Naltrexone in AUD Reward Drinkers

This study is a phase IV, two-arm, randomized, double-blind, placebo-controlled study to assess whether individuals identified as primarily reward drinkers are significantly more likely to reduce heavy drinking if they receive XR-NTX than a matching placebo injection. Study subjects will receive monthly injections of long-acting injectable naltrexone 380 mg (4 mL) or matching placebo. All subjects will also receive 4 sessions of Medical Management (MM). Post-treatment follow-up visits will be conducted at 4 weeks after the scheduled completion of treatment.

NCT Number	NCT05028062
Lead Sponsor	University of Pennsylvania Collaborators: Alkermes, Inc.
Conditions	Alcohol Use Disorder, Alcoholism
Enrollment	60 participants
Start Date	2022-03-07
Primary Completion	2027-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-01-20