Conditions: Alcoholism
Keywords: Alcoholism Alcohol dependence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 436
Healthy volunteers: no

Brief 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.

Detailed description:
Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs).

All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Medisorb naltrexone 380 mg intervention 2: Oral naltrexone 50 mg
Intervention descriptions: intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year. intervention 2: Tablet taken orally once daily for up to 1 year

Protocol document: