title: Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.
abstract: At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection naltrexone (XR-naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-naltrexone.
  
  
  
  Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-naltrexone, consistent with official prescribing information for XR-naltrexone. Participants from both groups received behavioral therapy focused on medication adherence and a second dose of XR-naltrexone.
  
  
  
  Compared with participants in the buprenorphine-assisted detoxification condition, participants assigned to naltrexone-assisted detoxification were significantly more likely to be successfully inducted to XR-naltrexone (56.1% compared with 32.7%) and to receive the second injection at week 5 (50.0% compared with 26.9%). Both models adjusted for primary type of opioid use, route of opioid administration, and morphine equivalents at baseline.
  
  
  
  These results demonstrate the safety, efficacy, and tolerability of low-dose naltrexone, in conjunction with single-day buprenorphine dosing and adjunctive nonopioid medications, for initiating adults with opioid dependence to XR-naltrexone. This strategy offers a promising alternative to the high rates of attrition and relapse currently observed with agonist tapers in both inpatient and outpatient settings.
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Maria
authors.initials: M
authors.lastname: Sullivan
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Adam
authors.initials: A
authors.lastname: Bisaga
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Martina
authors.initials: M
authors.lastname: Pavlicova
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: C Jean
authors.initials: CJ
authors.lastname: Choi
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Kaitlyn
authors.initials: K
authors.lastname: Mishlen
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Carpenter
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Frances R
authors.initials: FR
authors.lastname: Levin
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Elias
authors.initials: E
authors.lastname: Dakwar
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: John J
authors.initials: JJ
authors.lastname: Mariani
authors.affiliation: From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
authors.forename: Edward V
authors.initials: EV
authors.lastname: Nunes
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000553:Ambulatory Care; D001521:Behavior Therapy; D002047:Buprenorphine / Q000008:administration & dosage*; D003000:Clonidine / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage*; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D012074:Remission Induction; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D002047:Buprenorphine; D009271:Naltrexone; D003000:Clonidine
keywords: Buprenorphine; Detoxification; Injectable Naltrexone; Naltrexone; Opioid Dependence; Outpatient