Trials / Completed
CompletedNCT02537574
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
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®
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NTX/BUP | Daily doses |
| DRUG | NTX/PBO-B | Daily doses |
| DRUG | PBO-N/PBO-B | Daily doses |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2016-10-27
- Completion
- 2017-01-09
- First posted
- 2015-09-01
- Last updated
- 2019-03-06
- Results posted
- 2019-01-09
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02537574. Inclusion in this directory is not an endorsement.