NCT01218997

ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Medisorb naltrexone 380 mg	Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.
DRUG	Oral naltrexone 50 mg	Tablet taken orally once daily for up to 1 year

Timeline

• Start date: 2003-08-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2010-10-13
• Last updated: 2011-01-04
• Results posted: 2010-12-13