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Apremilast for Alcohol Use Disorder

This study is looking at how well a medication called apremilast (30 mg capsule) works to reduce alcohol craving in people with moderate to severe alcohol use disorder (AUD). You would be given either apremilast or a placebo (an inactive capsule that looks like the study drug). Researchers will compare how much alcohol craving is reduced after two weeks of daily dosing. To join, you must be at least 21 years old, have an AUD diagnosis, and have a breath alcohol content (BAC) of zero. The study aims to enroll 100 participants, but its current status is unclear.

Study design
This is an interventional study comparing apremilast to a placebo. It plans to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Alcohol craving will be measured at Week 4.

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NCT07325266

Human Laboratory Study of Apremilast for Alcohol Use Disorder

Recruiting
PHASE2Ages 21+InterventionalTreatment
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
~100 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:PlaceboApremilast

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alcohol Craving
Measured over Week 4

Conditions

Alcohol Use Disorder
Alcohol Misuse

Explore related trials

Alcohol use disorder

Where it's being run

3 sites across 3 states
California1
Colorado1
Virginia1

Study leadership

  • Daniel Falk, PhD · PRINCIPAL_INVESTIGATOR · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who to contact

Megan Ryan, MBA
[email protected]
3014434225
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

oral contraceptives,
contraceptive sponge,
patch,
double barrier (diaphragm/spermicidal or condom/spermicidal),
intrauterine contraceptive system,
etonogestrel implant,
medroxyprogesterone acetate contraceptive injection,
complete abstinence from sexual intercourse, and/or
hormonal vaginal contraceptive ring. 7. Be willing to adhere to the investigational product dosing schedule. 8. Complete all assessments required at screening and baseline. 9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 6. 10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 6. 11. Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical. 12. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the participant in case of a missed clinic appointment. 13. Be someone who in the opinion of the investigator would be expected to complete the study protocol. 14. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. 15. If taking a medication for depression, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:
SSRIs
Dual uptake inhibitors
SNRIs
Tricyclic antidepressants
MAOIs
Bupropion 16. Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study. 17. Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation.

What this trial measures

  • Alcohol CravingWeek 4

    The primary outcome measure of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among participants with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.