Naltrexone in AUD Reward Drinkers

PHASE4RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2027

Conditions
Alcohol Use DisorderAlcoholism
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.

Trial Locations (1)

19104

RECRUITING

University of Pennsylvania Center for Studies of Addiction, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alkermes, Inc.

INDUSTRY

lead

University of Pennsylvania

OTHER

NCT05028062 - Naltrexone in AUD Reward Drinkers | Biotech Hunter | Biotech Hunter