Systematically Testing the Evidence on Marijuana

A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).

First Posted: October 31, 2022

Condition(s): Social Anxiety Disorder

Intervention(s): Cannabidiol oral solution, Cannabidiol oral solution, Placebo

Status: Recruiting

Enrollment (expected or actual): 225

Allocation: Randomized

Sponsor: EmpowerPharm Inc.

Principal Investigator:

Completion Date (primary or actual): September 2023

CT.gov Identifier: NCT05600114

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 four weeks of supplementation with 60 mg/day CBD affects energy intake at a single meal, and or fasting blood-based markers of appetite regulation and metabolic health. Healthy, adult volunteers will be assigned to placebo or CBD supplementation, in a randomized controlled trial, comparing changes in outcomes across the supplementation period between groups.

First Posted: March 17, 2023

Condition(s): Appetitive Behavior, Adverse Effect, Metabolic Health

Intervention(s): Cannabidiol (CBD) supplementation, Placebo supplementation

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Loughborough University

Principal Investigator: Lewis James, Senior Lecturer in Nutrition

Completion Date (primary or actual): October 1, 2023

CT.gov Identifier: NCT05774574

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: December 8, 2022

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): February 1, 2024

CT.gov Identifier: NCT05641766

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

CT.gov Identifier: NCT05581368

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

CT.gov Identifier: NCT05578313

ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Sativex with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).

First Posted: November 29, 2022

Condition(s): Glioblastoma, Brain Tumor, Cannabis, Brain Tumor, Recurrent

Intervention(s): Sativex, Temozolomide, Sativex-matched placebo

Status: Recruiting

Enrollment (expected or actual): 234

Allocation: Randomized

Sponsor: University of Birmingham

Principal Investigator:

Completion Date (primary or actual): February 2026

CT.gov Identifier: NCT05629702

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): May 30, 2024

CT.gov Identifier: NCT05571592

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: Not yet recruiting

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

CT.gov Identifier: NCT05563948

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

CT.gov Identifier: NCT05554146

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

CT.gov Identifier: NCT05632627

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

CT.gov Identifier: NCT05754840

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

CT.gov Identifier: NCT05672342

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: Not yet recruiting

Enrollment (expected or actual): 50

Allocation: N/A

Sponsor: University of Houston

Principal Investigator: Lorra Garey, Principal Investigator

Completion Date (primary or actual): August 23, 2023

CT.gov Identifier: NCT05566730

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

CT.gov Identifier: NCT05615389

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: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Loughborough University

Principal Investigator: Lewis James, Senior Lecturer in Nutrition

Completion Date (primary or actual): April 30, 2023

CT.gov Identifier: NCT05618756

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

CT.gov Identifier: NCT05526196

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

CT.gov Identifier: NCT05528380

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: Not yet recruiting

Enrollment (expected or actual): 370

Allocation: Randomized

Sponsor: Health Department of the Canton of Basel-Stadt

Principal Investigator: Marc Walter, Prof. Dr. med.

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

CT.gov Identifier: NCT05522205

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): September 14, 2023

CT.gov Identifier: NCT05521321

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): September 2025

CT.gov Identifier: NCT05519111

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

CT.gov Identifier: NCT05520294

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: Not yet 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

CT.gov Identifier: NCT05514899

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

CT.gov Identifier: NCT05516407

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

CT.gov Identifier: NCT05503147

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 2022

CT.gov Identifier: NCT05512091