Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

Principal Investigator: Shannon Gwin Mitchell, Ph.D
Co-Investigator: Robert P. Schwartz, M.D.
Co-Investigator: Marc J. Fishman, M.D.
Co-Investigator: Laura J. Dunlap, Ph.D.; Gary Zarkin, Ph.D.
Project Director: Elizabeth Buttrey
Funded By: National Institute on Drug Abuse
Grant #: 1R01DA033391-01A1
Total Project Period: 01/13 – 12/18

This study is a 6-month, two-group random assignment comparative effectiveness trial of XR-NTX v. Treatment as Usual (TAU) for 340 opioid-dependent youth ages 15-21. TAU will consist of the typical treatment approach provided to opioid-dependent youth in the US, namely buprenorphine for the treatment of opioid withdrawal followed by counseling with or without continued buprenorphine. The study’s aims are: (1) to determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of the following 3- and 6-month outcomes: a) days in treatment; b) opioid use; c) other drug (cocaine and marijuana) and alcohol use; d) criminal behavior and arrests; and e) relapse to DSM-IV defined opioid dependence; (2) to examine the impact of XR-NTX on HIV drug- and sex-risk behaviors at 3- and 6-month follow-up and HIV infection status at 6-months; and (3) to evaluate the cost, cost-effectiveness, and cost-benefit of XR-NTX v. TAU among opioid-dependent youth.