Actively Recruiting
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Led by Yale University · Updated on 2026-05-14
80
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
For this protocol, the investigators plan to collect data to evaluate apremilast (60mg/day) vs placebo in adults with Alcohol Use Disorders (AUD).
CONDITIONS
Official Title
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21-65 years
- Able to read and write English
- Meets DSM-5 criteria for current (past 6 months) Alcohol Use Disorder
- Males must drink more than 14 drinks per week and exceed 4 drinks per day at least twice per week
- Females must drink more than 7 drinks per week and exceed 3 drinks per day at least twice per week
- Drinking criteria met during a consecutive 30-day period prior to baseline
- Laboratory sessions scheduled to avoid major responsibilities the following day
- Able to take oral medications and willing to follow medication regimen
- Signed and dated informed consent form provided
- Willing to comply with all study procedures and available for the study duration
You will not qualify if you...
- Significant current medical conditions including neurological, cardiovascular, endocrine, thyroid, renal, liver diseases, seizures, delirium, hallucinations, or unstable conditions including HIV
- Current DSM-5 substance use disorder other than Alcohol Use Disorder or tobacco use disorder
- Positive urine drug screen for illicit drugs at intake
- Psychoactive drug use in past 30 days that compromises study integrity
- Women who are pregnant, nursing, or not using approved birth control methods unless surgically sterile or postmenopausal
- Suicidal, homicidal, or current mental illness within past 6 months such as schizophrenia, bipolar disorder, major depression, or anxiety disorders
- Only one member per household allowed
- Hypersensitivity to apremilast or use of cytochrome P450 enzyme inducers
- Use of drugs that may affect study outcomes such as disulfiram, naltrexone, acamprosate, or anticonvulsants
- Likely to have significant alcohol withdrawal during study or history of serious withdrawal
- Use of investigational drugs within 4 weeks before study
- Participation in other studies with additive blood sampling or interventions within past 8 weeks
- Currently in treatment for drinking or attempted to quit drinking within past 3 months
- History of repeated alcohol detoxification or serious withdrawal
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
M
Meaghan Lavery
CONTACT
S
Sabrina Coppola
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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