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Preliminary Evaluation of Extended-Release Naltrexone XR-NTX in Michigan and Missouri Drug Courts

Disclosure. This study was funded by Alkermes, Inc. under a contract with NPC Research. Research design, data collection, data analyses and report writing were performed primarily by NPC Research. Extended-release injectable naltrexone was developed with support from National Institute on Drug Abus

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Preliminary Evaluation of Extended-Release Naltrexone XR-NTX in Michigan and Missouri Drug Courts

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    1. Preliminary Evaluation of Extended-Release Naltrexone (XR-NTX) in Michigan and Missouri Drug Courts Mark Stringer Director, Missouri Division of Alcohol and Drug Abuse

    2. Disclosure This study was funded by Alkermes, Inc. under a contract with NPC Research.  Research design, data collection, data analyses and report writing were performed primarily by NPC Research. Extended-release injectable naltrexone was developed with support from National Institute on Drug Abuse Grant R43DA013531 and National Institute on Alcohol Abuse and Alcoholism Grant N43AA001002. Funding for the purchase of extended-release naltrexone for clients of Missouri Drug and DUI Courts was provided through an allocation by the Missouri Department of Corrections to the Division of Alcohol and Drug Abuse and an allocation from the Department of Mental Health Medication Assisted Treatment Fund for Uninsured.

    3. Background Alcohol dependence is a major public health problem, with a prevalence of ~15% in adults 18-45 years old (Glantz et al, 2009) Alcohol is a significant risk factor for criminal behavior ~ 40% of all violent crimes involve alcohol (Greenfield & Hennenberg, 2001) A 10% increase in heavy drinking rates is associated with ~ 2% increase in arrest rates among young adults (Carpenter & Dobkin, 2008) Carpenter C, Dobkin C. Drinking age, alcohol consumption, and crime (working paper). Accessible on the web at: http://people.ucsc.edu/~cdobkin/  Glantz MD et al. Psychol Med 2009;39:1365-77.  Greenfield LA et al. Alcohol Res Health 2001;25:20-31. Greenfield et al. Alc Res Health 2001;25:20-31.

    4. Drug Courts as a Response to This Problem The high proportion of offenders with substance abuse problems has led to the formation of drug courts Drugs (or “DUI”) courts use a combined systems approach to treating alcohol-dependent offenders The Drug Court team consists of personnel from the DA, Public Defender and Probation offices, as well as treatment providers, all under the leadership of a judge The goal is to provide integrated and seamless management of the alcoholic offender with a single point of accountability

    5. Extended-Release Injectable Naltrexone (XR-NTX): a Therapeutic Role in the Drug Court Setting? XR-NTX is an FDA-approved, injectable, once-per-month formulation of the opioid antagonist naltrexone (Vivitrol®) that has shown significant efficacy in treating alcoholism. In alcohol dependent patients who began XR-NTX with >4 days of abstinence, XR-NTX treatment (O’Malley et al, 2007): Resulted in nearly three-times the rate of 6-month abstinence vs. placebo (32% vs 11%; P=0.02) Decreased the median number of drinking days per month by 90% (P=0.005) Delayed time to first heavy drinking day >9-fold (>180 days vs 20 days; P=0.04) Decreased drinking on US holidays: Placebo patients drank on 1 in 5 days, vs. 0 for XR-NTX (P<0.05; Lapham, 2009) O'Malley S et al. J Clin Psychopharm 2007;27:507-512. Lapham S et al. J Subst Abuse Treat 2009; 36(1):1-6.

    6. Objectives and Methods Objectives To obtain pilot data from alcohol-dependent offenders in a drug court setting on the effectiveness of XR-NTX in maintaining abstinence and reducing recidivism Design This was a naturalistic, non-randomized, observational pilot study of outcome among alcohol-dependent offenders in a medication treatment group (XR-NTX) and a control group recruited from 3 Drug Court sites: Southgate MI, Warren MI and St. Louis MO.

    7. Methods Treatment groups Experimental group - treated with XR-NTX plus standard care in the community Matched control group - standard care in the community Outcomes Evaluated Compliance: number of missed drug court sessions per month Abstinence: the number of positive drug & alcohol tests per month proportion of offenders with >25% positive tests Re-Arrest Rate: annualized proportion of offenders with no new arrests (primary outcome) The effect of XR-NTX treatment (vs. standard care) was expressed in terms of relative risk reduction 7

    8. Baseline Characteristics of Treatment Sample

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