Extended-release naltrexone to prevent opioid relapse in criminal justice offenders

Joshua Lee, Peter D. Friedmann, Timothy W. Kinlock, Edward V. Nunes, Tamara Y. Boney, Randall A. Hoskinson, Donna Wilson, Ryan McDonald, John Rotrosen, Marc Gourevitch, Michael Gordon, Marc Fishman, Donna T. Chen, Richard J. Bonnie, James W. Cornish, Sean M. Murphy, Charles P. O'Brien

Research output: Contribution to journalArticle

Abstract

Background Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS In this five-site, open-label, randomized trial, we compared a 24-week course of extendedrelease naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. RESULTS A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extendedrelease naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P = 0.91). The rates of other prespecified secondary outcome measures-self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration-were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P = 0.02). CONCLUSIONS In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation.

Original languageEnglish (US)
Pages (from-to)1232-1242
Number of pages11
JournalNew England Journal of Medicine
Volume374
Issue number13
DOIs
StatePublished - Mar 31 2016

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Naltrexone
Criminal Law
Opioid Analgesics
Recurrence
Therapeutics
Urine
Confidence Intervals
Secondary Prevention
Odds Ratio
Unsafe Sex
Narcotic Antagonists
mu Opioid Receptor
Random Allocation
Cocaine
Self Report
Counseling

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Lee, J., Friedmann, P. D., Kinlock, T. W., Nunes, E. V., Boney, T. Y., Hoskinson, R. A., ... O'Brien, C. P. (2016). Extended-release naltrexone to prevent opioid relapse in criminal justice offenders. New England Journal of Medicine, 374(13), 1232-1242. https://doi.org/10.1056/NEJMoa1505409

Extended-release naltrexone to prevent opioid relapse in criminal justice offenders. / Lee, Joshua; Friedmann, Peter D.; Kinlock, Timothy W.; Nunes, Edward V.; Boney, Tamara Y.; Hoskinson, Randall A.; Wilson, Donna; McDonald, Ryan; Rotrosen, John; Gourevitch, Marc; Gordon, Michael; Fishman, Marc; Chen, Donna T.; Bonnie, Richard J.; Cornish, James W.; Murphy, Sean M.; O'Brien, Charles P.

In: New England Journal of Medicine, Vol. 374, No. 13, 31.03.2016, p. 1232-1242.

Research output: Contribution to journalArticle

Lee, J, Friedmann, PD, Kinlock, TW, Nunes, EV, Boney, TY, Hoskinson, RA, Wilson, D, McDonald, R, Rotrosen, J, Gourevitch, M, Gordon, M, Fishman, M, Chen, DT, Bonnie, RJ, Cornish, JW, Murphy, SM & O'Brien, CP 2016, 'Extended-release naltrexone to prevent opioid relapse in criminal justice offenders', New England Journal of Medicine, vol. 374, no. 13, pp. 1232-1242. https://doi.org/10.1056/NEJMoa1505409
Lee J, Friedmann PD, Kinlock TW, Nunes EV, Boney TY, Hoskinson RA et al. Extended-release naltrexone to prevent opioid relapse in criminal justice offenders. New England Journal of Medicine. 2016 Mar 31;374(13):1232-1242. https://doi.org/10.1056/NEJMoa1505409
Lee, Joshua ; Friedmann, Peter D. ; Kinlock, Timothy W. ; Nunes, Edward V. ; Boney, Tamara Y. ; Hoskinson, Randall A. ; Wilson, Donna ; McDonald, Ryan ; Rotrosen, John ; Gourevitch, Marc ; Gordon, Michael ; Fishman, Marc ; Chen, Donna T. ; Bonnie, Richard J. ; Cornish, James W. ; Murphy, Sean M. ; O'Brien, Charles P. / Extended-release naltrexone to prevent opioid relapse in criminal justice offenders. In: New England Journal of Medicine. 2016 ; Vol. 374, No. 13. pp. 1232-1242.
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abstract = "Background Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS In this five-site, open-label, randomized trial, we compared a 24-week course of extendedrelease naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. RESULTS A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extendedrelease naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95{\%} confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43{\%} vs. 64{\%} of participants, P<0.001; odds ratio, 0.43; 95{\%} CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74{\%} vs. 56{\%}, P<0.001; odds ratio, 2.30; 95{\%} CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46{\%} in each group, P = 0.91). The rates of other prespecified secondary outcome measures-self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration-were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P = 0.02). CONCLUSIONS In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation.",
author = "Joshua Lee and Friedmann, {Peter D.} and Kinlock, {Timothy W.} and Nunes, {Edward V.} and Boney, {Tamara Y.} and Hoskinson, {Randall A.} and Donna Wilson and Ryan McDonald and John Rotrosen and Marc Gourevitch and Michael Gordon and Marc Fishman and Chen, {Donna T.} and Bonnie, {Richard J.} and Cornish, {James W.} and Murphy, {Sean M.} and O'Brien, {Charles P.}",
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TY - JOUR

T1 - Extended-release naltrexone to prevent opioid relapse in criminal justice offenders

AU - Lee, Joshua

AU - Friedmann, Peter D.

AU - Kinlock, Timothy W.

AU - Nunes, Edward V.

AU - Boney, Tamara Y.

AU - Hoskinson, Randall A.

AU - Wilson, Donna

AU - McDonald, Ryan

AU - Rotrosen, John

AU - Gourevitch, Marc

AU - Gordon, Michael

AU - Fishman, Marc

AU - Chen, Donna T.

AU - Bonnie, Richard J.

AU - Cornish, James W.

AU - Murphy, Sean M.

AU - O'Brien, Charles P.

PY - 2016/3/31

Y1 - 2016/3/31

N2 - Background Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS In this five-site, open-label, randomized trial, we compared a 24-week course of extendedrelease naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. RESULTS A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extendedrelease naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P = 0.91). The rates of other prespecified secondary outcome measures-self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration-were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P = 0.02). CONCLUSIONS In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation.

AB - Background Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS In this five-site, open-label, randomized trial, we compared a 24-week course of extendedrelease naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. RESULTS A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extendedrelease naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P = 0.91). The rates of other prespecified secondary outcome measures-self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration-were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P = 0.02). CONCLUSIONS In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation.

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DO - 10.1056/NEJMoa1505409

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