Depot Versus Oral Naltrexone Treatment of Opioid-Dependent Parolees

Charles O'Brien, M.D., Ph.D.

University of Pennsylvania

Funded in March, 2006: $300000 for 3 years
LAY SUMMARY . ABSTRACT . BIOGRAPHY .

ABSTRACT

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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 representatives 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.  Those who volunteer 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.

INVESTIGATOR BIOGRAPHIES

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Charles O'Brien, M.D., Ph.D.

Charles P. O’Brien, M.D., Ph.D., is Kenneth E. Appel Professor of Psychiatry and Vice Chair of the Department of Psychiatry at the University of Pennsylvania.  He is also Vice Director of the Institute for Neurological Sciences and Director of Research for the Mental Illness Research, Education, and Clinical Center at the Philadelphia VA Medical Center.  He is trained in neurology, psychiatry, and addiction psychiatry.  His research has focused on basic mechanisms of addiction as well as the development of new medications to treat addiction.