Actively Recruiting
Human Laboratory Study of Apremilast for Alcohol Use Disorder
Led by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Updated on 2026-05-01
100
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different maintenance doses of apremilast tablets on reducing alcohol craving in adults with moderate to severe alcohol use disorder (AUD). This phase 2 study aims to compare these doses after two weeks of daily use and also assesses other outcomes such as alcohol consumption, craving, negative consequences, symptoms of AUD, pain, sleep disturbances, depression, anxiety, quality of life, cigarette and nicotine use, cannabis use, study retention, and safety. Participants are randomly assigned to receive either apremilast 60 mg per day, apremilast 90 mg per day, or a matched placebo. The apremilast doses are given in capsules twice daily, with specific capsule counts in the morning and evening. The study uses a triple masking design to compare the effects of these treatments. The treatment period includes daily dosing, and assessments occur over several weeks. During the study, participants complete various assessments including self-reported alcohol use, craving scales, symptom evaluations, and quality of life measures at multiple time points. Laboratory tests include inflammatory marker analysis. Researchers monitor safety and retention throughout the study. The primary outcome measured is alcohol craving at week 4, with additional secondary outcomes recorded up to week 6. Participants are involved in scheduled visits and phone calls as part of the protocol.
CONDITIONS
Brief Title
Human Laboratory Study of Apremilast for Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 21 years of age.
- Have a current diagnosis of moderate to severe alcohol use disorder (AUD) with 4 or more symptoms in the past 12 months.
- Have a blood alcohol concentration of 0.000 by breathalyzer at consent.
- Be seeking treatment for alcohol problems and want to reduce or stop drinking.
- Be able to understand and provide informed consent, follow study instructions, and complete questionnaires in English.
- If female and able to become pregnant, agree to use effective birth control methods unless surgically sterile or postmenopausal.
- Agree to follow the study medication dosing schedule.
- Complete all required screening and baseline assessments.
- Have stable housing for at least 2 weeks before randomization and no risk of losing housing during the study.
- Have reliable transportation and availability to attend study visits through week 6.
- Not plan to move away during the study period.
- Provide contact information for someone who can help reach you if you miss appointments.
- Be expected by the investigator to complete the study protocol.
- Agree to the visit schedule and phone contacts without conflicts.
- If taking depression medication, must be on a stable dose for at least 2 months before randomization and plan to continue it during the study.
- Not currently taking apremilast and agree not to take non-study apremilast during the trial.
- Have normal kidney function with creatinine clearance at or above 60 mL per minute.
You will not qualify if you...
- Contact study site for exclusion criteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive oral doses of Apremilast or matched placebo capsules daily as part of the study intervention.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 3 locations
1
University of California
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
University of Virginia
Charlottesville, Virginia, United States, 22911
Actively Recruiting
Research Team
M
Megan Ryan, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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