title: A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence.
abstract: OBJECTIVE
  To compare the effectiveness and cost-effectiveness of unobserved versus observed dosing of patients seeking treatment of heroin dependence.
  
  
  METHODS
  Randomized controlled trial and cost-effectiveness analysis. Setting Specialist out-patient drug treatment centres in Australia.
  
  
  METHODS
  Heroin users seeking maintenance treatment.
  
  
  METHODS
  Participants were allocated randomly to observed or unobserved dosing for 3 months. All subjects received buprenorphine-naloxone and weekly clinical reviews.
  
  
  METHODS
  Primary end-points were retention in treatment and heroin use at 3 months. Costs of treatment were measured (in Australian dollars, AU$) and cost-effectiveness compared. Secondary outcomes included quality of life, psychological symptoms and use of non-opioid drugs.
  
  
  RESULTS
  A total of 119 subjects were randomized and analysed. At 3 months, 33/58 (57%) randomized to unobserved treatment, and 37/61 (61%) observed were retained (log-rank chi2 = 0.04, df = 1, P = 0.84). On an intention-to-treat analysis, reductions in days of heroin use in the preceding month, from baseline to 3 months, did not differ significantly; 18.5 days (95% CI: 21.8-15.3) and 22.0 days (95% CI: 24.3-19.7), respectively (Mann-Whitney U = 807.5, P = 0.13). The mean cost for the unobserved group was AU$1,663 (95% CI 1308-2017) per treatment episode, significantly less than the mean cost for the observed group at AU$2,138 (95% CI 1713-2562).
  
  
  CONCLUSIONS
  Retention and heroin use was not significantly different between observed and unobserved dosing groups. Attendance for observed dosing was not associated with worse retention. Treatment with close clinical monitoring, but no observation of dosing, was significantly cheaper and therefore significantly more cost-effective.
authors.affiliation: The Langton Centre, Surry Hills, NSW, Australia. james.bell@iop.kcl.ac.uk
authors.forename: James
authors.initials: J
authors.lastname: Bell
authors.forename: Marian
authors.initials: M
authors.lastname: Shanahan
authors.forename: Carolyn
authors.initials: C
authors.lastname: Mutch
authors.forename: Felicity
authors.initials: F
authors.lastname: Rea
authors.forename: Anni
authors.initials: A
authors.lastname: Ryan
authors.forename: Robert
authors.initials: R
authors.lastname: Batey
authors.forename: Adrian
authors.initials: A
authors.lastname: Dunlop
authors.forename: Adam
authors.initials: A
authors.lastname: Winstock
mesh_terms: D000328:Adult; D001315:Australia; D002047:Buprenorphine / Q000627:therapeutic use*; D000069479:Buprenorphine, Naloxone Drug Combination; D003362:Cost-Benefit Analysis; D023801:Directly Observed Therapy; D004338:Drug Combinations; D017048:Health Care Costs; D006556:Heroin Dependence / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D009270:Naloxone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D010349:Patient Compliance; D012646:Self Administration; D013223:Statistics as Topic