Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

NCT ID: NCT06512389

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2026-12-31

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-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.

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 will be randomized to receive placebo or cannabidiol first (in blocks of random size) so that equal number of participants are allocated to each sequence. Around day 8 of each treatment period, participants will complete an alcohol self-administration session in the laboratory to assess the effects of treatment on alcohol consumption and alcohol-related craving.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabidiol

10-day supply of 600 mg of CBD, taken orally twice daily

Group Type: EXPERIMENTAL

Oral solution

Intervention Type: DRUG

300 mg taken morning and evening

Placebo

10-day supply of 600 mg of placebo, taken orally twice daily

Group Type: PLACEBO_COMPARATOR

Oral solution

Intervention Type: DRUG

300 mg taken morning and evening

Interventions

Oral solution

300 mg taken morning and evening

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Sloan, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kelly Xiao, MSc

Role: CONTACT

kelly.xiao@camh.ca

416-535-8501 ext. 32447

Facility Contacts

Kelly Xiao, MSc

Role: primary

kelly.xiao@camh.ca

416-535-8501 ext. 32447

Other Identifiers

2021/102

Identifier Type: -

Identifier Source: org_study_id