Evaluating cannabidiol for reducing alcohol cravings in people with alcohol use disorder
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder: A Human Laboratory Study
This study is testing if cannabidiol can help people with alcohol use disorder reduce their cravings for alcohol.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06512389 on ClinicalTrials.gov |
What this trial studies
This study assesses the effects of cannabidiol on alcohol consumption and craving in individuals diagnosed with alcohol use disorder. Participants will receive either cannabidiol or a placebo daily for 10 days, with a 2-week washout period between treatments. The study employs a double-blind, within-subject, placebo-controlled crossover design, allowing each participant to serve as their own control. Alcohol self-administration sessions will be conducted to measure the impact of the treatment on alcohol-related behaviors.
Who should consider this trial
Good fit: Ideal candidates are adults who meet DSM-5 criteria for alcohol use disorder and have a significant history of alcohol consumption.
Not a fit: Patients who do not meet the criteria for alcohol use disorder or those with severe liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel medication to help reduce cravings and consumption in individuals with alcohol use disorder.
How similar studies have performed: Other studies have explored the use of cannabinoids for addiction treatment, but this specific approach with cannabidiol for alcohol use disorder is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Matthew Sloan, MD — Centre for Addiction and Mental Health
- Study coordinator: Kelly Xiao, MSc
- Email: kelly.xiao@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.