RecruitingPhase 2

Human Laboratory Study of Apremilast for Alcohol Use Disorder

United States100 participantsStarted 2026-04-03

Plain-language summary

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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Be at least 21 years of age.
✓. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity).
✓. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
✓. Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.
✓. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
✓. Agree (if the participant is female and of childbearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
✓. Be willing to adhere to the investigational product dosing schedule.
✓. Complete all assessments required at screening and baseline.

What they're measuring

Alcohol Craving

Timeframe: Week 4

Trial details

NCT IDNCT07325266

SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Megan Ryan, MBA

3014434225 mryan1@nih.gov

View on ClinicalTrials.gov More Alcohol Use Disorder trials