NCT07029529

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This human laboratory study is a Phase 2 double-blind, placebo-controlled, parallel group design which will compare apremilast (60mg/day) to placebo in non-treatment seeking adults meeting criteria for DSM 5 alcohol use disorders (n=80, 40 per cell, 50% females). Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be assigned to apremilast (60mg/day) or placebo. Titration to steady state medication levels occur over 6 days (Day 1-6). Subjects will then complete three laboratory sessions (Days 7-24). During each laboratory session, personalized imagery (within-subject factor, either stress or stimulation or neutral, order counterbalanced) will precede a 2-hour alcohol self-administration period. Participants will remain on study medication for a 28-day period, during which naturalistic drinking will be evaluated. No taper medication is needed. Following the discontinuation of medication (Day 30), participants will be assessed for an additional 1-month period. Adverse events are evaluated at each study appointment and will be tabulated.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Apremilast 60mg	Apremilast 60mg/day
OTHER	Placebo	Placebo

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-06-19
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study