Extended-Release Naltrexone Reduces Opioid Relapse in Criminal Justice Clients

Summary and Comment |
March 30, 2016

Extended-Release Naltrexone Reduces Opioid Relapse in Criminal Justice Clients

  1. Peter Roy-Byrne, MD

Even though the benefit did not last beyond 6 months posttreatment and did not extend to other outcomes, the treatment represents a valuable advance.

  1. Peter Roy-Byrne, MD

Criminal justice clients who are opioid-dependent find it difficult to obtain opioid-replacement therapies and are at heightened risk for relapse. These researchers tested the usefulness in this population of extended-release naltrexone, an effective alternative to opioid replacement therapies, in a multisite, 24-week, open-label trial. The 308 opioid-dependent, community-living ex-prisoners, mostly heroin users with limited use in the previous 30 days, were randomized to usual care alone (relapse-prevention counseling and community support) or usual care plus monthly injections of manufacturer-supplied, extended-release naltrexone.

Naltrexone-treated participants had a longer time to relapse (10 vs. 5 weeks in controls), lower relapse rates (43% vs. 64%), and more biweekly opioid-negative urine samples (74% vs. 56%). The groups did not differ in self-reported use of other drugs or alcohol, in risky behaviors (sexual or injection-drug use), or in re-incarceration. At 78 weeks, group differences in outcomes were no longer seen.


In this difficult-to-treat population, extended-release naltrexone increased the likelihood of temporary recovery from opioid dependence (i.e., for as long as patients received the medication). The number needed to treat (relapse risk, 5) compares favorably with some of the most effective behavioral health treatments. The regime of monthly injections might allow easier re-integration into the community than would daily opioid replacement. However, the transient nature of the therapeutic effect and the absence of effects on other drug- and alcohol-related outcomes and on re-incarceration suggests that treatment needs to be broader and target other issues besides opioid dependence. Unfortunately, the availability of addiction-targeted psychosocial treatments in this population is limited.

Editor Disclosures at Time of Publication

  • Disclosures for Peter Roy-Byrne, MD at time of publication Equity Valant Medical Solutions Grant / Research support NIH-NIDA; NIH-NIMH Editorial boards Depression and Anxiety; UpToDate Leadership positions in professional societies Anxiety Disorders Association of America (Ex-Officio Board Member); Washington State Psychiatric Society (President)


Reader Comments (1)

JAMES RECHT Physician, Psychiatry, Community health center and private practice

Dr. Byrne's comment is not accurate. IM naltrexone did not "increase the likelihood of recovery from opioid dependence". It did lead to a relative decrease in the use of illicit opiates, but only during the first 6 months of treatment. The study's other major finding was that "prevention of opioid use by extended-release naltrexone did not persist through follow-up at week 52 and week 78, approximately 6 months and 12 months, respectively, after the treatment phase had ended. In addition, we did not detect a benefit of extended-release naltrexone on several important secondary outcomes, including rates of cocaine, heavy alcohol, and injection-drug use. Rates of self-reported reincarceration and days of incarceration through week 27 were also not significantly lower in the extended-release naltrexone group than in the usual-treatment group."

There are additional concerns here: this was an open-label study with significant industry funding. Several of the principal authors have significant conflicts of interest (details are provided online).

But the real elephant in this room is the shameful lack of access to long-term medication assisted treatment that has been shown conclusively, in multiple studies, to reduce overdose deaths, increase treatment adherence, and decrease recidivism. IM naltrexone constitutes a sort of poor man's opioid dependence treatment that doesn't achieve any of those crucial objectives.

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