At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 380 enrolled
Drug / intervention
NTX/BUP +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 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL®
In Brief
A Phase 3 clinical trial evaluating NTX/BUP, NTX/PBO-B, and 1 other intervention for Opioid Use Disorder. Completed, enrolled 380 participants across 20 sites.
Detailed Summary
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedSep 2015
Primary CompletionOct 2016
Study CompletionJan 2017
TodayJul 2026
First PostedSep 1, 2015
Enrollment StartAug 1, 2015
Primary CompletionOct 27, 2016
Study CompletionJan 9, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.8 years ago
Interventions
NTX/BUPdrug
Daily doses
NTX/PBO-Bdrug
Daily doses
PBO-N/PBO-Bdrug
Daily doses