CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Buprenorphine/naloxonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02294253
NCT02294253Phase 3Completed

Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone: An Outpatient Detoxification for Opioid Dependence.

New York State Psychiatric Institute·interventional·Posted Nov 19, 2014·Updated Mar 11, 2020

In Brief

A Phase 3 clinical trial evaluating Buprenorphine/naloxone for Opioid Dependence. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 19, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.6 years ago

Interventions

Buprenorphine/naloxonedrug

30 day oral Buprenorphine/naloxone