Human Laboratory Study of Apremilast for Alcohol Use Disorder

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.

NCT Number	NCT07325266
Lead Sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions	Alcohol Use Disorder, Alcohol Misuse
Enrollment	100 participants
Start Date	2026-04-03
Primary Completion	2027-01-31 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-01