Human Laboratory Study of Apremilast for Alcohol Use Disorder

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study ID
NCT07325266
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Matched Placebo Capsule
  • Apremilast — DRUG
    30 mg capsule

Study Details

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.

Key Dates

Start date
Apr 3, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oral Apremilast 60 mg/day
    Apremilast, 30mg per capsule, administered twice daily (AM/PM), Placebo, administered once daily (AM)
  • Active Comparator: Oral Apremilast 90 mg/day
    Apremilast, 30mg per capsule, 2 capsules (AM) and 1 capsule (PM)
  • Placebo Comparator: Oral Matched Placebo
    Placebo, capsule, 2 capsules (AM) and 1 capsule (PM)

Primary Outcome Measure

Alcohol Craving [ Time Frame: Week 4 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of CaliforniaLos AngelesCalifornia90095
Jessica Jenkins, MS
[email protected]
310-206-6756
Lara Ray, PhD (PRINCIPAL_INVESTIGATOR)
University of ColoradoAuroraColorado80045
Kristen Raymond
[email protected]
Joseph Schacht, PhD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22911
Eva Jenkins-Mendoza, BS
[email protected]
434-243-0562
Tracie Kostelac
434.243.0563
Nassima Ait-Daoud Tiouririne, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Substance use disorder
By specialty
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By research site
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