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.
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