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Naltrexone in AUD Reward Drinkers

NCT05028062 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Henry R Kranzler, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05028062 on ClinicalTrials.gov