title: Optimising the benefits of unobserved dose administration for stable opioid maintenance patients: follow-up of a randomised trial.
abstract: BACKGROUND
  The registration of combination buprenorphine/naloxone, a formulation designed to reduce risk of diversion, has led some Australian jurisdictional authorities to allow treatment without direct observation of dosing for stable, opioid-dependent patients.
  
  
  OBJECTIVE
  To compare two approaches (1) initiating treatment with observed dosing, then allowing patients who demonstrate stability to change to unobserved dosing; or (2) initiating patients with unobserved dosing, subsequently requiring those who fail to stabilize to change to observed treatment.
  
  
  METHODS
  This study builds on an RCT comparing efficacy of observed and unobserved treatment at 3 months. At the conclusion of the RCT, clinically "stable" subjects were allocated to continue without observed dosing, while those who did not demonstrate stability were allocated to observed dosing. Subjects were followed for a further 3 months. Primary end-point was retention in treatment.
  
  
  RESULTS
  Of 119 subjects randomised, 70 were retained in treatment to 3 months. Forty-five stable subjects were allocated to unobserved dosing, 25 to observation. Unstable subjects allocated to observed treatment were more likely to drop out thereafter (OR 2.14, 95% CI 1.09-4.19). There was a non-significant trend for people initiated with observed dosing to be better retained during the allocation phase; at 6 months, 13 subjects (22%) from the original unobserved group, and 22 (34%) from the observed group, were retained in treatment (chi2=2.10, 1 df, p=0.15).
  
  
  CONCLUSIONS
  Withdrawal of unobserved doses led to marked attrition from treatment. If access to unobserved dosing is to be restricted to stable patients, it appears preferable to initiate dosing with observation and allow unobserved doses for people who successfully stabilize, than to initiate with unobserved doses and transfer unstable patients to observation.
authors.affiliation: The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010, Australia. james.bell@iop.kcl.ac.uk <james.bell@iop.kcl.ac.uk>
authors.forename: James R
authors.initials: JR
authors.lastname: Bell
authors.forename: Anni
authors.initials: A
authors.lastname: Ryan
authors.forename: Carolyn
authors.initials: C
authors.lastname: Mutch
authors.forename: Robert
authors.initials: R
authors.lastname: Batey
authors.forename: Felicity
authors.initials: F
authors.lastname: Rea
mesh_terms: D000328:Adult; D001315:Australia; D002047:Buprenorphine / Q000008:administration & dosage / Q000627:therapeutic use; D023801:Directly Observed Therapy / Q000379:methods* / Q000523:psychology; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008691:Methadone / Q000627:therapeutic use; D009270:Naloxone / Q000008:administration & dosage / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000523:psychology / Q000534:rehabilitation*; D010352:Patient Dropouts / Q000523:psychology / Q000706:statistics & numerical data; D016016:Proportional Hazards Models; D055502:Secondary Prevention; D012646:Self Administration / Q000379:methods* / Q000523:psychology; D016320:Substance Abuse Treatment Centers; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine; D008691:Methadone