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NCT02294253 · ClinicalTrials.gov registry record · Phase 2
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02294253: Completed Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT02294253 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02294253, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The investigators will randomize 50 opioid-dependent participants who have initially failed outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day stabilization and twice weekly during taper phase, and all patients who successfully complete the detoxification will be offered induction onto XR-NTX. All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication. The primary outcome of this study will be percentage of patients successfully inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or dropout.
Primary Outcome
Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper.
Interventions
- DRUG Buprenorphine/naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-09 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
What the finished NCT02294253 record still lists
NCT02294253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine/naloxone is the first listed.
NCT02294253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02294253 about?
NCT02294253 is a clinical study titled "Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone". The investigators will randomize 50 opioid-dependent participants who have initially failed outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day stabilization and twice week...
What is the current status of trial NCT02294253?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2014-09. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02294253?
The interventions under investigation include: Buprenorphine/naloxone (DRUG).
Who is sponsoring clinical trial NCT02294253?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02294253's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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