Alcohol Use Disorder and Cannabidiol

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT05613608

Run by

University of Colorado, Denver

People needed

180

Starts

2023-04-30

Expected to finish

2027-04-01

Last updated by the study team

2026-06-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be ≥21 years old.
• 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).
• Expresses desire to reduce or quit drinking.
• If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 10 standard drinks per week prior to screening, or if a male respondent reports consuming 5 or more alcoholic drinks on at least one drinking day per week on average (4 or more if female).
• Able to attend in-person visits at the study site.
• Participants reporting current nicotine use in any form will be included.

You may not qualify if…

• Self-reported DSM-V diagnosis of any other substance use disorder.
• Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
• Uses CBD products for medical reasons.
• Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any other psychotic mental disorder.
• Endorsing item 2 on the C-SSRS measure of suicide risk.
• Currently taking any of the following medications:
• Those known to have a major interaction with Epidiolex.
• Acute treatment with any antiepileptic medications.
• Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
• Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
• 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.
• Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
• Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
• Current charges pending for a violent crime (not including DUI-related offenses).
• Lack of a stable living situation.
• Lack of access to internet.

Where it is running

• University of Colorado Anschutz — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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