CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 146 enrolled
Drug / intervention
extended release naltrexonedrug
Likely dose
extended release naltrexone 380 mgfrom 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/NCT02617628
NCT02617628Phase 3Completed
CompareCT.gov

Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry

University of Pennsylvania·interventional·Posted Dec 1, 2015·Updated Jan 28, 2021

In Brief

A Phase 3 clinical trial evaluating extended release naltrexone for Opiate Dependence. Completed, enrolled 146 participants across 1 site.

Detailed Summary

This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of an injectable opiate addiction medication (extended release naltrexone) given before reentry into the community that might help to improve reconnection to healthcare and other support systems, and possibly help reduce recidivism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Dependence
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 1, 2015
Enrollment StartJan 1, 2016
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 10.6 years ago

Interventions

extended release naltrexonedrug

Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison, or either 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.