Nearly one-third of the U.S. prison population has a history of heroin addiction. In March 2006, the directors of the Dana Foundation awarded a two-year $300,000 grant to the University of Pennsylvania to lead a five-site consortium pilot study to assess the feasibility of providing a long-acting form of the medical drug naltrexone to prevent heroin relapse among adults on parole or probation who have a history of heroin addiction. The rationale for this study was that naltrexone blocks the “high” from heroin, making it impossible to relapse.
Participants in the feasibility study receive monthly naltrexone injections for six months in addition to standard counseling therapy. They are tested again at 12 months to determine if they are heroin-free. Agreement to participate was explicitly not a condition for resolution of sentencing, probation or parole. The study requires that each of five consortium sites work with the local criminal justice system to enroll participants and collect data in a uniform format. The University of Pennsylvania, which designed the approach, is managing the consortium.
In April 2008, the Foundation received a report from the principal investigator at the University of Pennsylvania concluding that the pilot study has been successful. Each site has enrolled participants and collected uniform data. As the lead institution, Penn has enrolled the most participants and is the furthest along in studying them over time. The report includes enrollment, participant monitoring, and financial data from Penn and the principal investigator will provide data from the other sites as well.
Based on the data collected from this Dana-funded feasibility study, the National Institute on Drug Abuse (NIDA), one of the National Institutes of Health, has given a high priority score to an application for the consortium to undertake a large-scale study on the effectiveness of naltrexone in preventing heroin relapse and reincarceration among adult paroles and probationers. Final NIDA approval is expected in September 2008, with funding to begin in October 2008; however, Penn’s financial report indicates that all of the grant funds will have been expended by mid-June. Accordingly, Penn, as the lead institution in the consortium is requesting additional funds at this time to continue to study the enrolled population through October and to continue to develop the management and data collection and analyses systems necessary to conduct the planned large-scale study.