ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
Status:
Completed
Trial end date:
2003-09-01
Target enrollment:
Participant gender:
Summary
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted
in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical
Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive
intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg,
placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg
(VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.