Recruiting
Phase 2

Cannabidiol

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06512389

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Oral solution

Study Details

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

Study ID

NCT06512389

Start date

Aug 16, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cannabidiol

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

placebo comparator: Placebo

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

Interventions

Oral solution

300 mg taken morning and evening

Primary outcome measure

  • Total number of drinks administered during the alcohol-self administration session [ Time Frame: 2 hours ]
  • Peak breath alcohol concentration during the alcohol-self administration session [ Time Frame: 2 hours ]
  • Craving at baseline as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session. [ Time Frame: Baseline ]
  • Craving following the priming dose of alcohol as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session. [ Time Frame: 20 min after priming dose ]

Central Contacts and Locations

Central contacts

Kelly Xiao, MSc

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

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Kelly Xiao, MSc

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

Principal Investigator:

Matthew E Sloan, MD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • alcohol use disorder
  • cannabidiol
  • alcohol consumption
  • craving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-03-20.