drugset / Trial / NCT01999946

Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

NCT01999946

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-06-27
Primary completion
2019-05-28
Completion
2020-12-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 380 mg Intramuscular

Indications