Systematically Testing the Evidence on Marijuana

This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.

First Posted: May 18, 2023

Condition(s): Pain, Abuse, Drug, Intoxication; Cannabinoids

Intervention(s): Cannabis, Dronabinol, Smoked Placebo, Oral Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 103

Allocation: Randomized

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor / Director

Completion Date (primary or actual): March 1, 2028

CT.gov Identifier: NCT05865470

CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.

First Posted: May 18, 2023

Condition(s): Cancer, Epilepsy, Neurodevelopmental Disorders

Intervention(s): Medical Cannabis

Status: Recruiting

Enrollment (expected or actual): 500

Allocation:

Sponsor: University of Manitoba

Principal Investigator:

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

CT.gov Identifier: NCT05863910

There has been a considerable rise in cannabis consumption in recent years, with estimates of 200 million individual users globally. Importantly, 3% of these individuals have cannabis use disorder (CUD), with this prevalence increasing to 33% amongst regular users, making it one of the most common substances use disorders (SUDs) worldwide. CUD is associated with substantial health, societal, and economic costs, and worsening of other psychiatric disorders. Despite this clinical burden, effective treatment options are limited. No pharmacological treatments have emerged as clearly efficacious, and psychotherapeutic interventions have shown tempered results. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of addictions. Evidence has indicated its efficacy in reducing drug craving and consumption across numerous SUDs, although research into cannabis has been largely unexplored. Recently, a novel circular rTMS coil, the MagVenture MMC-140, has been developed with the capacity to modulate both the bilateral prefrontal cortex (PFC) and insula, both of which are implicated in the neurocircuitry of craving and executive function. As such, it shows potential for CUD treatment. This proof-of-concept clinical trial will evaluate the feasibility and tolerability of a 4-week course of rTMS to the PFC/insula using MMC-140 as a treatment for CUD. Feasibility of both high frequency (HF; excitatory) and low frequency (LF; inhibitory) stimulation parameters will be evaluated. In addition, pre/post rTMS changes in cannabis use outcomes (e.g., consumption, craving, and withdrawal), executive function, and PFC/insula functional connectivity will be explored. By comprehensively investigating clinical, cognitive, and neuroimaging effects of rTMS, this study could pave the way for the first brain-based intervention in CUD that could be widely adopted into clinical settings using a novel, cost-effective and accessible rTMS device.

First Posted: May 16, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): Repetitive Transcranial Magnetic Stimulation

Status: Recruiting

Enrollment (expected or actual): 46

Allocation: Randomized

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): May 15, 2025

CT.gov Identifier: NCT05859347

The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.

First Posted: May 18, 2023

Condition(s): Tuberous Sclerosis Complex Associated Neuropsychiatric Disease

Intervention(s): Cannabidiol Oral Solution [Epidiolex]

Status: Recruiting

Enrollment (expected or actual): 75

Allocation: N/A

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

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

CT.gov Identifier: NCT05864846

Randomized clinical trial of 10 days Cannabidiol versus placebo as an adjunctive treatment during inpatient alcohol detoxification to improve abstinence in patients with severe alcohol use disorder.

First Posted: May 16, 2023

Condition(s): Severe Alcohol Use Disorder (DSM 5)

Intervention(s): Placebo, Half dose, Full dose

Status: Not yet recruiting

Enrollment (expected or actual): 210

Allocation: Randomized

Sponsor: Assistance Publique - Hôpitaux de Paris

Principal Investigator:

Completion Date (primary or actual): November 2023

CT.gov Identifier: NCT05860699

This study consists in the the design, implementation, and evaluation of the first web-based computer tailored intervention program aimed at the prevention of cannabis use in Spanish adolescents (ALERTA CANNABIS). A Cluster Randomized Controlled Trial is conducted to test the effectiveness of ALERTA CANNABIS in students aged 14 to 18 years across 34 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC).

First Posted: May 9, 2023

Condition(s): Cannabis Use, Adolescent Behavior, E-health

Intervention(s): ALERTA CANNABIS

Status: Recruiting

Enrollment (expected or actual): 1850

Allocation: Randomized

Sponsor: University of Seville

Principal Investigator: Marta Lima-Serrano, PhD, Associate Professor

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

CT.gov Identifier: NCT05849636

Although effective evidence-based interventions have been developed for alcohol and cannabis use disorders, it is still unclear which individuals respond best to treatment. A recent model known as the Addictions Neuroclinical Assessment (ANA) proposes that assessing for differences in three neurofunctional domains (executive function, incentive salience, and negative emotionality) could allow for a stronger neuroscience-based framework for understanding heterogeneity in response to addiction treatments but this has never been tested prospectively. In this study, we will recruit two groups: (1) participants with alcohol use disorder (AUD) and (2) participants with cannabis use disorder (CUD). Participants will undergo thorough baseline assessments of each of the three ANA domains prior to evidence-based treatment for their respective disorders. Individuals with AUD will be treated with 12 weeks of cognitive behavioral therapy (CBT) for AUD plus optional pharmacotherapy guided by a pharmacotherapy algorithm. Individuals with CUD will be treated with 12 weeks of CBT + motivational enhancement therapy for CUD. The primary objective of the study is to assess whether baseline ANA measures are associated with changes in drug consumption and craving over treatment.

First Posted: May 11, 2023

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

Intervention(s): CBT

Status: Recruiting

Enrollment (expected or actual): 400

Allocation: Non-Randomized

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): December 2027

CT.gov Identifier: NCT05855668

This observational study is being conducted to determine plasma concentrations of tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of subjects who visit the emergency department due to acute cannabinoid intoxication.

First Posted: August 30, 2023

Condition(s): Acute Cannabinoid Intoxication

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 120

Allocation:

Sponsor: Anebulo Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): June 30, 2024

CT.gov Identifier: NCT06017622

To collect information about how patients in the pain management clinic use cannabis/CBD, including how often it is used, why it is used (for example, to manage pain or other symptoms), and where patients get their information on cannabis/CBD for pain management

First Posted: May 1, 2023

Condition(s): Cancer

Intervention(s): Cannabis (Marijuana), Cannabidiol (CBD)

Status: Recruiting

Enrollment (expected or actual): 100

Allocation:

Sponsor: M.D. Anderson Cancer Center

Principal Investigator:

Completion Date (primary or actual): May 31, 2023

CT.gov Identifier: NCT05836857

The goal of this clinical trial is to investigate the (cost-)effectiveness of contingency management (CM) compared with Cognitive Behavioural Therapy (CBT) for the treatment of cannabis use disorder (CUD) in youth (16-22 years). The main questions it aims to answer are: What is the efficacy of 12 weeks outpatient CM versus CBT in youths with a CUD, in terms of cannabis abstinence during the intervention period? What is the long-term efficacy of CM versus CBT at 6- and 12-months follow-up (FU)? What is the cost-effectiveness of CM versus CBT at 12-months FU from a societal perspective? Study hypotheses are: 1. CM will result in more cannabis-abstinent days than CBT during the intervention; 2. CM is more effective and cost-effective than CBT at 12 months follow-up. Eligible patients (n=154) will be randomly assigned to either 12 weeks of outpatient CM or CBT. Assessments are conducted by trained research-assistants at baseline, after 6, 12, 26 and 52 weeks, and twice-weekly during treatment and consist of questionnaires, a computer task and collection of urine samples. Primary endpoint is the number of biochemically verified cannabis abstinent days in the 12-week treatment period. Key secondary endpoint: Treatment response: 50% or more reduction in cannabis use days in the past 4 weeks, compared with baseline. The primary outcome will be modelled in the intention-to-treat population in a (negative binomial) regression analysis with treatment group as independent variable and stratification variables as covariates. Cost-effectiveness and cost-utility analysis (CEA; CUA) will be performed from a societal perspective. CEA: Treatment response is the central clinical endpoint for calculations of incremental costs per responder. CUA: Incremental costs per QALY (based on EuroQoL).

First Posted: May 1, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): Abstinence-focused Contingency Management (CM) - stand alone, Standard Outpatient Cognitive Behavioural Therapy (CBT)

Status: Not yet recruiting

Enrollment (expected or actual): 154

Allocation: Randomized

Sponsor: Parnassia Addiction Research Centre

Principal Investigator:

Completion Date (primary or actual): January 2026

CT.gov Identifier: NCT05836207

The purpose of this study is to investigate the effects of cannabidiol (CBD) broad-spectrum oil on memory reconsolidation (memory storage) and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm.

First Posted: June 7, 2023

Condition(s): Posttraumatic Stress Disorder

Intervention(s): Trauma Memory Reactivation, Cannabidiol (CBD) Broad-Spectrum Oil, Placebo Oil

Status: Suspended

Enrollment (expected or actual): 120

Allocation: Randomized

Sponsor: University of Texas at Austin

Principal Investigator: Michael J. Telch, Professor of Clinical Psychology

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

CT.gov Identifier: NCT05892276

This research project proposes a novel approach to elucidate the biological adaptations associated with heavy cannabis use and to assess whether such adaptations are predictive of higher cannabis craving in response to both cannabis cues and stressors.

First Posted: April 27, 2023

Condition(s): Cannabis Use, Cannabis, Cannabis Abuse

Intervention(s): Intensive Day Monitoring

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: N/A

Sponsor: Yale University

Principal Investigator:

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

CT.gov Identifier: NCT05833230

This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as cannabis. This study will help researchers learn about ways of delivering this information that is both appealing and helpful to young adults who use mobile apps.

First Posted: April 24, 2023

Condition(s): Cannabis Use

Intervention(s): Just-In-Time-Adaptive-Intervention (JITAI)

Status: Not yet recruiting

Enrollment (expected or actual): 120

Allocation: N/A

Sponsor: University of Michigan

Principal Investigator: Inbal Billie Nahum-Shani, Associate Professor

Completion Date (primary or actual): December 2024

CT.gov Identifier: NCT05824754

This study seeks to understand how cannabidiol (CBD) - a non-intoxicating chemical compound obtained from the Cannabis sativa plant - affects biological and stress-related responses that are believed to underlie anxiety disorders. This study will evaluate the effects of different doses of CBD on blood plasma levels of anandamide (a molecule in the brain that has been shown to help regulate stress responses; primary biological signature) and anxiety reactivity to a standardized stress task (secondary target) in an acute (4-day) dosing study (i.e., when steady state CBD levels have been reached). Approximately 60 subjects with social anxiety disorder (SAD), ages 18-70, will participate in this study. They will be assigned by chance to receive one of two doses of CBD (150 mg BID or 450 mg BID administered in two divided doses daily) or placebo (which resembles the study drug but has no active ingredients) BID for 3 days and on the morning of day 4. Knowledge gained from this study will help determine the therapeutic potential of CBD for anxiety.

First Posted: April 21, 2023

Condition(s): Social Anxiety, Social Anxiety Disorder

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Charles Taylor, Associate Professor

Completion Date (primary or actual): April 2025

CT.gov Identifier: NCT05823753

The purpose of this study is to identify the effect dronabinol has on opioid exposure when used as an adjunct to the current standard multi-modal pain regimen (MMPR)

First Posted: April 20, 2023

Condition(s): Trauma Injury

Intervention(s): Standard of care, Dronabinol

Status: Not yet recruiting

Enrollment (expected or actual): 664

Allocation: Randomized

Sponsor: The University of Texas Health Science Center, Houston

Principal Investigator: John Andrew Harvin, Associate Professor

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

CT.gov Identifier: NCT05820685

Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic agent, and is most supported by the scientific community as an antiepileptic. Additionally, CBD is also associated with claims related to improvements in overall health, pain, anxiety, depression, and sleep; however, the scientific evidence is lacking. The overarching goal of this investigation is to determine the effects of a 4-week CBD intervention on measures of overall health, pain, anxiety, depression, and sleep in a population of US veterans. Primary aims will explore the effects of 4 weeks of CBD on pain, anxiety, and depression. Secondary aims will determine whether 4 weeks of CBD will affect general measures of overall health and sleep.

First Posted: May 9, 2023

Condition(s): Healthy

Intervention(s): Vantage Hemp CBD, Vantage Hemp Placebo Capsule

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of Northern Colorado

Principal Investigator: Laura Stewart, Professor

Completion Date (primary or actual): December 31, 2023

CT.gov Identifier: NCT05850754

This is a double-blind, randomized controlled trial designed to test the effects of cannabidiol (CBD) on validated biomarkers of Alzheimer's disease (AD) progression, behavioral and clinical measures, with putative mechanisms of CBD action.

First Posted: April 20, 2023

Condition(s): Mild Cognitive Impairment

Intervention(s): Cannabidiol, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 236

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): April 2028

CT.gov Identifier: NCT05822362

This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.

First Posted: April 18, 2023

Condition(s): Insomnia

Intervention(s): Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM), Sleep Hygiene Education (SHE-TM)

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: Randomized

Sponsor: University of Michigan

Principal Investigator: J. Todd Arnedt, Professor of Psychiatry, Professor of Neurology

Completion Date (primary or actual): August 2027

CT.gov Identifier: NCT05814822

This is a pilot, open-label, phase II study. The main objective of the study is to demonstrate that Cannabidiol (CBD), used in addition to current anti-seizure medications (ASMs) reduces the number and/or severity of motor (generalized, focal, or both) seizures in children and young adults with rare disease-associated severe epilepsy. Secondary objectives include assessment of safety and tolerability, changes in behaviour, cognition and sleep, pharmacokinetic interaction with concurrent ASMs.

First Posted: April 7, 2023

Condition(s): Epilepsy, Rare Diseases

Intervention(s): Cannabidiol oral solution

Status: Not yet recruiting

Enrollment (expected or actual): 30

Allocation: N/A

Sponsor: Meyer Children's Hospital IRCCS

Principal Investigator: Renzo Guerrini, Director, Head of Child Neurology Department, Principal Investigator, Clinical Professor

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

CT.gov Identifier: NCT05803434

This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.

First Posted: March 27, 2023

Condition(s): Schizophrenia, Cannabis Use Disorder

Intervention(s): tDCS

Status: Recruiting

Enrollment (expected or actual): 138

Allocation: Randomized

Sponsor: Centre hospitalier de Ville-Evrard, France

Principal Investigator: Noomane Bouaziz, MD, Principal Investigator

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

CT.gov Identifier: NCT05784961

The primary objective of this study is to evaluate an Integrative Therapy for Adolescent Cannabis Use (TIMCA), integrating elements of Motivational Interviewing (MI), Cognitive Behavioral Therapies (CBT) and an Attachment-Based Intervention (ABI), (IBA),compared to Treatment As Usual (TAU) on cannabis use. The secondary objectives of the study are: To assess the effectiveness of the TIMCA, in comparison to the TAU, on: (1) Relationship quality with parents, (2) Relationship quality with closest friend, (3) Emotional regulation strategies, (4) Depressive symptomatology, (5) Anxiety symptomatology, (6) Adherence to therapy

First Posted: March 13, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): TIMCA, Treatment as Usual

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Centre Hospitalier St Anne

Principal Investigator:

Completion Date (primary or actual): June 9, 2025

CT.gov Identifier: NCT05765409

Glioblastoma (GBM) is the most common malignant brain tumor among adults. As the diagnosis is generally considered terminal, patients with GBM often suffer from anxiety and other comorbid conditions, including depression, pain, and sleep disturbance, all of which significantly impact their quality of life. Previous studies have demonstrated the potential of cannabinoids, particularly cannabidiol (CBD), to improve the aforementioned symptoms without conferring significant risks or side effects. Further, recent in-vitro and in-vivo work suggests potential cytotoxic and anti-tumor effects of CBD and other cannabinoids. This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product on measures of anxiety, pain, and quality of life in newly-diagnosed GBM patients undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor progression will also be assessed. The proposed clinical trial will provide important information that does not currently exist regarding the potential efficacy of a novel full-spectrum, ultra-high CBD product to address clinical symptoms in patients with GBM.

First Posted: March 3, 2023

Condition(s): Glioblastoma

Intervention(s): Cannabidiol (CBD), Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 36

Allocation: Randomized

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): September 2025

CT.gov Identifier: NCT05753007

POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.

First Posted: February 24, 2023

Condition(s): Cannabis, Chronic Kidney Diseases, Dialysis

Intervention(s): Tetrahydrocannabinol-Cannabidiol Combination

Status: Recruiting

Enrollment (expected or actual): 24

Allocation: N/A

Sponsor: McMaster University

Principal Investigator:

Completion Date (primary or actual): December 31, 2023

CT.gov Identifier: NCT05742724

The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.

First Posted: February 24, 2023

Condition(s): Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant, Primary Progressive Aphasia, bvFTD, PPA, FTD

Intervention(s): Nabilone, Placebo

Status: Active, not recruiting

Enrollment (expected or actual): 45

Allocation: Randomized

Sponsor: Simon Ducharme, MD

Principal Investigator: Simon Ducharme, MD, Associate Professor, McGill University

Completion Date (primary or actual): May 2025

CT.gov Identifier: NCT05742698

This study tests of effect of brief education and support about tobacco, e-cigarette, and cannabis waste (TECW) on knowledge, beliefs, behavior, and TECW on two college campuses.

First Posted: March 2, 2023

Condition(s): Knowledge, Attitudes, Practice

Intervention(s): Education plus Support

Status: Active, not recruiting

Enrollment (expected or actual): 400

Allocation: Randomized

Sponsor: California State University, San Marcos

Principal Investigator:

Completion Date (primary or actual): December 13, 2024

CT.gov Identifier: NCT05751369