Systematically Testing the Evidence on Marijuana

This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with HIV (PLWH) receiving combination anti-retroviral therapy (cART) (80 regular cannabis users and 80 non-users) and HIV uninfected (HIV-) controls (80 regular cannabis users and 80 non-users). This study will provide key insights into the effects of regular cannabis and HIV on peripheral and brain markers of immune function and NP in PLWH and HIV- controls. These insights are critical for cure strategies and ongoing HIV treatment initiatives.

First Posted: June 24, 2022

Condition(s): HIV Infections, Cannabis

Intervention(s): MRI, NeuroPsychological Testing, Blood Draw, Questionnaires, Lumbar Puncture

Status: Enrolling by invitation

Enrollment (expected or actual): 320

Allocation:

Sponsor: Washington University School of Medicine

Principal Investigator:

Completion Date (primary or actual): June 30, 2025

CT.gov Identifier: NCT05430490

This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.

First Posted: June 27, 2022

Condition(s): Cannabis Use

Intervention(s): Placebo, THC, Beta-Myrcene

Status: Not yet recruiting

Enrollment (expected or actual): 32

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): November 2025

CT.gov Identifier: NCT05432284

Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.

First Posted: July 6, 2022

Condition(s): Psychotic Disorders, Cannabis Use Disorder, Cannabis Dependence, Cannabis Use, Schizophrenia; Psychosis, Cognitive Dysfunction, Memory Impairment, Neuroimaging

Intervention(s): Contingency management

Status: Recruiting

Enrollment (expected or actual): 134

Allocation: Randomized

Sponsor: Douglas Mental Health University Institute

Principal Investigator: Rachel Rabin, Assistant Professor

Completion Date (primary or actual): May 2027

CT.gov Identifier: NCT05445180

This pilot crossover study will evaluate 3 different potencies of inhaled cannabis (2.5%, 5%, and 10%) and inhaled placebo cannabis for the acute treatment of migraine.

First Posted: June 22, 2022

Condition(s): Migraine, Cannabis, THC

Intervention(s): THC ~2.5%, THC ~5%, THC ~10%, Sham Cannabis

Status: Not yet recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Nathaniel Schuster, Associate Professor

Completion Date (primary or actual): October 1, 2024

CT.gov Identifier: NCT05427630

The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using [11C]UCB-J PET imaging.

First Posted: July 19, 2022

Condition(s): Cannabis Use

Intervention(s): [11C]UCB-J PET

Status: Recruiting

Enrollment (expected or actual): 24

Allocation: Non-Randomized

Sponsor: Yale University

Principal Investigator: Rajiv Radhakrishnan, Principal Investigator

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

CT.gov Identifier: NCT05465538

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: June 9, 2022

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): September 1, 2022

CT.gov Identifier: NCT05413187

The purposes of this study are 1) to determine if the administration of different low doses of oral CBD (20 mg, 50 mg, 100 mg and 200 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose of oral CBD is associated with effects that are not detected with the available research tools.

First Posted: June 7, 2022

Condition(s): Cannabis

Intervention(s): Cannabis, placebo

Status: Not yet recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

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

Principal Investigator:

Completion Date (primary or actual): July 2023

CT.gov Identifier: NCT05407285

The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral therapy approaches for this population. Consequently, there is a pressing need for the development of new treatments, including approaches that specifically target the brain areas associated with problematic cannabis use behaviors. Elevated attention to drug cues is one of the primary causes of relapse in heavy cannabis users. Preliminary data suggests that transcranial magnetic stimulation (TMS), a non-invasive form of brain stimulation, may be a novel brain-based tool to decrease heightened attention to drug cues in people with CUD. Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and reduce cannabis use. This study will evaluate whether 2 weeks of rTMS can be used to decrease attentional bias to cannabis cues and reduce cannabis use in heavy cannabis users. We will recruit sixty (60) non-treatment seeking, near-daily cannabis users to receive 10 daily sessions of either real or sham (aka placebo) rTMS over a 2-week period. Participants will live on a residential research unit for 3 weeks. During the residential stay, data on cannabis use (measured using standard human laboratory measures of choice to smoke cannabis) and relevant brain activity (measured using drug cue exposure fMRI tasks) will be collected before and after the course of 10 daily rTMS sessions. We will aim to show whether real rTMS treatment reduces brain response and attentional bias to cannabis cues and reduces cannabis use levels.

First Posted: June 2, 2022

Condition(s): Cannabis

Intervention(s): iTBS, iTBS

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: New York State Psychiatric Institute

Principal Investigator: Tonisha Kearney-Ramos, Research Scientist III/Assistant Professor of Clinical Neurobiology (in Psychiatry)

Completion Date (primary or actual): July 2027

CT.gov Identifier: NCT05401929

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: May 25, 2022

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

Intervention(s): THC-dominant cannabis, CBD-dominant cannabis, Cannabis placebo, Alcohol, Alcohol placebo

Status: Not yet recruiting

Enrollment (expected or actual): 350

Allocation: Randomized

Sponsor: Brown University

Principal Investigator:

Completion Date (primary or actual): March 2027

CT.gov Identifier: NCT05389930

The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder

First Posted: May 24, 2022

Condition(s): Alcohol Use Disorder (AUD)

Intervention(s): Cannabidiol (CBD), Placebo

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: South West Sydney Local Health District

Principal Investigator: Kirsten Morley BPsych MPH PhD, Associate Professor Kirsten Morley

Completion Date (primary or actual): June 2023

CT.gov Identifier: NCT05387148

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: May 24, 2022

Condition(s): Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm

Intervention(s): Cannabidiol, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Mayo Clinic

Principal Investigator:

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

CT.gov Identifier: NCT05388058

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: How did participants use the Guide? (Eg: daily; read once; 'a la carte') How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)? Did using the Guide yield any benefits beyond tolerance break fidelity? (Eg: insight into patterns of use)

First Posted: May 19, 2022

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): July 1, 2021

CT.gov Identifier: NCT05382273

Alternative and complementary medicines (MAC) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. In consistence with guidelines from the French Society for Oncology Pharmacy (SFPO), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. This aim to prevent and manage herb-drug interaction as well as other drug-related problems (DRP). The recent French experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of MAC. However, cannabidiol have shown inhibitory effect on different cytochromes with a risk of HDI as other MAC. While the prevalence of MAC consumption is already known in some type of cancer, the consumption of CBD is less known and should be explored. Through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. We also want to validate a questionnaire through a literacy scale.

First Posted: June 7, 2022

Condition(s): Cancer

Intervention(s): Non applicable

Status: Completed

Enrollment (expected or actual): 350

Allocation:

Sponsor: CHU de Reims

Principal Investigator:

Completion Date (primary or actual): December 31, 2021

CT.gov Identifier: NCT05407298

This study is looking at therapeutic potential of reducing Tetrahydrocannabinol (THC) levels in regular cannabis smokers using contingency management (CM) intervention in a U.S. veteran population with post-traumatic stress disorder (PTSD).

First Posted: May 23, 2022

Condition(s): Post Traumatic Stress Disorder, Cannabis Use, Suicide

Intervention(s): Reduce THC Use

Status: Recruiting

Enrollment (expected or actual): 215

Allocation: Non-Randomized

Sponsor: Wayne State University

Principal Investigator: Leslie Lundahl, Associate Professor

Completion Date (primary or actual): December 31, 2026

CT.gov Identifier: NCT05386862

Veterans with diabetes are more likely than diabetic civilians to develop disabling chronic diabetic neuropathic pain (CDNP). Research on frontline treatments for CDNP (enhanced glycemic control, exercise, pharmacological agents), shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CDNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CDNP is vital. The present phase II study will offer the first evidence describing the potential benefits and adverse effects of cannabinoids for CDNP in Veterans using a four-arm, double-blind, multisite randomized trial comparing THC, CBD, THC+CBD and placebo on neuropathic pain outcomes.

First Posted: April 28, 2022

Condition(s): Diabetic Neuropathic Pain

Intervention(s): THC (Dronabinol), CBD (Epidolex), THC + CBD (Nabiximols), Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 320

Allocation: Randomized

Sponsor: VA Office of Research and Development

Principal Investigator:

Completion Date (primary or actual): June 30, 2027

CT.gov Identifier: NCT05351801

The objective of this randomized, placebo-controlled and crossover study is to extend the findings from the acute studies into more chronic administration of CBD in individuals with mild or moderate hypertension who are either untreated or receiving standard care therapy. The hypothesis is that the hypotensive effects of CBD will be apparent in both untreated and treated hypertension and reflected in improved vascular biomarkers and psychological well-being.

First Posted: April 26, 2022

Condition(s): Hypertension

Intervention(s): Cannabidiol, Placebo

Status: Active, not recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: University of Split, School of Medicine

Principal Investigator: Zeljko Dujic, Professor

Completion Date (primary or actual): October 5, 2022

CT.gov Identifier: NCT05346562

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: April 26, 2022

Condition(s): Underage Drinking, Cannabis Use, Drinking, Teen, Drinking, College, College Drinking, Teen Drinking

Intervention(s): e-PBI+, e-PBI

Status: Not yet recruiting

Enrollment (expected or actual): 2425

Allocation: Randomized

Sponsor: Penn State University

Principal Investigator: Robert Turrisi, Professor of Biobehavioral Health

Completion Date (primary or actual): July 2026

CT.gov Identifier: NCT05345951

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: April 20, 2022

Condition(s): Chronic Migraine

Intervention(s): LGP1:20

Status: Not yet recruiting

Enrollment (expected or actual): 20

Allocation: N/A

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): December 31, 2024

CT.gov Identifier: NCT05337033

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: April 19, 2022

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: Recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Northwestern University

Principal Investigator: Vehniah Tjong, Assistant Professor

Completion Date (primary or actual): February 2023

CT.gov Identifier: NCT05335252

The CanCope Study is a micro-randomized trial conducted to gather evidence about and compare the effectiveness of a momentary intervention to help young adults cope with cannabis cravings as they attempt to reduce their use.

First Posted: April 14, 2022

Condition(s): Cannabis Use

Intervention(s): CanCope

Status: Completed

Enrollment (expected or actual): 55

Allocation: Randomized

Sponsor: Trustees of Dartmouth College

Principal Investigator:

Completion Date (primary or actual): December 16, 2021

CT.gov Identifier: NCT05328362

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. The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This study will provide additional data on the efficacy of AEF0117 on treatment-seeking subjects with moderate to severe CUD. This is a phase 2b, randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study. The overall purpose of this study is to assess the efficacy and safety of AEF0117 in subjects with moderate to severe CUD who are treatment-seeking. The primary objective of this study is to demonstrate that AEF0117 induces a greater proportion of RESPONDERS (i.e., subjects with a RESPONSE of ≤1 day of cannabis use per week) compared to placebo in treatment-seeking subjects with moderate to severe CUD, according to DSM-5 criteria.The secondary objectives are to investigate the proportion of subjects that reach various levels of reduction and how this influences their quality of life, and to evaluate the safety and tolerability of AEF0117. And the exploratory objectives of this study are to further evaluate the effect of AEF0117 on pattern of cannabis use and change in various signs and symptoms, and in addition to assess effects during the grace period and the entire treatment period.

First Posted: April 12, 2022

Condition(s): Marijuana Abuse

Intervention(s): AEF0117, Placebo oral capsule

Status: Recruiting

Enrollment (expected or actual): 330

Allocation: Randomized

Sponsor: Aelis Farma

Principal Investigator:

Completion Date (primary or actual): August 2023

CT.gov Identifier: NCT05322941

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

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): June 2025

CT.gov Identifier: NCT05396638