Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion 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)

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of drinks administered during the alcohol-self administration session;Peak breath alcohol concentration during the alcohol-self administration session;Craving at baseline as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.;Craving following the priming dose of alcohol as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.

Secondary Outcome Measures

Name	Time	Method
Subjective effects of alcohol during the alcohol self-administration session as measured by the Drug Effects Questionnaire.;Subjective effects of alcohol during the alcohol self-administration session as measured by the Brief Biphasic Alcohol Effects Scale;Safety and tolerability of CBD;Differences in alcohol consumption (measured by the Timeline Follow Back method) outside of the lab during treatment with CBD vs. placebo;Differences in alcohol craving (measured by Penn Alcohol Craving Scale) outside of the lab during treatment with CBD vs. placebo;Differences in self-reported anxiety (measured by modified Generalized Anxiety Disorder-7) outside of the lab during treatment with CBD vs. placebo