Alcohol Use Disorder and Cannabidiol

• Status: Not yet recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

1. Must be ≥21 years old.

2. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).

3. Expresses desire to reduce or quit drinking.

4. Meets one of the following drinking criteria:

1. If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening

2. Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening

5. Able to attend in-person visits at the study site.

Exclusion Criteria:

1. Self-reported DSM-V diagnosis of any other substance use disorder.

2. Current nicotine use.

3. Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.

4. Daily cannabis use.

5. Uses CBD products for medical reasons.

6. Report having and being treated for a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.

7. Endorsing item 2 on the C-SSRS measure of suicide risk.

8. Currently taking any of the following medications:

1. Those known to have a major interaction with Epidiolex.

2. Acute treatment with any antiepileptic medications.

3. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).

9. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).

10. Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.

11. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.

12. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.

13. Current charges pending for a violent crime (not including DUI-related offenses).

14. Lack of a stable living situation.

15. Lack of access to internet.