At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 101 enrolled
Drug / intervention
Naltrexone +2 moredrug
Likely dose
Not stated in 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.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
In Brief
A Phase 3 clinical trial evaluating Naltrexone, Placebo, and 1 other intervention for Opioid Use Disorder. Completed, enrolled 101 participants across 9 sites.
Detailed Summary
This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of VIVITROL.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionNov 2017
Study CompletionNov 2017
TodayJul 2026
First PostedMar 2, 2016
Enrollment StartApr 1, 2016
Primary CompletionNov 1, 2017
Study CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.3 years ago
Interventions
Naltrexonedrug
daily dosing
Placebodrug
daily dosing
Buprenorphinedrug
daily dosing