This study seeks to estimate the effectiveness of newly FDA-approved extended-release naltrexone (XR-NTX) for opioid relapse prevention among opioid dependent participants leaving a large urban jail. While methadone treatment is available in NYC jails, many heroin and other opioid users, including HIV and Hepatitis C (HCV) infected individuals, decline this treatment at arrest, and instead leave jail out-of-treatment and at extraordinarily high risk for immediate opioid relapse, fatal overdose, and HIV/HCV-related adverse outcomes, including resuming patterns of injection drug use and unsafe sex. XR-NTX, an injectable non-narcotic opioid antagonist with no abuse potential, which blocks the usual physiologic effects of heroin and other opioids for up to 4 weeks, constitutes a new pharmacotherapy option for individuals not opting for agonist medications. We propose a randomized trial of XR-NTX versus enhanced treatment-as-usual to establish XR-NTX?s effectiveness as re-entry opioid relapse and HIV/HCV risk prevention. Further, an important question is how XR-NTX compares to methadone maintenance standard-of-care, and this study will recruit an additional, non-randomized, quasi-experimental methadone cohort for comparative effectiveness purposes.

Public Health Relevance

This study addresses the large population of opioid-addicted persons, including a disproportionate number of HIV and Hepatitis C (HCV) infected individuals, cycling in and out of US jails and not accessing evidence-based medical treatment for opioid dependence or HIV/HCV risk reduction, including a new, long-acting medication, extended-release naltrexone (XR-NTX). We seek to evaluate the effectiveness of XR-NTX in a large urban jail setting, enrolling otherwise out-of-treatment individuals just as they leave jail and return to the community, when they are at high risk for relapse to heroin and illicit opioids and HIV/HCV risk behaviors, including drug injection and unsafe sex. In addition, we seek to compare participants receiving XR-NTX to those receiving methadone maintenance at jail release in order to compare XR-NTX to the current standard-of-care.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DA033336-01A1
Application #
8438049
Study Section
Risk, Prevention and Intervention for Addictions Study Section (RPIA)
Program Officer
Wiley, Tisha R A
Project Start
2013-06-01
Project End
2018-05-31
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
1
Fiscal Year
2013
Total Cost
$628,726
Indirect Cost
$257,796
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016