Depot versus Oral Naltrexone Treatment of Opioid-Dependent Parolees – Follow-on

Lay Summary

Depot versus Oral Naltrexone Treatment of Opioid-Dependent Parolees - Follow-on

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.

Follow-on from earlier grant

Abstract

Depot versus Oral Naltrexone Treatment of Opioid-Dependent Parolees

Heroin addiction is a major public health problem for the United States. Approximately 1,000,000 Americans are addicted to heroin and most support their drug habit by crime. Thus, a large proportion of the 2.1 million Americans currently incarcerated include those with the disease of heroin addiction. The typical pattern for a heroin addict is to be arrested, convicted, serve time, leave prison and very rapidly become readdicted starting the cycle all over again. Naltrexone is a medication that blocks opiate receptors thus making it physically impossible for a heroin addict to relapse. This medication has been studied in clinical trials since 1973 and was approved by the FDA for the treatment of opiate addiction in 1985 and approved for alcoholism in 1995. It is a generic medication with no drug reps visiting physicians, no advertisements and thus, few doctors are aware of its existence. Very few heroin addicts have been treated with this medication and only one controlled study has been conducted in the criminal justice population.

The Center for Studies of Addiction at the University of Pennsylvania and Philadelphia VA Medical Center conducted a controlled study of parolees with a history of heroin addiction and found that the parolees randomized to naltrexone had less than half the reincarceration rate of the control group followed up six months after their release from prison. A major problem for the use of oral naltrexone is that the patient simply stops the medication and after a day or two is able to again get high from heroin. A depot preparation has recently become available. The purpose of the study, therefore, is to test the efficacy of depot naltrexone in a large population at five sites organized by the PLNDP (Physicians and Lawyers for a National Drug Policy). The current study will be a pilot study using funds provided by NIDA to the University of Pennsylvania to purchase depot naltrexone and funds provided by the Dana Foundation to support clinical care at the five sites. The pilot study will be an open study in which all parolees with a past history of heroin addiction will be offered the chance to participate in the study. Those who vounteer will be given monthly injections for six months and then followed up for an additional six months to determine whether or not they relapsed to heroin addiction. The group plans to apply for a cooperative clinical trial agreement through NIDA for an October 1, 2006 deadline based on the results of the pilot study, which will be conducted beginning in May 2006. The larger study will be a randomized controlled trial with at least 300 patients.