NCT01218958

ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Medisorb® Naltrexone in Alcohol-Dependent Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 624 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All subjects received standardized biopsychosocial support therapy (BRENDA Approach \[Volpicelli, JR \[2001\]; Guilford Press: New York\]) at each visit. Subjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study ALK21-003EXT (NCT01218971). A second extension, Study ALK21-010 (NCT00156923), was conducted subsequent to ALK21-003EXT.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Medisorb naltrexone 190 mg	Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.
DRUG	Medisorb naltrexone 380 mg	IM injection once every 4 weeks for a total of 6 administrations.
DRUG	Placebo matching Medisorb naltrexone 190 mg	IM injection once every 4 weeks for a total of 6 administrations.
DRUG	Placebo matching Medisorb naltrexone 380 mg	IM injection once every 4 weeks for a total of 6 administrations.

Timeline

• Start date: 2002-02-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2010-10-13
• Last updated: 2017-07-11
• Results posted: 2010-12-07