Phase
Condition
Alcohol Dependence
Substance Abuse
Alcohol Use Disorder
Treatment
Placebo
Cannabidiol
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 perweek prior to screening; if female, reports drinking, on average, at least 10standard drinks per week prior to screening.
Able to attend in-person visits at the study site.
Participants reporting current nicotine use in any form will be included.
Exclusion
Exclusion Criteria:
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.
Daily cannabis use.
Uses CBD products for medical reasons.
Self-reports or indicates having a serious DSM-V psychiatric disorder, includingpanic disorder, obsessive/compulsive disorder, post-traumatic stress disorder,bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any otherpsychotic 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, deliriumtremens).
Clinically significant medical problems in the last six months, such ascardiovascular, renal, gastrointestinal, or endocrine problems, that would impairparticipation 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 areliable 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.
Study Design
Study Description
Connect with a study center
University of Colorado Anschutz
Aurora, Colorado 80045
United StatesActive - Recruiting
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