Recruiting
Phase 2
Phase 3

Cannabidiol

Sponsor:

University of Colorado, Denver

Code:

NCT05613608

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Placebo

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Study ID

NCT05613608

Start date

Apr 30, 2023

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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. 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).
5. Able to attend in-person visits at the study site.
6. Participants reporting current nicotine use in any form will be included.

Exclusion Criteria:

1. Self-reported DSM-V diagnosis of any other substance use disorder.
2. Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
3. Uses CBD products for medical reasons.
4. 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.
5. Endorsing item 2 on the C-SSRS measure of suicide risk.
6. 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).
7. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
8. 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.
9. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
10. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
11. Current charges pending for a violent crime (not including DUI-related offenses).
12. Lack of a stable living situation.
13. Lack of access to internet.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Full-Spectrum Cannabidiol

210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.

active comparator: Broad-Spectrum Cannabidiol

210mg/day of full-spectrum cannabidiol, containing 0.0% THC.

placebo comparator: Placebo

210mg/day of hemp seed oil with no cannabinoids present.

Interventions

Cannabidiol

The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.

Placebo

Placebo arm.

Primary outcome measure

  • Change in Drinks per Drinking Day [ Time Frame: 0-12 weeks ]
  • Change in Alcohol Use Disorder [ Time Frame: 0-12 weeks ]
  • Change in Alcohol Craving [ Time Frame: 0-12 Weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Raeghan Mueller, PhD

raeghan.mueller@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • alcohol
  • cannabidiol
  • cbd
  • cannabis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-15.