RECRUITING

Alcohol Use Disorder and Cannabidiol

Conditions

Alcohol Use Disorder alcohol cannabidiol cbd cannabis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies

Quick Facts

Study Start:2023-04-30

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05613608

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Raeghan Mueller, PhD

CONTACT

3037242210

raeghan.mueller@cuanschutz.edu

Principal Investigator

Kent Hutchison, PhD

PRINCIPAL_INVESTIGATOR

University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Anschutz

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-30

Study Completion Date2027-04

Study Record Updates

Study Start Date2023-04-30

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

alcohol
cannabidiol
cbd
cannabis

Additional Relevant MeSH Terms

Alcohol Use Disorder