Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT06512389

Run by

Centre for Addiction and Mental Health

People needed

36

Starts

2024-08-16

Expected to finish

2026-06-30

Last updated by the study team

2026-03-20

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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