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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06324435
Study type Interventional
Source Yale University
Contact Meaghan Lavery
Phone 203-737-2783
Email meaghan.lavery@yale.edu
Status Not yet recruiting
Phase Phase 1
Start date April 15, 2024
Completion date February 28, 2025

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