Naltrexone in AUD Reward Drinkers
Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation
University of Pennsylvania
60 participants
Mar 7, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Two doses of XR-NTX 380 mg, intramuscular injection.
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.
Two doses of XR-NTX 380 mg, intramuscular injection.
Locations(1)
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NCT05028062