60
Participants
Start Date
March 7, 2022
Primary Completion Date
July 31, 2026
Study Completion Date
December 31, 2027
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.
RECRUITING
University of Pennsylvania Center for Studies of Addiction, Philadelphia
Collaborators (1)
Alkermes, Inc.
INDUSTRY
University of Pennsylvania
OTHER