NCT00678418

ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence. The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.

Detailed description

Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults. Subjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety, durability of effect, health economics, and quality of life (QOL) in the continuing study population for up to 1 year. At the conclusion of both parts, each completing subject will have received a total of up to 19 injections of study drug over approximately 1.5 years. Dosing was performed by the principal investigator or designated study staff member. All subjects received standardized, manual-based psychosocial support at each scheduled visit. Opioid use was tracked through urine drug testing and subjects' self reports. Other evaluations for efficacy and safety, health economics, and quality of life were routinely conducted throughout the study.

Conditions

• Opiate Dependence

Interventions

Type	Name	Description
DRUG	VIVITROL® 380 mg	Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.
DRUG	Placebo	Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-10-01
• Completion: 2010-11-01
• First posted: 2008-05-15
• Last updated: 2017-02-10
• Results posted: 2011-01-21

Locations

1 site across 1 country: Russia