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RECRUITING
NCT05028062
PHASE4

Naltrexone in AUD Reward Drinkers

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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

Interventions

DRUG

XR-NTX 380 mg, intramuscular injection

Two doses of XR-NTX 380 mg, intramuscular injection.

BEHAVIORAL

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.

DRUG

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