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Naltrexone in AUD Reward Drinkers
Sponsor: University of Pennsylvania
Summary
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.
Official title: Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-03-07
Completion Date
2028-07
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
XR-NTX 380 mg, intramuscular injection
Two doses of XR-NTX 380 mg, intramuscular injection.
Medical Management
All subjects will receive 8 weeks of medical management (Pettinati et al. 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.
Placebo intramuscular injection
Two doses of XR-NTX 380 mg, intramuscular injection.
Locations (1)
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States