Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT06512389

Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

Led by Centre for Addiction and Mental Health · Updated on 2026-03-20

36

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meets DSM-5 criteria for alcohol use disorder
  • Average weekly alcohol consumption over past 90 days is more than 10 standard drinks for women or more than 15 for men
  • Willing to take study medication and participate in alcohol self-administration sessions
  • Agree not to use cannabis or illicit drugs during the study
  • Able to communicate and give informed consent in English
  • Alanine Aminotransferase (ALT) and Aspartate Transaminase (AST) levels no more than 2 times the upper normal limit; bilirubin no more than 1.5 times the upper normal limit
  • Enrolled in the Ontario Health Insurance Plan (OHIP)
  • Willing and able to abstain from alcohol for at least 12 hours before eligibility and alcohol self-administration visits
  • Women capable of becoming pregnant agree to use highly effective contraception during the study and for 28 days after cannabidiol administration
Not Eligible

You will not qualify if you...

  • Clinical Institute Withdrawal Assessment (CIWA-Ar) score of 10 or above at initial assessment
  • History of severe alcohol withdrawal symptoms such as seizures, hallucinosis, or delirium tremens
  • Any history of seizures
  • Serious unstable medical conditions including severe liver abnormalities
  • Conditions, drug sensitivities, or prior therapies making participation unsuitable as judged by investigator
  • Current medical conditions or medications interfering with study drug or alcohol use as assessed by study physician
  • Severe mental illness or other moderate/severe substance use disorders (except tobacco)
  • Active suicidal thoughts in past month or suicide attempt in past 6 months
  • Recent recreational drug use other than alcohol and nicotine as shown by urine tests
  • Current or recent (past month) use of cannabidiol products
  • History of allergy to cannabidiol
  • Significant alcohol-induced flushing after 1-2 drinks
  • Currently pregnant, breastfeeding, or planning pregnancy or breastfeeding
  • Living in institutional settings such as hospital, nursing home, or prison
  • Currently receiving treatment for alcohol use disorder such as therapy or anticraving medication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J 1H4

Actively Recruiting

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Research Team

K

Kelly Xiao, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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