NCT00501631

ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence

Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	VIVITROL 380 mg	Administered via IM injection once every 4 weeks.
DRUG	Placebo for VIVITROL 380 mg	Administered via IM injection once every 4 weeks.

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2007-07-16
• Last updated: 2011-09-22
• Results posted: 2011-04-13