment (expected or actual): 150

Allocation: RANDOMIZED

Sponsor: Central Institute of Mental Health, Mannheim

Principal Investigator:

Completion Date (primary or actual): 2028-09-30

CT.gov Identifier: NCT06845124

Management for Concomitant Gallstones and Common Bile Duct Stones.

Choledocholithiasis is identified in approximately 3-10 % of patients with cholelithiasis. (1-3) While laparoscopic cholecystectomy (LC) is considered the treatment of choice in patients with gall bladder stones, there is a debate about the management of common bile duct (CBD) stones, (4) and this has led to a range of therapeutic strategies for the management of concomitant gallstones and CBD stones patients. Two-stage endoscopic management using endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy is a common approach, although single-stage management by laparoscopic cholecystectomy with surgical exploration of the CBD is an alternative, with the single-stage approach more common in the open surgery era. Currently, it is unclear whether two-stage management is better than or at least equivalent to the single-stage surgical approach to choledocholithiasis. To address this, we undertook this study to compare these two approaches. The aim of this prospective randomized trial was to determine the best technique for the management of patients with concomitant gallstones and common bile duct stones, by comparing the success rate, complication rates, and longer-term follow-up outcomes.

First Posted: 2021-02-17

Condition(s): Calculus Biliary

Intervention(s): Cholecystectomy

Status: UNKNOWN

Enrollment (expected or actual): 64

Allocation: NON_RANDOMIZED

Sponsor: Assiut University

Principal Investigator: Hossam Mahmoud Ibrahim, Resident

Completion Date (primary or actual): 2026-09-01

CT.gov Identifier: NCT04758923

Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders

This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with cannabis use disorder (CUD) and anxiety disorders.

First Posted: 2013-06-12

Condition(s): Cannabis Dependence, Anxiety Disorders, Cannabis Use Disorder, Cannabis Abuse

Intervention(s): Cognitive-Behavioral Therapy, Motivation Enhancement Therapy, Integrated Cannabis and Anxiety Reduction Treatment, False Safety Behavior Elimination Therapy

Status: COMPLETED

Enrollment (expected or actual): 68

Allocation: RANDOMIZED

Sponsor: Louisiana State University and A&M College

Principal Investigator: Julia Buckner, Associate Professor

Completion Date (primary or actual): 2016-07

CT.gov Identifier: NCT01875796

Eye Tracking as a Biomarker of Cannabis Effects

Biomarkers of recent drug use and intoxication have societal relevance, in that they are used by law enforcement and other agencies to detect drug impairment. For instance, a breathalyzer can quickly and accurately detect blood alcohol content (BAC) to indicate if a person is under the influence of alcohol; however, there is currently no similar way to quickly detect if a person is under the influence of cannabis. In light of increasing cannabis use, it is important to define a quantitative, objective method of determining recent use and intoxication. The link between changes in eye characteristics (e.g. movement, pupil dilation) and cannabis use is documented (Peragallo et al. 2013), but insufficiently characterized. Certain outcomes of eye behavior are known to be affected by recent cannabis use (e.g. the eyes' ability to converge on a target; Stapleton et al 1986), while findings are mixed regarding other outcomes (e.g. the eyes' ability to smoothly follow a target; Fant et al. 1998). Thus, the goal of this study is to identify a characteristic pattern of eye behavior, defined by performance on a battery of four eye tasks, as a function of recent cannabis use (7% vs. 0% THC). Using 30 healthy cannabis users (15 men, 15 women), this study will be one of the first to assess changes in eye behavior as a function of recent cannabis use within a quantified virtual reality (VR) environment. This study will examine the effect of smoked cannabis (7% vs. 0% THC) on individual eye movements, with the goal of defining the utility of the eyes as potential objective indicators of cannabis use and intoxication. Four eye tests (nystagmus, smooth pursuit, convergence, and pupillary light response; outlined below), which previous literature has defined as effective in detecting recent drug use (including opioids and alcohol; Murillo et al. 2004), have been compiled into a 5-minute task battery using a VR headset environment equipped with high frequency infrared eye trackers (the HTC Vive with Pupil Labs Tracking). This 5-minute VR battery of four eye tests will be administered prior to cannabis consumption as a baseline, and then at 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 min after cannabis, with the goal of comparing baseline values to the ten post-cannabis timepoints to detect changes in eye behavior as a function of cannabis intoxication. The study will also utilize a battery of subjective-effects and mood visual analogue scales (0-100 mm; e.g. 'Good Drug Effect') prior to the eye test battery at each timepoint, allowing us to correlate each outcome of the eye tasks to subjectively reported cannabis impairment and mood. In addition to measuring eye behavior as a function of cannabis use, the training session of this study will be used to also collect exploratory data on the relationship between pupil dilation and experimental pain. Using Quantitative Sensory Testing (Medoc TSA-II NeuroSensory Analyzer), thermal pain threshold and tolerance will be induced using a cold stimulus (4.0°C; induced with a 30 x 30 mm Peltier thermode, which is 1.5" square metal applicator that is connected to the TSA-II NeuroSensory Analyzer device and software, and produces an ongoing cold sensation applied to the lower palm of the participant's non-dominant hand). Participants will indicate first feelings of pain (pain threshold), and when the pain becomes too much to bear (pain tolerance) by pressing a button on a controller connected to the TSA-II. Throughout exposure to the cold stimulus, changes in pupil size to the patient's subjectively reported pain latencies will be recorded.

First Posted: 2019-09-24

Condition(s): Cannabis Use, Pain, Acute

Intervention(s): Cannabis

Status: TERMINATED

Enrollment (expected or actual): 1

Allocation: RANDOMIZED

Sponsor: New York State Psychiatric Institute

Principal Investigator: Caroline A. Arout, Ph.D., Assistant Professor of Neurobiology

Completion Date (primary or actual): 2020-01-31

CT.gov Identifier: NCT04100590

Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the treatment of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

First Posted: 2019-09-06

Condition(s): Posttraumatic Stress Disorder

Intervention(s): Placebo capsule, Dronabinol 7.5 milligram oral capsule

Status: COMPLETED

Enrollment (expected or actual): 102

Allocation: RANDOMIZED

Sponsor: Wayne State University

Principal Investigator: Christine Rabinak, PhD, Associate Professor & Principal Investigator

Completion Date (primary or actual): 2025-05-31

CT.gov Identifier: NCT04080427

Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 120 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.

First Posted: 2022-12-09

Condition(s): Agitation, Dementia

Intervention(s): T2:C100, Placebo

Status: COMPLETED

Enrollment (expected or actual): 120

Allocation: RANDOMIZED

Sponsor: University of Southern California

Principal Investigator: Paul S. Aisen, Professor

Completion Date (primary or actual): 2026-04-28

CT.gov Identifier: NCT05644262

A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.

This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of care (SoC), in reducing agitation and disruptive behaviors in subjects with dementia including probable AD.

First Posted: 2024-01-22

Condition(s): Agitation,Psychomotor, Disruptive Behavior, Dementia, Alzheimer Disease

Intervention(s): Medical Cannabis, Placebo Oil

Status: TERMINATED

Enrollment (expected or actual): 24

Allocation: NON_RANDOMIZED

Sponsor: M. H MediCane Ltd.

Principal Investigator:

Completion Date (primary or actual): 2024-03-10

CT.gov Identifier: NCT06217146

Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia

Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia, there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders. The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo.

First Posted: 2023-05-03

Condition(s): Insomnia

Intervention(s): Cannabidiol (CBD) Capsule 75mg, Placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 519

Allocation: RANDOMIZED

Sponsor: Avecho Biotechnology

Principal Investigator:

Completion Date (primary or actual): 2027-12

CT.gov Identifier: NCT05840822

Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®

To determine if PT intervention will be improved while in the "on" motor state vs. the "end-of-dose-off" motor state during the PT Intervention Visit in subjects with PD.

First Posted: 2015-09-15

Condition(s): Parkinson's Disease, Motor Symptoms

Intervention(s): APOKYN, Physical Therapy

Status: TERMINATED

Enrollment (expected or actual): 13

Allocation: RANDOMIZED

Sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2016-12

CT.gov Identifier: NCT02549573

Study of Cannabidiol (CBD) in Healthy Volunteers

This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults

First Posted: 2024-02-29

Condition(s): Immune System and Related Disorders, Immune System Diseases

Intervention(s): Cannabidiol (CBD)

Status: COMPLETED

Enrollment (expected or actual): 26

Allocation: RANDOMIZED

Sponsor: NextEvo Inc.

Principal Investigator:

Completion Date (primary or actual): 2022-12-14

CT.gov Identifier: NCT06286839

Enhancement of Stroke Rehabilitation With Levodopa

Trial investigates the benefits and harms of Levodopa /Carbidopa 100/25mg compared to placebo (given in addition to standardized rehabilitation based on the principles of motor learning) and whether there is an association with a patient-relevant enhancement of functional recovery in acute stroke patients. Study participants will be randomized 1:1.

First Posted: 2018-11-08

Condition(s): Acute Stroke, Stroke Rehabilitation

Intervention(s): IMP Levodopa 100mg/Carbidopa 25mg, Matching placebo

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 610

Allocation: RANDOMIZED

Sponsor: University Hospital, Basel, Switzerland

Principal Investigator:

Completion Date (primary or actual): 2029-06-30

CT.gov Identifier: NCT03735901

A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients

Flexilev is a Parkinson's disease medicine made of small, dissolvable tablets containing low doses of levodopa and carbidopa, allowing doses to be adjusted in small, precise steps. OraFID is a new mechanical device that dispenses the exact number of tablets needed, with better than 99% accuracy, in amounts from 1 to 20 tablets. An optional companion app, Levilog, reminds patients when to take their dose and records how much medicine (tablets and milligrams) was taken. This 12-week study will mainly assess how acceptable this treatment routine is and how well patients stick with it when using Flexilev with the OraFID device and app. It will also evaluate the treatment's efficacy, safety, and tolerability.

First Posted: 2026-09-24

Condition(s): PARKINSON DISEASE (Disorder)

Intervention(s): OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device

Status: RECRUITING

Enrollment (expected or actual): 58

Allocation: NA

Sponsor: Navamedic AB

Principal Investigator:

Completion Date (primary or actual): 2027-06-30

CT.gov Identifier: NCT07839793

Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

First Posted: 2022-08-29

Condition(s): Sickle Cell Disease

Intervention(s): Dronabinol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 60

Allocation: RANDOMIZED

Sponsor: Icahn School of Medicine at Mount Sinai

Principal Investigator: Susanna Curtis, Assistant Professor

Completion Date (primary or actual): 2027-05-01

CT.gov Identifier: NCT05519111

Oral Cannabidiol for Tobacco Cessation

Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.

First Posted: 2022-07-06

Condition(s): Tobacco Use, Tobacco Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation

Intervention(s): 300 mg Cannabidiol, 600 mg Cannabidiol, Placebo

Status: RECRUITING

Enrollment (expected or actual): 50

Allocation: RANDOMIZED

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): 2027-02-01

CT.gov Identifier: NCT05445804

Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.

First Posted: 2012-07-20

Condition(s): Idiopathic Parkinson's Disease

Intervention(s): Rotigotine, Placebo Patch, L-dopa

Status: COMPLETED

Enrollment (expected or actual): 346

Allocation: RANDOMIZED

Sponsor: UCB Pharma

Principal Investigator:

Completion Date (primary or actual): 2014-10

CT.gov Identifier: NCT01646255

A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome

This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011 in order to select 1 or 2 dose level(s) for further evaluation in the Phase 3 part of the study. In Phase 3, the primary objective was to assess the effect of RAD011 on hyperphagia-related behavior in participants with PWS.

First Posted: 2021-10-28

Condition(s): Prader-Willi Syndrome

Intervention(s): RAD011, Placebo

Status: TERMINATED

Enrollment (expected or actual): 4

Allocation: RANDOMIZED

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): 2022-10-31

CT.gov Identifier: NCT05098509

Transition From Acute to Chronic Back Pain : Effect of L-dopa,Gender,and Associated Brain Plasticity

This is a 6-month double-blinded, randomized, placebo-controlled clinical trial of pharmacological treatment (carbidopa/levodopa and celecoxib) for acute/subacute back pain. All eligible patients will be randomly assigned to 3 different group and receive a 12-week treatment of "carbidopa/levodopa+celecoxib ", of "placebo+celecoxib", and of "placebo+placebo". In addition, all participants will be MRI-scanned twice and assessed daily with a mobile app for pan, mood, and behavior.

First Posted: 2019-09-09

Condition(s): Chronic Back Pain

Intervention(s): carbidopa/levodopa and celecoxib, placebo1 and celecoxib, placebo1 and placebo2

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Principal Investigator:

Completion Date (primary or actual): 2023-12

CT.gov Identifier: NCT04082715

Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting

The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.

First Posted: 2008-03-25

Condition(s): Chemotherapy Induced Nausea and Vomiting

Intervention(s): dronabinol, ondansetron, dronabinol/ondansetron, placebo

Status: COMPLETED

Enrollment (expected or actual): 64

Allocation: RANDOMIZED

Sponsor: Solvay Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): 2004-07

CT.gov Identifier: NCT00642512

Dronabinol for Post-operative Pain After Lumbar Fusion

Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion

First Posted: 2020-04-15

Condition(s): Post-operative Pain

Intervention(s): Dronabinol 2.5mg Cap, Placebo

Status: UNKNOWN

Enrollment (expected or actual): 90

Allocation: RANDOMIZED

Sponsor: Jeffrey L Gum MD

Principal Investigator: Jeffrey L Gum MD, Attending Spine Surgeon

Completion Date (primary or actual): 2023-09-01

CT.gov Identifier: NCT04346407

Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis

The goal of this randomised, double-blind, placebo-controlled Phase II clinical trial is to assess the safety and effect of of IHL-675A in rheumatoid arthritis patients on pain, and function according to RAPID-3. 128 volunteers will be enrolled and randomised to one of four treatments (32 subjects per treatment). Each treatment will be self-administered twice daily for 24 weeks. The four treatments are: * Treatment 1 - IHL-675A * Treatment 2 - CBD * Treatment 3 - HCQ * Treatment 4 - Placebo

First Posted: 2023-07-12

Condition(s): Rheumatoid Arthritis

Intervention(s): IHL-675A, Cannabidiol, Hydroxychloroquine, Placebo

Status: TERMINATED

Enrollment (expected or actual): 20

Allocation: RANDOMIZED

Sponsor: Incannex Healthcare Ltd

Principal Investigator:

Completion Date (primary or actual): 2025-10-28

CT.gov Identifier: NCT05942911

The European Bifurcation Club Left Main Study

The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.

First Posted: 2015-07-14

Condition(s): Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Disease

Intervention(s): 1 Stent, 2 Stents

Status: UNKNOWN

Enrollment (expected or actual): 450

Allocation: RANDOMIZED

Sponsor: European Cardiovascular Research Center

Principal Investigator:

Completion Date (primary or actual): 2020-08

CT.gov Identifier: NCT02497014

A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)

A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach

First Posted: 2015-07-01

Condition(s): Parkinson's Disease

Intervention(s): Levodopa/Carbidopa (Sinemet)

Status: COMPLETED

Enrollment (expected or actual): 6

Allocation: NA

Sponsor: NeuroDerm Ltd.

Principal Investigator:

Completion Date (primary or actual): 2015-04

CT.gov Identifier: NCT02486432

Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)

This trial will evaluate the efficacy and safety of ZYN002, a clear cannabidiol gel that can be applied to the skin (called transdermal application) twice a day for the treatment of behavioral symptoms of Fragile X Syndrome (FXS). Eligible participants will then participate in up to a 14 week treatment period, where all participants will receive placebo or active study drug. Patients ages 3 to \< 18 years, will be eligible to participate.

First Posted: 2018-08-03

Condition(s): Fragile X Syndrome

Intervention(s): ZYN002 - Cannabidiol Transdermal Gel, Placebo Transdermal Gel

Status: COMPLETED

Enrollment (expected or actual): 212

Allocation: RANDOMIZED

Sponsor: Zynerba Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): 2020-06-14

CT.gov Identifier: NCT03614663

ADDICTAO: Psychological and Addictive Profile of Patients With Buerger's Disease

Background: Buerger's disease (thromboangiitis obliterans or TAO) is a rare disease (1/ 10 000) characterized by the development of segmental thrombotic occlusions of the medium and small arteries of the extremities. Afflicted patients are mostly young, male, inveterate tobacco (or cannabis) smokers who present with distal extremity ischemia, ischemic ulcers, of the toes or fingers. Large arteries are typically spared, as are the coronary, cerebral, and visceral circulations. Patients with TAO often suffer from severe ischemic pain and tissue loss culminating in minor and major limb amputation. Clinical diagnostic criteria generally include history of tobacco abuse; age of onset less than 50 years; infrapopliteal, segmental arterial occlusions with sparing of the proximal vasculature; frequent distal upper extremity arterial involvement (Raynaud's syndrome or digital ulceration); superficial phlebitis; and exclusion of arteriosclerosis, diabetes, true arteritis, proximal embolic source, and hypercoagulable states. While the cause of Buerger's disease remains unknown, the disease onset and clinical course are inextricably linked to tobacco (or cannabis) abuse. Tobacco abstinence generally results in disease quiescence and remains the mainstay of treatment. For some unknown reason, clinicians observed that TAO patients rarely discontinue smoking even though amputation is usually the inevitable consequence and the only method available of controlling pain and ulceration. Few studies were realized and Hofer-Mayer and coll. found remarkable personality features comparing to coronary patients: TAO patients significantly changed their place of work more often, had more absenteeism from work, smoked more before the illness and continued to smoke more frequently during their illness, were more often single or divorced and had more conflicts in their relationships. Those facts led us to explore their psychopathology and their addictive profile. Purpose: Search the prevalence of personality disorders in Buerger's patients who present with tobacco or cannabis smoking. Hypothesis: Patients with Buerger's disease show remarkable personality features (psychological and addictive profile) which are vulnerability factors to stop smoking (tobacco or cannabis) compared to patients with atheromatous arteritis.

First Posted: 2010-02-08

Condition(s): Thromboangiitis Obliterans, Atheromatous Arteritis

Intervention(s):

Status: COMPLETED

Enrollment (expected or actual): 224

Allocation:

Sponsor: University Hospital, Lille

Principal Investigator:

Completion Date (primary or actual): 2016-09

CT.gov Identifier: NCT01064206

Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth

when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. In this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol.

First Posted: 2021-01-22

Condition(s): Pulpitis - Irreversible

Intervention(s): Pulpotomy

Status: COMPLETED

Enrollment (expected or actual): 90

Allocation: RANDOMIZED

Sponsor: Ain Shams University

Principal Investigator: Rana sharaf, principle investigator

Completion Date (primary or actual): 2021-11-01

CT.gov Identifier: NCT04719247

Marijuana Approach Bias Retraining and Neural Response in Youth

This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham conditions. Substance use and cognitive assessment will identify changes in MJ use patterns and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance imaging marijuana cue reactivity task, we will determine differences in neural response in reward regions before and after 3 weeks of either AAT or sham treatment.

First Posted: 2016-03-30

Condition(s): Alcohol Approach/Avoidance Task, Sham Approach/Avoidance Task

Intervention(s): Marijuana Approach Avoidance Training

Status: COMPLETED

Enrollment (expected or actual): 41

Allocation: RANDOMIZED

Sponsor: Medical University of South Carolina

Principal Investigator:

Completion Date (primary or actual): 2017-10

CT.gov Identifier: NCT02723149

Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.

During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared. Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.

First Posted: 2020-10-30

Condition(s): Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Pain

Intervention(s): Cannabidiol Oil, Nimesulide

Status: UNKNOWN

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Pomeranian Medical University Szczecin

Principal Investigator: Dalewski Bartosz, Principal Investigator

Completion Date (primary or actual): 2021-12-31

CT.gov Identifier: NCT04609748

Interleukin-2 Treatment for Wiskott-Aldrich Syndrome

Funding Source--FDA OOPD. Orphan Product Grant Number--1R01FD004091-01A1 Context: Wiskott-Aldrich syndrome (WAS) is a fatal, devastating disease with ill-defined treatment modalities, which affects young boys. Classic WAS is characterized by a clinical triad of thrombocytopenia, eczema and severe, recurrent infections. Despite diagnostic and therapeutic advances most WAS patients die at less than 12 years of age due to infections, hemorrhage, malignancy or complications from treatments. WAS patients suffer from herpesvirus infections as a result of poor Natural Killer (NK) cell function (cytotoxicity). In the laboratory, the investigators have seen correction of WAS Natural Killer Cell (NK) function after treatment with Interleukin-2 (IL-2). Objectives: Initiate a prospective clinical trial by treating WAS subjects with IL-2 and using safety as the primary endpoint. Restoration of NK cell cytotoxicity and effects on cytoskeletal dynamics are secondary endpoints. The investigators will also observe patient clinical status (eczema, infections, use of treatment dose antibiotics, food allergies, etc). Study Design/Setting/Participants: This is a prospective clinical trial treating 9 WAS subjects in the Clinical Translational Research Center (CTRC) with IL-2. Intervention: The investigators propose to subcutaneously administer 0.5 Million Units (MU)/m2 of IL-2 daily to WAS subjects for 5 days. Research treatment will be repeated 2 and 4 months later. Inter-patient dose escalation will be employed to 1 MU/m2 and/or 2 MU/m2 based on safety as the primary endpoint. Study Measures: The investigators will observe safety and tolerability measures and perform assays on subject blood samples prior to and after research treatment to observe improvement in NK cell function.

First Posted: 2008-10-17

Condition(s): Wiskott-Aldrich Syndrome (WAS), X-linked Thrombocytopenia

Intervention(s): Interleukin-2

Status: COMPLETED

Enrollment (expected or actual): 9

Allocation: NA

Sponsor: Soma Jyonouchi

Principal Investigator: Soma Jyonouchi, Soma Jyonouchi,MD

Completion Date (primary or actual): 2016-09

CT.gov Identifier: NCT00774358

Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome

This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components (FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and meet the other inclusion/exclusion criteria. Following a 28-day baseline period, participants will begin an 84-day treatment period. Participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial. Following study completion, all participants will be invited to receive Cannabidiol Oral Solution in an open label extension study (under a separate protocol).

First Posted: 2014-12-17

Condition(s): Dravet Syndrome

Intervention(s): Cannabidiol Oral Solution, Placebo Solution

Status: WITHDRAWN

Enrollment (expected or actual): 0

Allocation: RANDOMIZED

Sponsor: INSYS Therapeutics Inc

Principal Investigator:

Completion Date (primary or actual): 2018-06-17

CT.gov Identifier: NCT02318563

Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain, and whether CBD effects levels of neuroinflammation. The efficacy of CBD use for low back pain treatment will also be evaluated by observing whether CBD administration will reduce neuroinflammation and low back pain symptoms.

First Posted: 2019-03-27

Condition(s): Back Pain, Low

Intervention(s): Cannabidiol

Status: TERMINATED

Enrollment (expected or actual): 7

Allocation: NA

Sponsor: Massachusetts General Hospital

Principal Investigator: Jodi Gilman, Associate Professor

Completion Date (primary or actual): 2020-11-23

CT.gov Identifier: NCT03891264

Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.

First Posted: 2019-03-25

Condition(s): Parkinson's Disease

Intervention(s): CVT-301, Sinemet

Status: COMPLETED

Enrollment (expected or actual): 23

Allocation: RANDOMIZED

Sponsor: Acorda Therapeutics

Principal Investigator:

Completion Date (primary or actual): 2019-06-28

CT.gov Identifier: NCT03887884

Chronic Cannabis Users: A Model for Negative Symptoms in Schizophrenia

The aim of the current study is set out to find a human model for negative symptoms based on clinical observation that chronic cannabis users express negative symptoms and characterize by the same neurocognitive and electrophysiology characteristics like patient suffer from schizophrenia. Towards that end the first part of the study is set out to explore weather chronic cannabis user's express negative symptoms similar to patient suffer from schizophrenia. The second part of the study will explore the neurocognitive and electrophysiology characteristics of those cannabis users that express negative symptoms. This data will be compared to parallel data of schizophrenia patients with predominantly negative symptom. Several lines of biological and genetic evidence support the cannabinoid hypothesis for schizophrenia. Particularly, it is most significant clinically that the possible involvement of the cannabinoid system in the neural basis for the negative symptoms. This hypothesis based on clinical findings that chronic cannabis use causes a combination of symptoms including apathy, avolition, lack of interest, passivity, and cognitive impairments, the so-called "amotivational syndrome," which resembles the core negative symptoms of schizophrenia in behavioral level as well as the brain level. Both are associated with the functions or integrity of the frontal lobe due to its role in creating self-directed behaviors, deficits in which may underlie alogia, anhedonia, and flat affect. Despite the aforementioned similarities, to date, there is no documentation for such a relationship. Recognition that chronic cannabis users share the same or similar constellation of symptoms and similar neurocognitive and electrophysiology characteristics could provide a key to develop a human model for negative symptoms and an essential tool to comprehensive understanding of the etiology of negative symptoms and development of an innovative therapy. The investigators Hypothesize That Chronic Cannabis Users Would Express the Same Constellation of Behaviors as Negative Symptoms of Schizophrenia; as well as similar neurocognitive and electrophysiology characteristics

First Posted: 2011-06-27

Condition(s): Chronic Cannabis Users, Healthy Subjects

Intervention(s): Magnetoencephalograph (MEG), Cambridge Neuropsychological Test Automated Battery (CANTAB)., Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)

Status: UNKNOWN

Enrollment (expected or actual): 115

Allocation: NON_RANDOMIZED

Sponsor: Shalvata Mental Health Center

Principal Investigator:

Completion Date (primary or actual): 2012-07

CT.gov Identifier: NCT01382433

Cannabinoids for Behavioral Problems in Children With ASD

This study aims to assess the safety, tolerability and efficacy of cannabinoids mix \[cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel\] for behavioral problems in children and youth with ASD.

First Posted: 2016-11-07

Condition(s): Autistic Disorder

Intervention(s): Cannabinoids - 99% pure cannabinoids mix, Placebo, Cannabinoids - whole plant extract

Status: COMPLETED

Enrollment (expected or actual): 150

Allocation: RANDOMIZED

Sponsor: Shaare Zedek Medical Center

Principal Investigator: Dr. Adi Aran, Director, Neuro-pediatric unit

Completion Date (primary or actual): 2018-12

CT.gov Identifier: NCT02956226

Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform enough cases to grasp this technique. The methods of ERCP training include hands-on teaching, training on different kinds of simulators, training on ex-vivo or live anesthetized porcine stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training. Selective cannulation is considered the most difficult and challenging part of learning ERCP. There is not an optimal time for trainees to attempt cannulation during hands-on ERCP training. The time used for attempting cannulation by trainees was 5min or 10min in several centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt cannulation for about one year. The incidence of post-ERCP pancreatitis, the major complication related to cannulation, was 4.0%, which was comparable with previous studies. The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation would increase success rate of selective cannulation and help to improve skills more quickly. At the meantime, with actively verbal or hands-on assistance from the instructor during performance of trainees, the risk of complications would not increased with a longer time to attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study was designed to evaluate the effects of different periods of time for trainees to attempt selective cannulation on success rate of cannulation, self-satisfaction of performance and post-ERCP pancreatitis.

First Posted: 2013-05-10

Condition(s): Disease as Reason for ERCP

Intervention(s): Hands-on ERCP training.

Status: COMPLETED

Enrollment (expected or actual): 256

Allocation: RANDOMIZED

Sponsor: Air Force Military Medical University, China

Principal Investigator: Yanglin Pan, Associated professor

Completion Date (primary or actual): 2013-12

CT.gov Identifier: NCT01851226

The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Coronavirus Disease 2019 (COVID-19)

The aim this study is to investigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 .

First Posted: 2021-07-29

Condition(s): Covid19

Intervention(s): Nigella Sativa capsule twice daily

Status: UNKNOWN

Enrollment (expected or actual): 100

Allocation: RANDOMIZED

Sponsor: Ain Shams University

Principal Investigator:

Completion Date (primary or actual): 2021-12-30

CT.gov Identifier: NCT04981743

Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

The purpose of this study is to determine if an eye tracking impairment sensor can detect cannabis-induced impairment after using cannabis.The overall objective is to correlate measures collected from the eye tracking sensor with measures related to cannabis impairment (e.g., plasma THC levels, self-reported cannabis subjective effects, cognitive effects).

First Posted: 2019-06-21

Condition(s): Cannabis Intoxication

Intervention(s): Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye, Cannabis cigarette - 4.0% THC

Status: TERMINATED

Enrollment (expected or actual): 3

Allocation: NA

Sponsor: Battelle Memorial Institute

Principal Investigator:

Completion Date (primary or actual): 2020-03-13

CT.gov Identifier: NCT03994926

Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Carbidopa

The purpose of this study is to the effect of three single oral doses of nebicapone (50 mg, 100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa 200 mg/carbidopa 50 mg (Sinemet CR 200/50).

First Posted: 2016-05-17

Condition(s): Parkinson's Disease

Intervention(s): BIA 3-202, Placebo, Sinemet®

Status: COMPLETED

Enrollment (expected or actual): 16

Allocation: RANDOMIZED

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): 2005-11

CT.gov Identifier: NCT02774564

SV2 PET Imaging With [11C]APP311

The aim of this study is to evaluate a new SV2A tracer, \[11C\]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.

First Posted: 2019-06-21

Condition(s): Schizophrenia and Other Psychotic Disorders, Cannabis Use Disorder, Healthy

Intervention(s): [11C]APP311

Status: ACTIVE_NOT_RECRUITING

Enrollment (expected or actual): 250

Allocation:

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Professor of Psychiatry

Completion Date (primary or actual): 2026-12

CT.gov Identifier: NCT03995121

A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup

A hybrid effectiveness-implementation trial that is designed to assess the effectiveness of an intervention (The Teen Marijuana Check-Up) when delivered in real world settings. In addition, the study will assess the frequency of coaching support needed by providers to maintain adherent skill levels.

First Posted: 2017-04-13

Condition(s): Cannabis Use

Intervention(s): Teen Marijuana Check Up, Treatment as Usual, Gold Standard Coaching, As Needed Coaching

Status: COMPLETED

Enrollment (expected or actual): 264

Allocation: RANDOMIZED

Sponsor: University of Washington

Principal Investigator: Denise Walker, Research Associate Professor

Completion Date (primary or actual): 2023-02-28

CT.gov Identifier: NCT03111667

Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants

Urinary tract infections are common in infants. Obtaining urine from pre-continent children can be difficult and time consuming. The method of collection must balance reliability, speed, low rate of contamination, and invasiveness. According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infections. However, it is impractical in pre-continent children. Recently, two quick, safe and effective methods have been reported in the literature: * The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines. * The bladder stimulation method : the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively. However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.

First Posted: 2020-10-14

Condition(s): Urinary Tract Infections

Intervention(s): bladder stimulation, Quick wee

Status: COMPLETED

Enrollment (expected or actual): 230

Allocation: RANDOMIZED

Sponsor: Fondation Lenval

Principal Investigator:

Completion Date (primary or actual): 2022-11-17

CT.gov Identifier: NCT04587999

Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain

The purpose of this research study is to determine if Marinol alleviates pain in patients with chronic pain who are currently taking opioids. The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and complete surveys relating to pain. During the first visit a brief examination and a few surveys about pain, quality of life, and medical history are given. The study doctor then determines if the participant continues to qualify for the study. If qualified for the study, patients receive a daily diary to record pain levels and pain medications; this will take about 5 minutes each day. After completion of the diary, patients begin the 8-hour visits. Patients visit the Pain Trials Center three times to receive study medication. After taking the study medication, participants remain in the clinic for 8 hours to complete hourly surveys about pain and pain relief. Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at home, and pain levels are recorded in a diary. Participants can change the dose of study drug to better control pain and side effects, after speaking with study staff. The study then concludes with a final 30-minute visit to summarize the participant's experience in the clinical trial.

First Posted: 2005-09-12

Condition(s): Chronic Pain

Intervention(s): Marinol (dronabinol)

Status: COMPLETED

Enrollment (expected or actual): 30

Allocation: RANDOMIZED

Sponsor: Brigham and Women's Hospital

Principal Investigator: Sanjeet Narang, Instructor in Anesthesia, Harvard Medical School

Completion Date (primary or actual): 2006-04

CT.gov Identifier: NCT00153192

Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome

The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1 blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects with Prader-Willi Syndrome (PWS). This will be a double blind placebo controlled clinical trial involving a total of 18 young adults aged 18 to 35 years with PWS. Patients will be divided in to the two groups of control and intervention, and treated with either placebo (inactive drug), or rimonabant 20 mg once a day for a total duration of 6 months. Body weight, fat distribution, objective and subjective assessment of the hunger, fasting blood sample for measurement of ghrelin and leptin (two hormones regulating appetite), serum lipids , IGF-1(growth hormone related protein), insulin and glucose concentrations will be measured upon enrollment, at 3 months, and at the end of the study. The proportion of body fat to muscle will be determined using a radiological technique, whole body dual-energy x-ray absorptiometry (DEXA) scan, and also by measurement of skin fold thickness, waist and hip circumference at the enrollment prior to the intervention, and at the end of the study.

First Posted: 2008-01-28

Condition(s): Prader-willi Syndrome

Intervention(s): rimonabant, placebo

Status: TERMINATED

Enrollment (expected or actual): 10

Allocation: RANDOMIZED

Sponsor: Weill Medical College of Cornell University

Principal Investigator:

Completion Date (primary or actual): 2009-01

CT.gov Identifier: NCT00603109

Systematically Testing the Evidence on Marijuana

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