Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

Inclusion Criteria:

• Meets DSM-5 criteria for AUD.

• Meets drinking criteria of average weekly consumption > 10 standard drinks for womenand > 15 standard drinks for men over the past 90 days.

• Willing to take study medication and participate in laboratory sessions requiringself-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 bemore than 2 times the upper normal limit, and bilirubin should not be more than 1.5times 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 theeligibility and alcohol self-administration visit.

• Individuals who are capable of becoming pregnant: agree to the use of highlyeffective contraception during study participation and for an additional 28 daysafter the end of cannabidiol administration.

Exclusion Criteria:

• Clinical Institute Withdrawal Assessment (CIWA-Ar) score of 10 or above upon initialassessment

• History of severe alcohol withdrawal including withdrawal seizures, alcoholichallucinosis, 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 theinvestigator's opinion, makes the participant unsuitable for the study

• Current medical conditions, prescriptions, or over the counter medications thatinterfere with receiving the study drug or alcohol (based on the study physician'sassessment)

• Severe mental illness (e.g. active psychosis with ongoing delusions and/orhallucinations, active manic or hypomanic episodes, evidence of a majorneurocognitive disorder, etc.) and other substance use disorders (moderate orsevere; excluding tobacco use disorder) as determined by the qualified investigator

• Experiencing active suicidal ideation within the past 1 month and/or suicide attemptwithin the past 6 months

• Recent recreational drug use (assessed via urine toxicology screen) other thanalcohol 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 foraldehyde dehydrogenase deficiency)

• Currently pregnant or breastfeeding or intending to become pregnant or breastfeed.

• Currently institutionalized which refers to a person who lives in an institutionalcollective dwelling, such as a hospital, nursing home or prison, including aresident under custody (e.g., patient or inmate).

• Currently in treatment for AUD (e.g. Alcoholics Anonymous, group therapy, individualtherapy, on anticraving medication)