Conditions: Alcohol Dependence
Keywords: Addiction Alcoholism Inpatient detoxification
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief summary:
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

Detailed description:
The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.

Arms:
arm 1: Administered via intramuscular (IM) injection once every 4 weeks. arm 2: Administered via IM injection once every 4 weeks.

Interventions: intervention 1: VIVITROL 380 mg intervention 2: Placebo for VIVITROL 380 mg
Intervention descriptions: intervention 1: Administered via IM injection once every 4 weeks. intervention 2: Administered via IM injection once every 4 weeks.

Protocol document: