Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07029529
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Apremilast 60mg — DRUG
    Apremilast 60mg/day
  • Placebo — OTHER
    Placebo

Study Details

For this protocol, the investigators plan to collect data to evaluate apremilast (60mg/day) vs placebo in adults with Alcohol Use Disorders (AUD).

Key Dates

Start date
May 12, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Apremilast 60mg/day
    Apremilast 60mg/day. Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Day 1 10mg AM; Day 2 10mg AM, 10mg PM; Day 3 10mg AM, 20mg PM; Day 4 20mg AM, 20mg PM; Day 5 20 mg AM, 30mg PM; Day 6 30mg AM, 30mg PM. Once at steady state, administration is orally twice daily at 8:00 AM (30mg) and 8:00 PM (30mg).
  • Placebo Comparator: Placebo
    Administered orally twice daily at 8:00 AM and 8:00 PM.

Primary Outcome Measure

Alcohol Consumption [ Time Frame: Lab Sessions (Days 10, 17 & 24) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Meaghan Lavery
[email protected]
203-737-2783
Sabrina Coppola
[email protected]
203-737-2827

Find similar trials in New Haven, CT

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Yale University· New Haven, CT

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