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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 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 570 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02032433
The ClinicalTrials.gov registry entry for NCT02032433 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 570 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Extended-Release Naltrexone is the first listed.
NCT02032433 reports 0 study locations.
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.
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