title: Opioid use and dropout in patients receiving oral naltrexone with or without single administration of injection naltrexone.
abstract: BACKGROUND
  Adherence to oral naltrexone has been poor and can be improved somewhat with behavioral therapy. We compared behavioral naltrexone therapy (BNT) to compliance enhancement (CE) and tested efficacy of single-dose injection naltrexone (XR-NTX; 384 mg) with behavioral therapies at further improving adherence to oral naltrexone.
  
  
  METHODS
  A 24-week, randomized, placebo-controlled trial (n=125) compared four treatment conditions following inpatient detoxification and oral naltrexone induction: (1) BNT+XR-NTX; (2) BNT+placebo injection; (3) CE+XR-NTX; and (4) CE+placebo injection. All participants were maintained on oral naltrexone throughout the trial. Primary outcome was retention in treatment.
  
  
  RESULTS
  Of 89 randomized participants, 78.7% (70/89) completed 4 weeks, 58.2% (54/89) completed 8 weeks, 47.2% (42/89) completed 12 weeks, and 25.8% (23/89) completed 24 weeks. A Cox proportional hazards regression modeled time to dropout as a function of treatment condition, baseline opioid dependence severity (bags per day of heroin use), and their interaction. Interaction of conditions by baseline severity was significant (X3(2)=9.19, p=0.027). For low-severity patients (≤ 6 bags/day), retention was highest in the BNT-XR-NTX group (60% at 6 months), as hypothesized. For high-severity (>6 bags/day) patients, BNT-XR-NTX did not perform as well, due to high early attrition.
  
  
  CONCLUSIONS
  For low-severity heroin users, single-dose XR-NTX improved long-term treatment retention when combined with behavioral therapy. In higher-severity opioid-dependent patients, XR-NTX was less helpful, perhaps because, combined with oral naltrexone, it produced higher blood levels and more withdrawal discomfort. When cost considerations recommend oral naltrexone following XR-NTX, the latter should be phased in slowly.
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: mas23@columbia.edu.
authors.forename: Maria A
authors.initials: MA
authors.lastname: Sullivan
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: amb107@columbia.edu.
authors.forename: Adam
authors.initials: A
authors.lastname: Bisaga
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: glassan@nyspi.columbia.edu.
authors.forename: Andrew
authors.initials: A
authors.lastname: Glass
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: mishlen@nyspi.columbia.edu.
authors.forename: Kaitlyn
authors.initials: K
authors.lastname: Mishlen
authors.affiliation: Columbia University, 722 W. 168th Street, MSPH Box 12, New York, NY 10032, United States. Electronic address: mp2370@columbia.edu.
authors.forename: Martina
authors.initials: M
authors.lastname: Pavlicova
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: carpent@nyspi.columbia.edu.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Carpenter
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: mariani@nyspi.columbia.edu.
authors.forename: John J
authors.initials: JJ
authors.lastname: Mariani
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: Frl2@columbia.edu.
authors.forename: Frances R
authors.initials: FR
authors.lastname: Levin
authors.affiliation: Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: nunesed@nyspi.columbia.edu.
authors.forename: Edward V
authors.initials: EV
authors.lastname: Nunes
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001521:Behavior Therapy / Q000379:methods; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D009293:Opioid-Related Disorders / Q000175:diagnosis* / Q000523:psychology / Q000628:therapy*; D010349:Patient Compliance / Q000523:psychology; D010352:Patient Dropouts / Q000523:psychology
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Injection naltrexone; Opiate dependence treatment; Opioid antagonist; Oral naltrexone; Pharmacotherapy trials