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Drug Court Practitioner Prepared by the National Association of Drug Court Professionals under subcontract to JBS International, Inc. (Contract No. HHSS2832007000031/HHSS28300002T) Extended-Release Naltrexone
By Joshua D. Lee, M.D., M.Sc., Assistant Professor, NYU School of Medicine
E xtended-release naltrexone (XR-NTX, aka VivitrolTM) is the newest FDA-approved medication for opioid and alcohol use disorders. It is the result of decades of federal and industry research into long-acting, safe, effective addiction medications. Naltrexone, a mu-opioid receptor antagonist, blocks many of the reinforcing effects of opioids (e.g., heroin, oxycodone) and alcohol, which in turn reduces illicit opioid and heavy alcohol use in treated individuals. A growing body of literature supports the feasibility and effectiveness of XR-NTX treatment among criminal justice populations. XR-NTX and Criminal Justice Populations
Most U.S. drug courts treat opioid-addicted
and probation populations, a recent five-site individuals and have access to some type of observational study showed opioid-dependent medication-assisted treatment, with 9 percent in parolees on XR-NTX had less ongoing illicit opioid a recent national survey reporting use of XR-NTX use and improved overall treatment outcomes as (Matusow et al., 2013). The feasibility and potential compared with treatment dropouts (Coviello et effectiveness of XR-NTX for alcohol-involved drug al., 2012). Pilot efforts in several jurisdictions are court participants has also been demonstrated. A providing XR-NTX to opioid-dependent jail and pilot study of XR-NTX as alcohol therapy among prison detainees prior to release. Preliminary data 32 offenders in Michigan and Missouri drug from a New York City randomized trial indicate courts demonstrated improved treatment and court attendance, reduced alcohol use, and fewer XR-NTX (combined with counseling during the rearrests versus matched controls (Finigan et al., week prior to jail release versus counseling alone) 2011). A similar case series in New Mexico showed reduced rates of relapse to heroin use by more than reduced drinking and fewer instances of triggering half (38 percent versus 88 percent; Lee et al., 2013). of car ignition interlock devices among 12 repeat International data assessing a related long-acting DUI offenders over 3 months of XR-NTX therapy naltrexone implant also demonstrated effectiveness (Lapham & McMillan, 2011). Considering parole in a prison reentry population (Lobmaier et al., 2010).
Prepared by the National Association of Drug Court Professionals under subcontract to JBS International, Inc. (Contract No. HHSS2832007000031/HHSS28300002T) Neurobiological Actions: How Does take consistently. The newer XR-NTX formulation
solves this daily adherence problem by means of an injection once a month. Once an injection Opioid receptors in the brain's reward center are is given, the participant receives the benefits of the main sites of activity for opioid molecules such naltrexone continuously for the next 4 weeks. as heroin and oxycodone and are important to the A goal of naltrexone medication treatment then overall effects of alcohol. A receptor is like a button becomes having participants receive an injection or a lock on the surface of a cell—when "pushed" or "unlocked" by another chemical, a reaction occurs, every month rather than take a pill every day. Once and a cascade of effects is set into motion. In the the injection is administered, cravings diminish case of opioid receptors in the brain, stimulation and the alcohol-opioid drug reward pathway leads to sensations of pleasure and reward. The is disrupted, enabling participants to focus on specific type of receptors most important to alcohol behavioral therapy and sober living.
and opioid addiction are mu-opioid receptors. Again, stimulating mu-opioid receptors, as heroin Logistics: How Is XR-NTX Provided?
or alcohol do, leads to feelings of pleasure and XR-NTX is administered as a monthly intramuscular reward (getting high or buzzed), while blocking the injection into the buttocks. It is similar in its mu-opioid receptor prevents these effects. Addicted tolerability and injection site side effects to other persons repeatedly use drugs and alcohol to get intramuscular injections such as risperidone (a the pleasurable reaction; therefore, if this effect is medication for schizophrenia) or antibiotics, which blocked, they are less likely to use.
are often given intramuscularly. Soreness and pain Naltrexone is a mu-opioid receptor blocker or at the injection site are common, though usually antagonist. When naltrexone blocks mu-opioid mild. Much rarer is a severe injection site reaction receptors, the pleasurable and rewarding effects resembling an abscess, which must be managed by of opioids and alcohol are greatly diminished or a medical provider. unavailable. A patient on a usual dose of naltrexone Like any prescription medication, XR-NTX must can use heroin or alcohol but will usually report be prescribed by a licensed practitioner such as a not feeling any heroin effects or high or not physician or nurse practitioner. It is not a controlled liking the taste of alcohol. Persons maintained substance and has no abuse or diversion potential, on naltrexone have a very low risk of continued so any medical provider can order, store, and illegal opioid use and are less likely to drink alcohol administer the medication. An injection may occur heavily compared to placebo (Anton et al., 2006; in any setting where a flu shot might be given, Garbutt et al., 2005; Krupitsky et al., 2011). Of typically a medical exam room. XR-NTX comes in great importance, persons treated with naltrexone an envelope-sized box, which should be stored in a are less likely to report alcohol and opioid cravings refrigerator. The patient typically lies down but can and the repeated thoughts and obsessions with also remain standing for the injection. The skin is drug use when they are not using.
cleaned with alcohol or iodine, and the medication is injected into the upper, outer portion of the XR-NTX: A Long-Acting Approach
buttock, alternating sides each month. Because The great challenge for drug courts with any form naltrexone is a long-acting opioid blocker, patients of addiction medication treatment is ensuring cannot be planning on opioid pain management or participants benefit from the medication on a daily be using opioids at the time of the first injection. basis. Medication nonadherence and relapse are This means patients using alcohol should confirm challenges, and naltrexone therapy is no different. they are not using opioids, and opioid patients It must be taken regularly to work. As a once-a-day must be detoxed and opioid-free prior to the first pill, naltrexone can be difficult for participants to injection. XR-NTX is then given every 4 weeks.
2 NDCI: The Professional Services Branch of NADCP
Practical Considerations: Who Should
schedule of psychotherapy, court and program attendance, Use XR-NTX?
urine or saliva testing, and vocational or educational programming. XR-NTX is a nonnarcotic with no abuse Which, if any, patients definitively do better on XR-NTX versus other therapies for alcohol or opioid addiction potential, meaning the issues of diversion and secondary is unknown. XR-NTX can be offered to any drug court gain are not significant concerns.
participant regardless of gender, ethnicity, or drug use history. Clearly, a participant choosing XR-NTX should find a monthly intramuscular injection to the buttock acceptable XR-NTX, an opioid receptor antagonist or blocker, is a and must be able to achieve an opioid-free state prior to the relatively new and novel approach to alcohol and opioid first injection, two conditions not all participants will meet. addiction treatment, administered as a long-acting monthly Most clinical trials have evaluated XR-NTX treatment in injection. A nonnarcotic and noncontrolled substance, conjunction with comprehensive behavioral therapy and XR-NTX can be prescribed by any medical prescriber and individual counseling in addition to medical management adapted to a wide range of treatment protocols for alcohol, counseling offered by the medical provider at the injection opioid, or alcohol-opioid coaddiction. Preliminary pilot visit (Garbutt et al., 2005; Krupitsky, 2011; Lee et al., programs of XR-NTX in drug court, jail, and community 2010). Voluntary 12-step involvement has been encouraged parole settings demonstrate its feasibility and potential in all these clinical trials. Outcomes of interest to drug effectiveness in alcohol- and drug-using populations. Thus court professionals are reduced opioid and alcohol use and XR-NTX offers drug courts an effective tool to discourage retention in treatment, both of which are more likely with program violations and promote successful outcomes for XR-NTX versus a placebo. XR-NTX can be paired with any their participants.
Anton, R. F., O'Malley, S. S., Ciraulo, D. A., Cisler, R. A., Lapham, S. C., & McMillan, G. P. (2011). Open-label pilot Couper, D., Donovan, D. M.,… Zweben, A. (2006). Combined study of extended-release naltrexone to reduce drinking and pharmacotherapies and behavioral interventions for alcohol driving among repeat offenders. Journal of Addiction Medicine, dependence. JAMA, 295(17), 2003–2017.
Coviello, D. M., Cornish, J. W., Lynch, K. G., Boney, T. Y., Lee, J. D., Grossman, E., DiRocco, D., Truncali, A., Hanley, K., Clark, C. A., Lee, J. D.,… O'Brien, C. P. (2012). A multisite Stevens, D.,… Gourevitch, M. N. (2010). Extended-release pilot study of extended-release injectable naltrexone treatment naltrexone for treatment of alcohol dependence in primary for previously opioid-dependent parolees and probationers. care. Journal of Substance Abuse Treatment, 39(1), 14–21.
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Lee, J. D., McDonald, R., Santana-Correa, N., McNeely, J., Finigan, M. W., Perkins, T., Zold-Kilbourn, P., Parks, J., & Grossman, E., Rotrosen, J., & Gourevitch, M. N. (2013, June). Stringer, M. (2011). Preliminary evaluation of extended- Extended-release naltrexone for opioid relapse prevention at release naltrexone in Michigan and Missouri drug courts. jail re-entry. Abstract presented at College for Problems of Journal of Substance Abuse Treatment, 41(3), 288–293.
Drug Dependence, San Diego, CA.
Garbutt, J. C., Kranzler, H. R., O'Malley, S. S., Gastfriend, D. R., Lobmaier, P. P., Kunoe, N., Gossop, M., Katevoll, T., & Waal, Pettinati, H. M., Silverman, B. L.,… Ehrich, E. W. (2005). H. (2010). Naltrexone implants compared to methadone: Efficacy and tolerability of long-acting injectable naltrexone Outcomes six months after prison release. European Addiction for alcohol dependence: A randomized controlled trial. JAMA, Research, 16(3), 139–145.
Matusow, H., Dickman, S. L., Rich, J. D., Fong, C., Dumont, Krupitsky, E., Nunes, E. V., Ling, W., Illeperuma, A., D. M., Hardin, C.,… Rosenblum, A. (2013). Medication Gastfriend, D. R., & Silverman, B. L. (2011). Injectable assisted treatment in U.S. drug courts: Results from a extended-release naltrexone for opioid dependence. Lancet, nationwide survey of availability, barriers and attitudes. Journal of Substance Abuse Treatment, 44(5), 473–480.
Drug Court Practitioner Fact Sheet 3
The Professional Services Branch of NADCP 1029 N. Royal Street, Suite 201 Alexandria, VA 22314Tel: 703.575.9400 Fax: 703.575.9402

Source: http://ndci.org/sites/default/files/nadcp/NDCI%26SAMHSA-Naltrexone-FS%20(1)%20(1).pdf