Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Public ClinicalTrials.gov record NCT02032433. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery. The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid). The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.
Study identification
- NCT ID
- NCT02032433
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 570 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 28, 2014
- Primary completion
- Jan 24, 2017
- Completion
- Jan 30, 2017
- Last update posted
- Aug 12, 2020
2014 – 2017
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tarzana Treatment Centers | Tarzana | California | 91356 | — |
| Gateway Community Services, Inc. | Jacksonville | Florida | 32201 | — |
| Avery Road Treatment Center | Rockville | Maryland | 20853 | — |
| Stanley Street Treatment and Resources | Fall River | Massachusetts | 02720 | — |
| Turquoise Lodge Hospital | Albuquerque | New Mexico | 87108 | — |
| Bellevue Hospital Center | New York | New York | 10016 | — |
| Maryhaven | Columbus | Ohio | 43207 | — |
| Evergreen Treatment Services | Seattle | Washington | 98134 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02032433, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2020 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02032433 live on ClinicalTrials.gov.