ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of
repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to
adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual
of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1
ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of
VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.