Systematically Testing the Evidence on Marijuana

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): January 30, 2023

CT.gov Identifier: NCT05562635

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: Recruiting

Enrollment (expected or actual): 225

Allocation: Randomized

Sponsor: PleoPharma, Inc.

Principal Investigator:

Completion Date (primary or actual): September 2023

CT.gov Identifier: NCT05494437

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

CT.gov Identifier: NCT05498012

This study will examine the acute effects of cannabis on various aspects of memory. Eligible participants will complete a drug screen followed by baseline measures of cannabis consumption patterns, level of intoxication, euphoria, anxiety, stress, and verbal intelligence. Next, participants will be randomly assigned to inhale vapor from cannabis containing 20mg THC or placebo; both cannabis and placebo will be obtained from the National Institute on Drug Abuse (NIDA). Participants will complete a battery of memory tests including tests of prospective, verbal, visuospatial, autobiographical, source, verbal working, visuospatial working, false, and temporal order memory. Memory tests will be completed across two blocks in a counterbalanced order. Ratings of intoxication, euphoria, 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: Not yet recruiting

Enrollment (expected or actual): 128

Allocation: Randomized

Sponsor: Washington State University

Principal Investigator:

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

CT.gov Identifier: NCT05488509

The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.

First Posted: August 2, 2022

Condition(s): Marijuana Use, Opioid Use

Intervention(s): Marijuana, Opioid

Status: Not yet recruiting

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: Shanna Babalonis, PhD

Principal Investigator: Shanna Babalonis, PhD, Assistant Professor

Completion Date (primary or actual): August 2024

CT.gov Identifier: NCT05485012

The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.

First Posted: August 5, 2022

Condition(s): CBD, Transplant Complication, Kidney Disease, Chronic

Intervention(s): Tacrolimus single dose, Epidiolex single dose, Epidiolex steady-state and tacrolimus single dose

Status: Recruiting

Enrollment (expected or actual): 72

Allocation: Non-Randomized

Sponsor: Indiana University

Principal Investigator: Michael Eadon, Associate Professor of Medicine

Completion Date (primary or actual): September 2027

CT.gov Identifier: NCT05490511

The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. Youth will be recruited from the Center for Drug and Alcohol Programs (CDAP) Clinic in the Department of Psychiatry at MUSC. Follow-up assessments will be conducted at one- and three-months following treatment.

First Posted: August 3, 2022

Condition(s): Cannabis Use, Alcohol Use, Unspecified, Substance Use, Substance Use Disorders

Intervention(s): modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias, modified Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.

Status: Recruiting

Enrollment (expected or actual): 52

Allocation: Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: Austin Hahn, Assistant Professor

Completion Date (primary or actual): August 2025

CT.gov Identifier: NCT05486234

The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal [11C]APP-311/[11C]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal [11C]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.

First Posted: July 25, 2022

Condition(s): Cannabis Use Disorder, Healthy

Intervention(s): [11C]APP311

Status: Recruiting

Enrollment (expected or actual): 42

Allocation: Non-Randomized

Sponsor: Yale University

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

Completion Date (primary or actual): May 2027

CT.gov Identifier: NCT05472818

Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.

First Posted: July 14, 2022

Condition(s): Bipolar Disorder

Intervention(s): Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 25

Allocation: N/A

Sponsor: Mclean Hospital

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

Completion Date (primary or actual): July 2025

CT.gov Identifier: NCT05457465

Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.

First Posted: July 13, 2022

Condition(s): Effect of Drug

Intervention(s): Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 48

Allocation: Randomized

Sponsor: Penn State University

Principal Investigator: Lacy Alexander, Professor of Kinesiology

Completion Date (primary or actual): August 31, 2022

CT.gov Identifier: NCT05456113

To elucidate mechanisms of substance use disorders (SUD) and comorbid mental illnesses in people living with HIV (PLWH), the investigators propose to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. The study will take place in our health system in The Bronx-a persistent epicenter of the HIV epidemic due to profound poverty and health disparities. The focus is on young adults (ages 18-34) to minimize HIV chronicity effects and due to the high rates of SUD and reduced adherence to HIV treatments in this age group; among >31,000 diagnosed young PLWH in The Bronx in 2019, less than 70% had suppressed (<200 copies/mL) viral load (VL).

First Posted: July 12, 2022

Condition(s): Hiv, Depression, Cannabis Use Disorder

Intervention(s): MRI study - everyone scanned.

Status: Recruiting

Enrollment (expected or actual): 280

Allocation: N/A

Sponsor: Albert Einstein College of Medicine

Principal Investigator: Vilma Gabbay, PRIME Director

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

CT.gov Identifier: NCT05453513

Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.

First Posted: July 6, 2022

Condition(s): Tobacco Use, Tobacco Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation

Intervention(s): 300 mg Cannabidiol, 600 mg Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

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

CT.gov Identifier: NCT05445804

The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).

First Posted: June 29, 2022

Condition(s): Gastric Emptying, Cannabis

Intervention(s):

Status: Not yet recruiting

Enrollment (expected or actual): 108

Allocation:

Sponsor: The Guthrie Clinic

Principal Investigator:

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

CT.gov Identifier: NCT05436236

The behavioral and psychological symptoms of dementia affect up to 80% of long-term facilities residents with severe dementia. They seriously alter the quality of life of patients, relatives, and health professionals. Management involves correcting somatic and psychiatric factors and implementing non-drug interventions. Nevertheless, often drug treatments must be introduced with the limitations related to their effectiveness and adverse effects. The investigators hypothesize that medical cannabinoids will improve neuropsychiatric and behavioral symptoms of patients with severe dementia. The investigators assessed the feasibility and safety of administering a cannabis oil that contains tetrahydrocannabinol (THC) and Cannabidiol (CBD) during an initial study of about two years, observing an overall improvement, excellent tolerance to the treatment, and the possibility of reducing or even stopping other drugs. This research project aims to study the efficacy of medical cannabis oil in improving the quality of life of dementia patients experimenting with behavioral and psychological symptoms.

First Posted: June 27, 2022

Condition(s): Dementia With Behavioral Disturbance

Intervention(s): Cannabis Sativa Oil, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 24

Allocation: Randomized

Sponsor: Fondation pour l'accueil et l'hébérement des personnes âgées

Principal Investigator:

Completion Date (primary or actual): June 2024

CT.gov Identifier: NCT05432206

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 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: Enrolling by invitation

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Nathaniel Schuster, Associate Professor

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

CT.gov Identifier: NCT05427630

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

Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.

First Posted: July 28, 2022

Condition(s): Photorefractive Keratectomy, Myopia, Hyperopia

Intervention(s): oral cannabinoid, oral codeine/acetaminophen

Status: Not yet recruiting

Enrollment (expected or actual): 35

Allocation: Randomized

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): March 2025

CT.gov Identifier: NCT05477875

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

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 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

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

First Posted: March 13, 2023

Condition(s): Diabetic Peripheral Neuropathic Pain

Intervention(s): CBD/PEA, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 52

Allocation: Randomized

Sponsor: Pure Green Pharmaceuticals Inc.

Principal Investigator:

Completion Date (primary or actual): December 5, 2023

CT.gov Identifier: NCT05766969

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 0 mg, placebo, Cannabis 20 mg,, Cannabis 50 mg, Cannabis 100 mg, Cannabis 200 mg

Status: 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: Recruiting

Enrollment (expected or actual): 350

Allocation: Randomized

Sponsor: Brown University

Principal Investigator:

Completion Date (primary or actual): March 31, 2027

CT.gov Identifier: NCT05389930