Opiate Dependence Clinical Trial
Official title:
Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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