Status:
RECRUITING
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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-controll...
Detailed Description
Participants with alcohol use disorder will receive treatment daily (600mg cannabidiol or placebo), each for 10 consecutive days, with a 2-week long washout period between treatments. Participants wil...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06512389
Start Date
August 16 2024
End Date
December 31 2026
Last Update
August 23 2024
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4