CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 217 enrolled
Drug / intervention
Extended-Release Naltrexonedrug
Likely dose
Extended-Release Naltrexone 380mgfrom 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/NCT01999946
NCT01999946Phase 4Completed
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Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

NYU Langone Health·interventional·Posted Dec 3, 2013·Updated Jun 25, 2021

In Brief

A Phase 4 clinical trial evaluating Extended-Release Naltrexone for Heroin Dependence and Opioid-Related Disorders. Completed, enrolled 217 participants across 2 sites.

Detailed Summary

The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalistic comparison of XR-NTX vs. an established jail-based methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will compare related opioid treatment outcomes post-release across all arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeroin Dependence, Opioid-Related Disorders
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), Friends Research Institute, Inc., University of California, Los Angeles

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 3, 2013
Enrollment StartJun 27, 2014
Primary CompletionMay 28, 2019
Study CompletionDec 24, 2020
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 12.6 years ago

Interventions

Extended-Release Naltrexonedrug

Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.