CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
VIVITROL® 380 mg +1 moredrug
Likely dose
VIVITROL® 380 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00678418
NCT00678418Phase 3Completed
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Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence

Alkermes, Inc.·interventional·Posted May 15, 2008·Updated Feb 10, 2017

In Brief

A Phase 3 clinical trial evaluating VIVITROL® 380 mg and Placebo for Opiate Dependence. Completed, enrolled 250 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Dependence
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.1 years ago

Interventions

VIVITROL® 380 mgdrug

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.

Placebodrug

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.