Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

NCT06512389 | Recruiting Phase 2

• 1 other identifier: 2021/102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This human laboratory study aims to assess the effects of cannabidiol on alcohol consumption and craving in participants with alcohol use disorder. In this double-blind within-subject placebo-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorder; cannabidiol; alcohol consumption; craving

Outcome Measures

Primary Outcomes (4)

• Total number of drinks administered during the alcohol-self administration session

  Number of drinks consumed during the alcohol self-administration session.

  2 hours

• Peak breath alcohol concentration during the alcohol-self administration session

  Maximum breath alcohol concentration during the alcohol self-administration session.

  2 hours

• Craving at baseline as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.

  Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving)

  Baseline

• Craving following the priming dose of alcohol as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.

  Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving)

  20 min after priming dose

Secondary Outcomes (6)

• Subjective effects of alcohol during the alcohol self-administration session as measured by the Drug Effects Questionnaire.

  3 hours

• Subjective effects of alcohol during the alcohol self-administration session as measured by the Brief Biphasic Alcohol Effects Scale

  3 hours

• Safety and tolerability of CBD

  Approximately 5 weeks

• Differences in alcohol consumption (measured by the Timeline Follow Back method) outside of the lab during treatment with CBD vs. placebo

  10 days

• Differences in alcohol craving (measured by Penn Alcohol Craving Scale) outside of the lab during treatment with CBD vs. placebo

  7 days

Study Arms (2)

Cannabidiol

EXPERIMENTAL

10-day supply of 600 mg of CBD, taken orally twice daily

Drug: Oral solution

Placebo

PLACEBO COMPARATOR

10-day supply of 600 mg of placebo, taken orally twice daily

Drug: Oral solution

Interventions

Oral solution DRUG

300 mg taken morning and evening

Cannabidiol; Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-5 criteria for AUD.
• Meets drinking criteria of average weekly consumption \> 10 standard drinks for women and \> 15 standard drinks for men over the past 90 days.
• Willing to take study medication and participate in laboratory sessions requiring self-administration of alcohol
• Agrees not to use cannabis or illicit drugs during the study period.
• Able to communicate and provide informed consent in English.
• Alanine Aminotransferase (ALT) and Aspartate Transaminase (AST) level should not be more than 2 times the upper normal limit, and bilirubin should not be more than 1.5 times the upper normal limit.
• Enrolled in the Ontario Health Insurance Plan (OHIP)
• Willing and able to safely abstain from alcohol for at least 12 hours prior to the eligibility and alcohol self-administration visit.
• Individuals who are capable of becoming pregnant: agree to the use of highly effective contraception during study participation and for an additional 28 days after the end of cannabidiol administration.

You may not qualify if:

• Clinical Institute Withdrawal Assessment (CIWA-Ar) score of 10 or above upon initial assessment
• History of severe alcohol withdrawal including withdrawal seizures, alcoholic hallucinosis, or delirium tremens
• Any history of seizures
• Serious unstable medical condition, including severe hepatic abnormalities
• Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study
• Current medical conditions, prescriptions, or over the counter medications that interfere with receiving the study drug or alcohol (based on the study physician's assessment)
• Severe mental illness (e.g. active psychosis with ongoing delusions and/or hallucinations, active manic or hypomanic episodes, evidence of a major neurocognitive disorder, etc.) and other substance use disorders (moderate or severe; excluding tobacco use disorder) as determined by the qualified investigator
• Experiencing active suicidal ideation within the past 1 month and/or suicide attempt within the past 6 months
• Recent recreational drug use (assessed via urine toxicology screen) other than alcohol and nicotine products
• Current use of CBD products or use of CBD products within the past month.
• History of hypersensitivity to CBD
• Self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency)
• Currently pregnant or breastfeeding or intending to become pregnant or breastfeed.
• Currently institutionalized which refers to a person who lives in an institutional collective dwelling, such as a hospital, nursing home or prison, including a resident under custody (e.g., patient or inmate).
• Currently in treatment for AUD (e.g. Alcoholics Anonymous, group therapy, individual therapy, on anticraving medication)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

Solutions

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Matthew Sloan, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Xiao, MSc

CONTACT

416-535-8501; kelly.xiao@camh.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject randomized double-blind placebo controlled crossover trial

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: August 16, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CA (1)