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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 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 30 participants.

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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.

Interventions

  • DRUG Buprenorphine/naloxone

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2014-09
Est. Completion 2017-12
Phase Phase 2

What the Registry Record Tells You About NCT02294253

The ClinicalTrials.gov registry entry for NCT02294253 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Buprenorphine/naloxone is the first listed.

NCT02294253 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.