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NCT02032433 · ClinicalTrials.gov registry record · Phase 4
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 570
- Enrollment target
NCT02032433: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT02032433 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 570 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02032433, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 570 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-repor
Interventions
- DRUG Extended-Release Naltrexone
- DRUG Buprenorphine-Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 570 participants |
| Start Date | 2014-01-29 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 4 |
What the finished NCT02032433 record still lists
NCT02032433 is an interventional study that assigns participants to a tested intervention. The registered 570 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Extended-Release Naltrexone is the first listed.
NCT02032433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02032433 about?
NCT02032433 is a clinical study titled "Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment". 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 i...
What is the current status of trial NCT02032433?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 570 participants. The study started on 2014-01-29. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02032433?
The interventions under investigation include: Extended-Release Naltrexone (DRUG), Buprenorphine-Naloxone (DRUG).
Who is sponsoring clinical trial NCT02032433?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02032433's enrollment target sits among peer trials
570 150th of 2000 higher than 1,851 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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