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
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.
CONDITIONS
Official 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 (past 12 months) DSM-5 diagnosis of alcohol use disorder with at least moderate severity.
- Have a blood alcohol concentration of 0.000 by breathalyzer when signing consent.
- Be seeking treatment for alcohol problems with a goal of abstinence or reduced drinking.
- Able to understand and provide written informed consent and complete study questionnaires in English.
- If female and of childbearing potential, agree to use approved birth control methods unless surgically sterile or postmenopausal.
- Willing to follow the investigational product dosing schedule.
- Complete all required assessments at screening and baseline.
- Have stable housing for at least two weeks before randomization and not at risk of losing it by week 6.
- No anticipated transportation or scheduling problems that would interfere with study participation through week 6.
- Provide contact information for someone who can reach you if you miss a clinic appointment.
- Expected by the investigator to complete the study protocol.
- Agree to attend all scheduled visits and participate in phone visits.
- If taking medication for depression, must be on a stable dose for at least two months before randomization and plan to continue during the study.
- Not currently taking apremilast and agree not to take any non-study apremilast during the study.
- Have normal kidney function with creatinine clearance ≥ 60 mL/min.
You will not qualify if you...
- Contact study site for specific exclusion criteria details.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here