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Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing. Secondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
University of Virginia
Charlottesville, Virginia, United States
Start Date
February 1, 2026
Primary Completion Date
January 31, 2027
Completion Date
July 31, 2027
Last Updated
January 8, 2026
100
ESTIMATED participants
Placebo
DRUG
Apremilast
DRUG
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT05855668
NCT07071779
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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