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RECRUITING
NCT07325266
PHASE2

Human Laboratory Study of Apremilast for Alcohol Use Disorder

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-03

Completion Date

2027-07-31

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Placebo

Matched Placebo Capsule

DRUG

Apremilast

30 mg capsule

Locations (3)

University of California

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

University of Virginia

Charlottesville, Virginia, United States