Prevention of Relapse to Opioid Addiction using Long-acting Injectable Naltrexone

Principal Investigator: Timothy W. Kinlock, Ph.D.
Co-Investigator: Michael Gordon, D.P.A.
Co-Investigator: Marc J. Fishman, M.D.
Funded By: National Institute on Drug Abuse
Grant #: R01 DA024550-01A1
Total Project Period: 7/08 – 5/14

The purpose of this study is to determine whether a monthly injection of naltrexone is practical and useful in the prevention of relapse and when compared to treatment as usual. This collaborative project will take place in five treatment sites where there is a large population of parolees with a history of opiate addiction: 1) University of Pennsylvania, Philadelphia, PA: 2) Rhode Island Hospital, Providence, RI; 3) New York University/Bellevue, New York, NY; 4) Columbia University, New York, NY; and 5) Friends Research Institute, Baltimore, MD.

After determining that all volunteers are opiate free by urine test results and not currently opiate dependent using a naloxone test, they will be randomized to depot naltrexone or Treatment as Usual (TAU. Participants in both groups will be given identical follow up assessments monthly for six months with measures of opiate use by self-report, urine test and hair analysis. An additional random urine test will take place each month between monthly visits. Both groups will be re-evaluated six and 12 months later. The University of Pennsylvania will be the coordinating site and each site will have a randomization goal of 20 new patients per year over 3.5 to 4 years to accrue a total of 360 to 400 participants. Treatment outcome will be measured by urine tests, hair analysis, self-report and continuation in treatment. Both naltrexone and comparison groups will receive equivalent cash incentives to remain in the program. A benefit-cost analysis will be conducted to compare the costs of the treatment with the quantifiable benefits in terms of reduced crime, re-incarceration and medical services and increased employment.