Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Yale University
Summary
For this protocol, the investigators plan to collect data to evaluate apremilast (60mg/day) vs placebo in adults with Alcohol Use Disorders (AUD).
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…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 21-65. 2. Able to read and write English. 3. Meets DSM-5 criteria for current (past 6 months) AUD. 4. Drinking criteria: males - drinks \> 14 drinks per week and exceeds 4 drinks per day at least twice per week; females - drinks \> 7 drinks per week and exceeds 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period prior to baseline. 5. Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration sessi…
Interventions
- DrugApremilast 60mg
Apremilast 60mg/day
- OtherPlacebo
Placebo
Location
- Yale UniversityNew Haven, Connecticut