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Extended-Release Naltrexone for Opioid Relapse Prevention in Criminal Justice Offenders

This study examines the impact of extended-release naltrexone on opioid relapse among adults involved in the US criminal justice system compared to usual care. Results show that extended-release naltrexone leads to longer time to return to opioid use, lower rate of opioid use, and higher rate of opioid-negative urine samples.

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Extended-Release Naltrexone for Opioid Relapse Prevention in Criminal Justice Offenders

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence May-June, 2016

  2. Featured Article Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders. Lee JD, et al. N Engl J Med. 2016;374(13):1232–1242.

  3. Study Objectives • To examine a 24-week course of extended-release naltrexone, compared with usual care, to determine impact on return to opioid use among adults involved in the US criminal justice system. www.aodhealth.org

  4. Study Design • Randomized, open-label trial across five sites for 24 weeks. • 153 participants received extended-release naltrexone. • 155 participants received usual care to prevent return to opioid use (brief counseling and referrals for community treatment programs). www.aodhealth.org

  5. Assessing Validity of an Article about Therapy • Are the results valid? • What are the results? • How can I apply the results to patient care? www.aodhealth.org

  6. Are the Results Valid? • Were patients randomized? • Was randomization concealed? • Were patients analyzed in the groups to which they were randomized? • Were patients in the treatment and control groups similar with respect to known prognostic variables? www.aodhealth.org

  7. Are the Results Valid?(cont‘d) • Were patients aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete? www.aodhealth.org

  8. Were patients randomized? • Yes. • Participants were randomized in a 1:1 ratio using an urn randomization procedure. www.aodhealth.org

  9. Was randomization concealed? • Yes. • “An independent, centralized, automated telephone system made the treatment assignments.” www.aodhealth.org

  10. Were patients analyzed in the groups to which they were randomized? • Yes. www.aodhealth.org

  11. Were the patients in the treatment and control groups similar? • Yes. The characteristics of the groups at baseline were similar. www.aodhealth.org

  12. Were patients aware of group allocation? • Yes, patients were aware of group allocation based on treatment received. www.aodhealth.org

  13. Were clinicians aware of group allocation? • Yes. www.aodhealth.org

  14. Were outcome assessors aware of group allocation? • Yes. www.aodhealth.org

  15. Was follow-up complete? • 119/153 (78%) randomized to receive extended-release naltrexone completed follow up at 24 weeks • 126/155 (81%) randomized to receive 155 participants received usual care completed follow up at 24 weeks www.aodhealth.org

  16. What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org

  17. How large and precise was the treatment effect? • During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to return to ≥ 10 days of opioid use (10.5 versus 5 weeks; hazard ratio, 0.49; 95% confidence interval [CI], 0.36-0.68), a lower rate of return to such use (43% versus 64%; odds ratio, 0.43; 95% CI, 0.28-0.65), and a higher rate of opioid-negative urine samples (74% versus 56%; odds ratio, 2.30; 95% CI, 1.48-3.54), compared with usual care. • Compared with the extended-release naltrexone group, more participants in the usual care group pursued opioid agonist treatment (OAT) during the trial (11% versus 37%), primarily after returning to opioid use. • There were no overdose events reported in the extended-release naltrexone group and 7 (3 fatal) in the usual care group. www.aodhealth.org 17

  18. How Can I Apply the Results to Patient Care? • Were the study patients similar to the patients in my practice? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs? www.aodhealth.org

  19. Were the study patients similar to those in my practice? • The trial was conducted across five sites in the US among people involved with the criminal justice system. • At baseline, participants preferred non-OAT approaches to treatment. • The mean age of participants was 44 years. They were: • 85% male • 77% black or Hispanic • 74% were on parole or probation • 65% had not used heroin or other opioids in the previous 30 days www.aodhealth.org

  20. Were all clinically important outcomes considered? • Yes. www.aodhealth.org

  21. Are the likely treatment benefits worth the potential harm and costs? • Costs were not reported. www.aodhealth.org

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