Systematically Testing the Evidence on Marijuana

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: April 12, 2022

Condition(s): Anxiety, Epilepsy

Intervention(s): Cannabidiol 100 MG/ML

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: N/A

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Principal Investigator: Jay Salpekar, M.D., Principal Investigator

Completion Date (primary or actual): April 4, 2025

CT.gov Identifier: NCT05324449

The purposes of this study are 1) to determine if the administration of different low doses of CBD (5 mg, 17 mg, 50 mg and 100 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose CBD is associated with effects that are not detected with the available research tools.

First Posted: April 11, 2022

Condition(s): Cannabis

Intervention(s): Cannabis, placebo

Status: Not yet recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

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

Principal Investigator:

Completion Date (primary or actual): August 2023

CT.gov Identifier: NCT05320367

The overarching goal of this online study is to compare the efficacy of six (weekly) sessions of Domain-Specific Episodic Future Thinking (DS-EFT) relative an active control condition on improving the ability to value future rewards and reducing cannabis use (grams and days of use), tobacco use, and alcohol use among.

First Posted: April 12, 2022

Condition(s): Marijuana Use, Marijuana Dependence, Tobacco Use, Alcohol Use, Unspecified

Intervention(s): Domain-Specific Episodic Future Thinking

Status: Recruiting

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Michael Sofis

Principal Investigator: Michael Sofis, Senior Scientist

Completion Date (primary or actual): July 2022

CT.gov Identifier: NCT05324813

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, 35 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: April 8, 2022

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol

Status: Recruiting

Enrollment (expected or actual): 35

Allocation: Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: Lindsay Squeglia, Associate Professor

Completion Date (primary or actual): July 2024

CT.gov Identifier: NCT05317546

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: May 31, 2022

Condition(s): Cannabis Use

Intervention(s): Contingency Management

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: N/A

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): December 2023

CT.gov Identifier: NCT05396638

This study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes. The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism. These tests will be performed prior to start of treatment and again after 2-weeks of treatment with the THC or placebo.

First Posted: April 11, 2022

Condition(s): Type 2 Diabetes

Intervention(s): THC, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Jeremy Pettus, MD, Principal Investigator

Completion Date (primary or actual): April 30, 2026

CT.gov Identifier: NCT05322213

The concerning lack of research related to technology-based psychological interventions in individuals with psychosis and cannabis use disorder (CUD) led to the design a randomized control trial (RCT) with an innovative mobile health e-intervention called ICanChange (iCC). Randomized control trials (RCTs) on well-defined samples (limited to psychosis and CUD) are needed to generate evidence on e-health interventions in individuals with psychosis and CUD. As such, an RCT will be conducted to assess the acceptability and feasibility of administering this e-intervention to young people with psychosis who use cannabis. Besides having scarce cannabis interventions adapted for people with psychosis, there are other barriers to addressing problematic cannabis use, such as the challenging and inadequate access to mental health and substance use services by this population. Implementing these and other approaches in the context of a harm reduction intervention or applying other strategies seeking to minimize cannabis-related harms for people who wish to continue using cannabis may be key in helping individuals set realistic goals that are important and relevant to them.

First Posted: April 5, 2022

Condition(s): Cannabis Use Disorder

Intervention(s): iCanChange

Status: Enrolling by invitation

Enrollment (expected or actual): 100

Allocation: Randomized

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

Principal Investigator:

Completion Date (primary or actual): March 31, 2024

CT.gov Identifier: NCT05310981

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: April 4, 2022

Condition(s): Cannabis Use, Marijuana Use

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

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation:

Sponsor: Ottawa Hospital Research Institute

Principal Investigator:

Completion Date (primary or actual): June 2023

CT.gov Identifier: NCT05309226

Fibromyalgia is a syndrome characterized by widespread chronic pain involving all musculoskeletal systems, accompanied by chronic sleep disorders, fatigue, memory problems, and more. Despite the advancement in the understanding of pain mechanisms thanks to various innovations in neuroscience and pain medicine, the syndrome's treatments are not satisfying, even in the presence of optimal multidisciplinary therapy, and many patients continue to suffer from chronic pain and associated symptoms. Although the pathophysiology of Fibromyalgia is not fully understood, there is evidence supporting the involvement of several mechanisms, including central sensitization, descending pain modulation pathway deficiency, and autonomic dysfunction, confirmed by physiological and functional imaging studies. Following the above reasons, there is great importance in understanding the effect of new treatments on pain mechanisms in Fibromyalgia syndrome. In the past few years, more and more research is providing evidence for cannabis analgesia in chronic pain syndromes, with an emphasis on Tetrahydrocannabinol (THC). However, only a little research has examined its efficacy in random double-blind experiments. Thus, testing the effect of THC in experimental clinical pain models could give a hint to our understanding of the pain regulation system in Fibromyalgia. The current research will study the effects of the cannabinoid THC component on pain regulation in Fibromyalgia in a double-blind controlled design. For that matter, the investigators will perform different peripheral physiological tests and functional magnetic resonance imaging. Additionally, the investigators aim to disclose the neural mechanisms underlying pain-autonomic interactions in Fibromyalgia patients.

First Posted: December 9, 2022

Condition(s): Fibromyalgia, Primary

Intervention(s): Cannabis oil

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Tel Aviv Medical Center

Principal Investigator: yara agbaria, researcher

Completion Date (primary or actual): April 2024

CT.gov Identifier: NCT05644054

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: May 10, 2022

Condition(s): Coronary Artery Disease

Intervention(s): Balloon dilation

Status: Recruiting

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): December 30, 2022

CT.gov Identifier: NCT05368129

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: April 1, 2022

Condition(s): HIV Seropositivity

Intervention(s): CBD LGP 50, Placebo

Status: Recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Centre Hospitalier Régional d'Orléans

Principal Investigator:

Completion Date (primary or actual): February 18, 2023

CT.gov Identifier: NCT05306249

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: Multiple rTMS sessions can reduce craving for cannabis, severity of CUD, frequency and amount of cannabis use. Different rTMS treatment schedules have differences in reducing the craving for cannabis and severity of CUD, and prolonging relapse of cannabis use.

First Posted: March 23, 2022

Condition(s): Cannabis Use Disorder, Repetitive Transcranial Magnetic Stimulation

Intervention(s): Repetitive Transcranial Magnetic Stimulation

Status: Not yet recruiting

Enrollment (expected or actual): 18

Allocation: Randomized

Sponsor: The University of Hong Kong

Principal Investigator:

Completion Date (primary or actual): January 1, 2026

CT.gov Identifier: NCT05292547

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 to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.

First Posted: March 24, 2022

Condition(s): Tobacco Use Disorder, Cannabis Use Disorder

Intervention(s): Varenicline, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 138

Allocation: Randomized

Sponsor: VA Office of Research and Development

Principal Investigator:

Completion Date (primary or actual): December 31, 2025

CT.gov Identifier: NCT05294263

This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce opioid use, anxiety, and pain and improve sleep and cognitive function. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

First Posted: March 29, 2022

Condition(s): Opioid Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 150

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): February 2027

CT.gov Identifier: NCT05299944

The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants.

First Posted: March 18, 2022

Condition(s): Behavioral Pharmacology of Cannabis

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

Status: Recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): June 1, 2025

CT.gov Identifier: NCT05287256

Fibromyalgia is considered a chronic pain syndrome, non-inflammatory, of unknown etiology, which manifests itself in the musculoskeletal system in up to 2.5% of the general population, predominantly in females, mainly between 35 and 44 years old, having a direct impact on the quality of life of their patients (JUNIOR; GOLDENFUM; SIENA, 2012; HEYMANN et al., 2017). In 1990, eighteen (18) specific sites were defined as tender points which are used to better diagnose fibromyalgia (WOLFE et al., 2010). Due to its clinical and exclusion diagnosis, treatment usually starts late, which allows the progression of symptoms and corroborates its low efficiency in the long term (DE SOUSA BRAZ et al., 2011). Due to the ineffective results and significant side effects that conventional treatment with drugs such as antidepressants, analgesics and anti-inflammatory drugs can provide, patients, physicians and researchers are looking for new main or adjuvant treatments, pharmacological and non-pharmacological (DE SOUSA BRAZ et al. al., 2011). In this context, it has been seen that the use of Cannabis sativa as a therapeutic option in fibromyalgia is promising, especially in reducing the pain caused by the disease and also the adjuvant symptoms, such as depression and sleep disorders (YASSIN; ORON; ROBINSON, 2019). This result must occur due to the action of cannabinoids, such as CBD and THC, on cannabinoid receptors distributed in peripheral nerves, spinal cord and supraspinal region, sites responsible for the reception, transmission and perception of pain (STE-MARIE et al., 2012). Currently, cannabinoids are considered safe analgesics with considerable efficacy, which demonstrates potential as a therapeutic option in the treatment of chronic pain, particularly in patients refractory to other treatments (HAUSER et al., 2018). In addition to its action on the painful mechanisms of fibromyalgia, the antidepressant effects of Cannabis are of great value in the treatment of fibromyalgia. These effects are explained by the modulation on serotonin 5-HT1A receptors, which has its effect exerted especially by CBD (ESPEJO-PORRAS et al., 2013). Considering that research has reported the effects of phytocannabinoids on the painful symptoms of fibromyalgia (HAUSER et al., 2018), the hypotheses of the present study are: Primary hypothesis: The dose-response curve and ED50 for the primary outcome, which is related to pain intensity, will be determined in the dose range between 0.1 and 10mg/day. The sensation of pain will be significantly reduced in participants receiving oral solution containing CBD/THC 10mg/day compared to those who will receive placebo. Secondary hypothesis: There will be a reduction in pain catastrophizing, as well as an improvement in the acceptance and action rate related to pain, a reduction in depression, an improvement in sleep latency and quality, a reduction in insomnia and an increase in the quality of life in patients treated with oral solution containing CBD/THC 10mg/day compared to those receiving placebo. Supporting Hypothesis: The tested CBD/THC solution will show efficacy and safety with no serious adverse effects.

First Posted: March 16, 2022

Condition(s): Fibromyalgia

Intervention(s): cannabidiol and tetrahydrocannabinol, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: FG Brasil LTDA

Principal Investigator:

Completion Date (primary or actual): August 20, 2022

CT.gov Identifier: NCT05283161

To examine the extent to which Cannabidiol (CBD) enhances fear conditioning extinction in college undergraduates who show elevated social anxiety. Undergraduates who display elevated social anxiety on standard assessments will be recruited at the University of Connecticut. All participants will be put in a standard fear conditioning paradigm where they are conditioned to fear a face that occasionally is followed by a shock to their wrist. The other face never is paired with a shock. After everybody learns this, half of the participants will receive 600 mg CBD Isolate Gel Capsules one time, and the other half will receive a placebo dose. Participants will then be presented with the faces with no shocks, and the rate and duration of extinction as measured by electrodermal response as well as subjective fear ratings via a visual analogue scale will be examined. It is hypothesized that participants that receive CBD will display enhanced extinction compared to the placebo group, as evidenced by reduced electrodermal response and reduced visual analogue fear ratings.

First Posted: March 17, 2022

Condition(s): Anxiety and Fear

Intervention(s): Cannabidiol Oral Product, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 160

Allocation: Randomized

Sponsor: University of Connecticut

Principal Investigator: Robert Astur, Associate Professor

Completion Date (primary or actual): December 2022

CT.gov Identifier: NCT05283382

While many empirical projects have described multiple potential health benefits of CBD, the potential for CBD to provide protection against the development of diabetes via favorable modification of the gut microbiota has received relatively less attention. We hope to learn if CBD can improve glucose tolerance and the gut microbiota, and if these two improvements might be related.

First Posted: March 17, 2022

Condition(s): Diabetes

Intervention(s): Cannabidiol (CBD) powder formulation, Matching Placebo Cannabidiol (CBD) powder formulation

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Christopher Bell

Principal Investigator: Christopher Bell, Associate Professor

Completion Date (primary or actual): March 9, 2023

CT.gov Identifier: NCT05285449

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 then be used to determine if the weaning protocol is useful and help the study team design a larger randomized controlled trial.

First Posted: April 28, 2022

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

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

Status: Recruiting

Enrollment (expected or actual): 51

Allocation: Randomized

Sponsor: University Health Network, Toronto

Principal Investigator: Jo Carroll, Research Manager

Completion Date (primary or actual): May 2023

CT.gov Identifier: NCT05351905

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: March 11, 2022

Condition(s): Cannabis

Intervention(s): Cannabis(THC) inhaled

Status: Recruiting

Enrollment (expected or actual): 75

Allocation: Non-Randomized

Sponsor: ISBRG Corp

Principal Investigator:

Completion Date (primary or actual): August 2022

CT.gov Identifier: NCT05276232

The overarching aim of this study is to examine the impact of acute cannabis and alcohol administration on driving performance, as well as identify methods for detecting driving under the influence of these substances. One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and tetrahydrocannabinol (THC), 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo. Cannabis inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid/saliva, breath) over the subsequent 4 hours after ingestion. The purpose of this study is to determine (1) the impact of Δ9-THC on driving performance with and without concurrent alcohol ingestion (2) the duration of driving impairment in terms of hours from initial use, (3) the relationship between performance on the DRE measures and cannabis/alcohol ingestion, and 4) if saliva or expired air can serve as a useful adjunct to the field for blood sampling.

First Posted: March 10, 2022

Condition(s): Driving Impaired, Alcohol Intoxication, Driving Under the Influence, Cannabis Intoxication

Intervention(s): Cannabis, Alcohol

Status: Not yet recruiting

Enrollment (expected or actual): 125

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Thomas D. Marcotte, PhD, Professor

Completion Date (primary or actual): June 2023

CT.gov Identifier: NCT05273658

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: March 10, 2022

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: Not yet recruiting

Enrollment (expected or actual): 334

Allocation: Randomized

Sponsor: LaSanta S A S

Principal Investigator:

Completion Date (primary or actual): February 15, 2024

CT.gov Identifier: NCT05272865

The primary purpose of this study is to investigate the effect of guanfacine-ER on reductions in cannabis use and explore its effects on impulsivity and withdrawal through a hybrid in-person and virtual trial of treatment-seeking individuals with Cannabis Use Disorder (CUD), and assessing the feasibility of the virtual components of the study.

First Posted: March 10, 2022

Condition(s): Cannabis Use

Intervention(s): guanfacine-ER, Placebo

Status: Recruiting

Enrollment (expected or actual): 90

Allocation: Randomized

Sponsor: New York State Psychiatric Institute

Principal Investigator: Christina Ann Brezing, Assistant Professor of Psychiatry

Completion Date (primary or actual): March 2025

CT.gov Identifier: NCT05273567

The purpose of this research study is to compare the effects of cannabidiol (CBD), tetrahydrocannabinol (THC), or both, on sleep and pain in persons with multiple sclerosis (MS). Little is known about how CBD and/or THC may help sleep, reduce pain, or perhaps even treat pain through better sleep.

First Posted: March 8, 2022

Condition(s): Multiple Sclerosis, Sleep, Pain

Intervention(s): Cannabidiol (CBD), Tetrahydrocannabinol (THC), Placebo CBD, Placebo THC

Status: Recruiting

Enrollment (expected or actual): 166

Allocation: Randomized

Sponsor: Tiffany J. Braley, MD, MS

Principal Investigator: Tiffany J. Braley, MD, MS, Associate Professor of Neurology

Completion Date (primary or actual): June 2026

CT.gov Identifier: NCT05269628

Double-blind placebo controlled study of Cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure(TM) Formulation (Nantheia ATL5(TM)). Subjects complete 3 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, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched comparison subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).

First Posted: March 8, 2022

Condition(s): PTSD

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

Status: Not yet recruiting

Enrollment (expected or actual): 180

Allocation: Randomized

Sponsor: University of Nebraska

Principal Investigator: Matthew Rizzo, Professor

Completion Date (primary or actual): May 2027

CT.gov Identifier: NCT05269459