NCT02696434

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Naltrexone	daily dosing
DRUG	Placebo	daily dosing
DRUG	Buprenorphine	daily dosing

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-11-01
• Completion: 2017-11-30
• First posted: 2016-03-02
• Last updated: 2019-02-12
• Results posted: 2019-02-12

Locations

9 sites across 1 country: United States