Search Results (1969)
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Studying the Effects of Cannabis on Vasculature
Cannabis is commonly used globally. It is associated with psychiatric problems, but the effects on the cardiovascular system are unclear. In this project, the investigators plan to study the effects of cannabis on the cardiovascular system. This will be done by using a non-invasive test to measure blood vessel function and by using blood samples to measure inflammation. As a control for this project, the investigators would like to test the blood vessel function and inflammation levels of participants who do not use cannabis. This study will provide important information on the long term cardiovascular effects of cannabis.
First Posted: October 14, 2022
Condition(s): Cardiovascular Diseases, Inflammation, Atherosclerosis
Intervention(s): Chronic Cannabis use
Status: Not yet recruiting
Enrollment (expected or actual): 100
Allocation:
Sponsor: Lawson Health Research Institute
Principal Investigator: Mark Chandy, Assistant Professor
Completion Date (primary or actual): June 2023
Inflammatory Bowel Diseases (IBD) Cannabis Registry
The inflammatory bowel diseases (IBDs), ulcerative colitis (UC) and Crohn's disease (CD), are characterized by lifelong relapsing-remitting gastrointestinal inflammation, with symptoms of abdominal pain, diarrhea, and rectal bleeding during active disease. Medical therapy reduces intestinal inflammation and ameliorates symptoms. Medical cannabis has recently been added to the arsenal of symptom-reducing measures in IBD. Though the efficacy of THC and CBD have been established as the two most dominant ingredients of cannabis, the rest of the plant phytochemicals are unknown, and effects on patients are not yet determined.
First Posted: October 13, 2022
Condition(s): Crohn Disease, Ulcerative Colitis, Pouchitis, Healthy
Intervention(s): Medical Cannabis
Status: Recruiting
Enrollment (expected or actual): 1000
Allocation:
Sponsor: Eli Sprecher, MD
Principal Investigator: Eli Sprecher, MD, PI
Completion Date (primary or actual): July 10, 2023
Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
The R61 will include two CBD dose levels vs placebo (PBO) and examine potential engagement with two primary targets in a 3-week randomized controlled trial design. Willing and eligible subjects will be randomized to one of three randomized double-blind treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice daily), 2) CBD 400 mg (200 mg twice daily), or 3) PBO twice daily for three weeks.
Participation is estimated at approximately 1 month from end of screening to endpoint for the primary R61 study period. This includes screening, baseline, week 2 stress task, Week 3 2-day imaging paradigm, and clinical safety assessments at weeks 2 and 3.
First Posted: October 7, 2022
Condition(s): Social Anxiety Disorder
Intervention(s): Cannabidiol, Placebo
Status: Recruiting
Enrollment (expected or actual): 60
Allocation: Randomized
Sponsor: NYU Langone Health
Principal Investigator:
Completion Date (primary or actual): August 1, 2024
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: October 3, 2022
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): November 30, 2028
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 THC (tetrahydrocannabinol) and CBD (cannabidiol) in medical cannabis impact neuropathic pain, inflammation and adverse events.
First Posted: September 26, 2022
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: Recruiting
Enrollment (expected or actual): 100
Allocation: Randomized
Sponsor: Montefiore Medical Center
Principal Investigator:
Completion Date (primary or actual): March 31, 2024
Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
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 improve cognition and traumatic brain injury-related symptoms. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
First Posted: November 30, 2022
Condition(s): Brain Injuries, Traumatic
Intervention(s): Cannabidiol, Placebo
Status: Recruiting
Enrollment (expected or actual): 120
Allocation: Randomized
Sponsor: University of Colorado, Denver
Principal Investigator:
Completion Date (primary or actual): December 15, 2025
CANnabinoids in Pediatric ONCology
CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.
First Posted: March 6, 2023
Condition(s): Childhood Cancer, Cancer
Intervention(s): MPL-001, MPL-005, MPL-009
Status: Not yet recruiting
Enrollment (expected or actual): 60
Allocation: Randomized
Sponsor: University of Manitoba
Principal Investigator:
Completion Date (primary or actual): December 2025
Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
This clinical trial tests how well phytocannabinoids (cannabidiol [CBD] and tetrahydrocannbinol [THC]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.
First Posted: January 5, 2023
Condition(s): Breast Carcinoma, Chemotherapy-Induced Peripheral Neuropathy, Colon Carcinoma
Intervention(s): Cannabidiol, Delta-8-Tetrahydrocannabinol, Placebo Administration, Questionnaire Administration
Status: Not yet recruiting
Enrollment (expected or actual): 120
Allocation: Randomized
Sponsor: City of Hope Medical Center
Principal Investigator:
Completion Date (primary or actual): October 31, 2024
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: October 4, 2022
Condition(s): Cannabis Use
Intervention(s): CT-MICART App, Control
Status: Recruiting
Enrollment (expected or actual): 50
Allocation: N/A
Sponsor: University of Houston
Principal Investigator: Lorra Garey, Principal Investigator
Completion Date (primary or actual): October 23, 2023
Pilot Study of MC in Paediatric Palliative Care
The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial.
Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.
First Posted: November 14, 2022
Condition(s): Palliative Care
Intervention(s): Medicinal Cannabis - C12T12, Medicinal Cannabis - C20T5
Status: Not yet recruiting
Enrollment (expected or actual): 10
Allocation: Randomized
Sponsor: Murdoch Childrens Research Institute
Principal Investigator:
Completion Date (primary or actual): February 2024
CBD, Nutrient Metabolism and Energy Intake
CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal. Healthy, adult volunteers will complete two conditions in a crossover design, comparing outcomes following both CBD and placebo supplementation.
First Posted: November 16, 2022
Condition(s): Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorders, Appetitive Behavior
Intervention(s): Acute oral CBD supplementation, Acute oral placebo supplementation
Status: Active, not recruiting
Enrollment (expected or actual): 15
Allocation: Randomized
Sponsor: Loughborough University
Principal Investigator: Lewis James, Senior Lecturer in Nutrition
Completion Date (primary or actual): March 30, 2022
Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes
Co-administration of cannabis and tobacco is a common practice, but there is little experimental evidence aimed at understanding the reasons for this prevalence. Some preliminary evidence suggests that tobacco may actually counteract the cognitive-impairing effects of cannabis, and may also increase the subjective ('liking') effects of cannabis, but results are inconclusive. Further, there are no studies into the effects of tobacco on other cannabis-related harms such as driving, or on the ability of tobacco to alter the blood levels of THC, the chemical responsible for the psychoactive properties of cannabis. The purpose of the present study will be to evaluate the effects of tobacco, cannabis or combinations of tobacco and cannabis on driving, cognition, subjective effects and blood THC. Driving will be assessed using a state-of-the-art driving simulator that allows for the safe and objective measurement of the effects of intoxicating substances on driving. Participants will be regular users of cannabis and will be invited to the lab for four counterbalanced test sessions. In these test sessions they will drive the simulator and undergo cognitive tests before and after smoking: 1) cannabis; 2) tobacco; 3) cannabis + tobacco; or 4) placebo. Outcomes will be measured at several time points after smoking the product. Participants will also give blood for determination of levels of THC, and will complete subjective effects questionnaires both before and after smoking the cigarette. This study will be one of the first experimental laboratory studies of the reasons behind co-administration of tobacco and cannabis.
First Posted: September 2, 2022
Condition(s): Driving Under the Influence
Intervention(s): Cannabis, Tobacco, Cannabis tobacco, Placebo
Status: Not yet recruiting
Enrollment (expected or actual): 60
Allocation: Non-Randomized
Sponsor: Centre for Addiction and Mental Health
Principal Investigator:
Completion Date (primary or actual): February 1, 2027
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
This NIH funded study will enroll 20 pregnant women in an Open Trial and 50 pregnant women in an RCT who are at high risk for prenatal cannabis use. Participants will be assigned to either: (1) a 12-week Lifestyle Physical Activity plus Fitbit (LPA+Fitbit) intervention or (2) a Fitbit Only condition. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.
First Posted: September 6, 2022
Condition(s): Pregnancy, Cannabis
Intervention(s): LPA+Fitbit intervention, Fitbit Only
Status: Recruiting
Enrollment (expected or actual): 70
Allocation: Randomized
Sponsor: Butler Hospital
Principal Investigator:
Completion Date (primary or actual): May 2025
Regulated Cannabis Access in Basel
The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.
First Posted: August 30, 2022
Condition(s): Cannabis Use Disorder, Mental Health Disorder, Physical Illness
Intervention(s): Regulated cannabis access in pharmacies
Status: Active, not recruiting
Enrollment (expected or actual): 374
Allocation: Randomized
Sponsor: Health Department of the Canton of Basel-Stadt
Principal Investigator: Marc Walter, Prof. Dr. med.
Completion Date (primary or actual): July 31, 2025
Feasibility and Acceptability of the Cannabis Awareness and Prevention Toolkit
The Stanford Tobacco Prevention Toolkit is a free, online Toolkit that consists of a curriculum, educational resources, and a resource directory to be used by educators, parents, juvenile justice workers, and healthcare providers to increase knowledge and awareness of cannabis and reduce use among youth. 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: August 30, 2022
Condition(s): Cannabis Use
Intervention(s): Stanford Cannabis Awareness and Prevention curriculum
Status: Enrolling by invitation
Enrollment (expected or actual): 600
Allocation: Randomized
Sponsor: Stanford University
Principal Investigator: Bonnie Halpern-Felsher, Marron and Mary Elizabeth Kendrick Professor in Pediatrics II
Completion Date (primary or actual): December 20, 2023
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: August 29, 2022
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): October 30, 2025
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: August 29, 2022
Condition(s): Melanoma
Intervention(s): High-performance liquid chromatography-tandem mass spectrometry assays
Status: Recruiting
Enrollment (expected or actual): 90
Allocation:
Sponsor: University of Colorado, Denver
Principal Investigator:
Completion Date (primary or actual): August 31, 2024
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.
First Posted: August 25, 2022
Condition(s): HIV, Cannabis, THC, Neuroinflammatory Disease, Neuroinflammatory Response, Microbiome
Intervention(s): THC, CBD
Status: Recruiting
Enrollment (expected or actual): 100
Allocation: Randomized
Sponsor: University of California, San Diego
Principal Investigator: Ronald Ellis, Principal Investigator
Completion Date (primary or actual): October 31, 2027
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract < 0.08% THC (FEN164) in children with Autism Spectrum Disorder.
First Posted: August 25, 2022
Condition(s): Autism Spectrum Disorder
Intervention(s): FEN164
Status: Active, not recruiting
Enrollment (expected or actual): 18
Allocation: N/A
Sponsor: Fenix Innovation Group
Principal Investigator:
Completion Date (primary or actual): September 1, 2022
Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)
Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs.
The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.
First Posted: August 16, 2022
Condition(s): Malnutrition, Anorexia, Cannabis, Aging, Emergency Service, Hospital, Renal Function, Pharmacokinetics
Intervention(s): Sativex
Status: Recruiting
Enrollment (expected or actual): 17
Allocation: Randomized
Sponsor: Ove Andersen
Principal Investigator: Ove Andersen, Research Director and Head of the Department of Clinical Research
Completion Date (primary or actual): August 1, 2023
Characterization of the Pattern of Consumption and Withdrawal Syndrome From Dual Cannabis and Tobacco Use
Aims: To characterize the pattern of cannabis and tobacco use and withdrawal symptoms in people who start treatment for cannabis use disorders (exclusive cannabis, concurrent and/or simultaneous with various tobacco products) through an aplication game and considering the type of users. Methodology: Mixed-methods research composed of three studies. Study I: qualitative participatory action study aimed at exploring the experiences and preferences of the cannabis users on the use of apps. This information will be instrumental in the co-design of the app. Study II: prospective longitudinal study aimed to establish consumption patterns and transitions between substances and to validate the scale of cannabis withdrawal symptoms in the Spanish population. Sample size: expected RR=1.20, α =0.05, β= 0.20, losses= 20% (n=282). Study III: qualitative study to explore participants' experiences during the process of quitting cannabis and / or tobacco. Expected results: Characterization and prediction of variables that influence cannabis and tobacco cessation/ reduction and describe withdrawal symptoms according to consumption patterns with aim of improving the design of future interventions.
First Posted: August 23, 2022
Condition(s): Cannabis Dependence, Tobacco Use, Withdrawal Syndrome, Substance Abuse
Intervention(s):
Status: Not yet recruiting
Enrollment (expected or actual): 282
Allocation:
Sponsor: Cristina Martínez Martínez
Principal Investigator: Cristina Martínez Martínez, Principal Investigator
Completion Date (primary or actual): December 2024
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: August 10, 2022
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): August 21, 2023
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: October 3, 2022
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: Recruiting
Enrollment (expected or actual): 30
Allocation: Randomized
Sponsor: Medical University of Silesia
Principal Investigator:
Completion Date (primary or actual): July 30, 2023
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: August 11, 2022
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): January 27, 2022
Acute Effects of Cannabis on Everyday Life Memory
This study will examine the acute effects of cannabis on various aspects of memory. Eligible participants will complete a drug screen. Participants who pass the drug screen will be asked to wear an Empatica E4 wristband for the duration of the study. Participants will provide a saliva sample from which cortisol will be extracted. They will then complete baseline measures of cannabis consumption patterns, level of intoxication, mood, anxiety, stress, and verbal intelligence. Next, participants will be randomly assigned to inhale vapor from cannabis containing 20mg THC, 40mg THC, or placebo; both cannabis and placebo will be obtained from the National Institute on Drug Abuse (NIDA). Participants will then will complete a battery of memory tests including tests of prospective, verbal, visuospatial, source, verbal working, visuospatial working, false, and temporal order memory. Memory tests will be completed across two blocks in a counterbalanced order. Saliva samples will be obtained two additional times after drug/placebo administration. Ratings of intoxication, mood, anxiety, and stress will be obtained three additional times after drug/placebo administration. The investigators hypothesize that participants who are randomly assigned to inhale cannabis vapor will perform worse on all memory tests than participants who inhale the placebo.
First Posted: August 4, 2022
Condition(s): Cannabis Use
Intervention(s): Cannabis, Placebo
Status: Recruiting
Enrollment (expected or actual): 156
Allocation: Randomized
Sponsor: Washington State University
Principal Investigator: Ryan Mclaughlin, Associate Professor
Completion Date (primary or actual): December 1, 2024
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