Alcohol Use Disorder and Cannabidiol

Description

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 Overview

Study Details

Study overview

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.

Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies

Alcohol Use Disorder and Cannabidiol

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 5. Able to attend in-person visits at the study site.
  • 6. Participants reporting current nicotine use in any form will be included.
  • 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. Daily cannabis use.
  • 4. Uses CBD products for medical reasons.
  • 5. 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.
  • 6. Endorsing item 2 on the C-SSRS measure of suicide risk.
  • 7. 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).
  • 8. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
  • 9. 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.
  • 10. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
  • 11. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
  • 12. Current charges pending for a violent crime (not including DUI-related offenses).
  • 13. Lack of a stable living situation.
  • 14. Lack of access to internet.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Kent Hutchison, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

2027-04