NCT07325266

Human Laboratory Study of Apremilast for Alcohol Use Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

• Alcohol Use Disorder
• Alcohol Misuse

Interventions

Type	Name	Description
DRUG	Placebo	Matched Placebo Capsule
DRUG	Apremilast	30 mg capsule

Timeline

• Start date: 2026-04-03
• Primary completion: 2027-01-31
• Completion: 2027-07-31
• First posted: 2026-01-08
• Last updated: 2026-04-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study