NCT02617628

Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objectives for this study is to offer tools to support improve healthcare and related outcomes and reduce the risk of relapse and recidivism for opiate addicted prisoners reentering into the community after release from correctional facilities. In this study the investigators examine a medication-assisted therapy (extended release naltrexone) that is likely to be acceptable to correctional facilities and opioid addicted prisoners and that can improve the outcomes achieved by the usual detoxification/treatment referral approach. The results may be used to facilitate policy changes that involve adding extended release naltrexone to correctional facility formularies for use before reentry, and collaborating with one or more outpatient treatment providers to maintain continuity of care. Two hundred (200) opioid addicted prisoners currently incarcerated in the Philadelphia Prison System, who meet study admission criteria and express an interest in extended release naltrexone treatment, who give informed consent and will be scheduled for release within 14 days of being randomized into the study will be enrolled. These 200 subjects will be stratified by sex (male/females), will be 18 years or older, and are not sentenced).

Conditions

• Opiate Dependence

Interventions

Type	Name	Description
DRUG	extended release naltrexone	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2015-12-01
• Last updated: 2021-01-28
• Results posted: 2020-04-15

Locations

1 site across 1 country: United States