title: A pilot randomised controlled trial of brief versus twice weekly versus standard supervised consumption in patients on opiate maintenance treatment.
abstract: OBJECTIVE
  Methadone maintenance remains the mainstay of treatment for opiate dependence in Scotland. Guidelines recommend supervised self-administration for at least 3 months, yet this is often interpreted as long-term supervision. However, there is no evidence base for deciding the optimal period of supervision. We tested the feasibility of conducting a randomised controlled trial (RCT) of different supervision models.
  
  
  METHODS
  Three armed pilot RCT, set in three Scottish treatment areas, recruited opiate-dependent patients who had received methadone treatment for 3 months. Participants were randomised to: (i) no supervision; (ii) twice weekly supervision; or (iii) daily supervision for further 3 months. As a pilot, key process measures were: recruitment rates, follow-up rates and treatment fidelity. We also wanted to estimate effect sizes of two co-primary outcomes for a full RCT: treatment retention and illicit heroin use. The recruitment target was 60 participants.
  
  
  RESULTS
  One hundred and two eligible patients were identified, 60 (59%) participated, and 46 followed up (77%). Study fidelity was good with two participants moving group. Those randomised to no supervision were significantly happier with their group allocation. No significant differences were found in primary outcomes, although retention decreased with increased supervision, while illicit heroin use was least in those most supervised.
  
  
  CONCLUSIONS
  It is possible to recruit and randomise participants to an RCT comparing different forms of supervised consumption. Pilot data suggest increased supervision may reduce illicit heroin use, but may decrease retention. This should now be tested in a large-scale multicentre RCT.
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK. r.holland@uea.ac.uk
authors.forename: Richard
authors.initials: R
authors.lastname: Holland
authors.forename: Catriona
authors.initials: C
authors.lastname: Matheson
authors.forename: Geraldine
authors.initials: G
authors.lastname: Anthony
authors.forename: Kennedy
authors.initials: K
authors.lastname: Roberts
authors.forename: Saket
authors.initials: S
authors.lastname: Priyardarshi
authors.forename: Ann
authors.initials: A
authors.lastname: Macrae
authors.forename: Eddie
authors.initials: E
authors.lastname: Whitelaw
authors.forename: Sivaram
authors.initials: S
authors.lastname: Appavoo
authors.forename: Christine
authors.initials: C
authors.lastname: Bond
mesh_terms: D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D006556:Heroin Dependence / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008691:Methadone / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D058850:Opiate Substitution Treatment / Q000379:methods*; D010865:Pilot Projects; D012606:Scotland; D016896:Treatment Outcome
chemical_list: D009292:Narcotic Antagonists; D008691:Methadone