Dose-response Study of Apremilast in Women and Men With Alcohol Use Disorder

Description

This human laboratory study is a Phase 2 double-blind, placebo-controlled, dose-response, parallel group design which will compare apremilast (90mg/day vs 60mg/day) to placebo in non-treatment seeking adults meeting criteria for DSM 5 alcohol use disorders (n=120, 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 (90mg/day or 60mg/day) or placebo. Titration to steady state medication levels occur over 9 days (Day 1-9). Subjects will then complete three laboratory sessions (Days 10-24). 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 30-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.