title: Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders.
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 extended-release 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 extended-release 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. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Lee
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Peter D
authors.initials: PD
authors.lastname: Friedmann
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Timothy W
authors.initials: TW
authors.lastname: Kinlock
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Edward V
authors.initials: EV
authors.lastname: Nunes
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Tamara Y
authors.initials: TY
authors.lastname: Boney
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Randall A
authors.initials: RA
authors.lastname: Hoskinson
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Donna
authors.initials: D
authors.lastname: Wilson
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Ryan
authors.initials: R
authors.lastname: McDonald
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: John
authors.initials: J
authors.lastname: Rotrosen
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Marc N
authors.initials: MN
authors.lastname: Gourevitch
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Michael
authors.initials: M
authors.lastname: Gordon
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Marc
authors.initials: M
authors.lastname: Fishman
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Donna T
authors.initials: DT
authors.lastname: Chen
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Bonnie
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: James W
authors.initials: JW
authors.lastname: Cornish
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Sean M
authors.initials: SM
authors.lastname: Murphy
authors.affiliation: From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
authors.forename: Charles P
authors.initials: CP
authors.lastname: O'Brien
mesh_terms: D000328:Adult; D003153:Community Health Services; D003376:Counseling; D057237:Criminals; D003692:Delayed-Action Preparations; D062787:Drug Overdose; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage* / Q000009:adverse effects; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D055502:Secondary Prevention; D015819:Substance Abuse, Intravenous / Q000150:complications
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone