Human Laboratory Study of Apremilast for Alcohol Use Disorder

Recruiting Phase 2 Interventional Study
Alcohol Use Disorder Alcohol Misuse
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
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About This Trial
Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing. Secondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other me…
Trial Locations
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Eligibility Criteria
Inclusion Criteria (not exhaustive list): 1. Be at least 21 years of age. 2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity). 3. Have a BAC by breathalyzer equal to 0.000 when s…
Contacts

Megan Ryan, MBA

3014434225

mryan1@nih.gov

CONTACT