NCT06324435

Apremilast for Alcohol Use Disorder Treatment in Women and Men

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (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 pilot data to evaluate apremilast (60mg/day) in adults with Alcohol Use Disorders (AUD).

Detailed description

This study is a Phase 1 open-label design to evaluate apremilast (60mg/day) in adults meeting criteria for DSM-5 alcohol use disorders (n=10). Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be assigned to apremilast (60mg/day). Titration to steady state medication levels will occur over 6 days (Day 1-6). Subjects will then complete two laboratory sessions and a cue-reactivity session (Days 7-21). During each laboratory session, personalized imagery (within- subject factor, either stress or neutral/relaxing, order counterbalanced) will precede a 2-hour alcohol self-administration period. No taper medication is needed. Following the medication discontinuation (Day 22), subjects will be contacted to assess any side effect from discontinuing medication (Day 36). Adverse events are evaluated at each study appointment and will be tabulated.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Apremilast	60mg/day

Timeline

• Start date: 2024-05-08
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2024-03-22
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study