title: A randomised controlled trial of sublingual buprenorphine-naloxone film versus tablets in the management of opioid dependence.
abstract: BACKGROUND
  Buprenorphine-naloxone sublingual film was introduced in 2011 in Australia as an alternative to tablets. This study compared the two formulations on subjective dose effects and equivalence, trough plasma levels, adverse events, patient satisfaction, supervised dosing time, and impact upon treatment outcomes (substance use, psychosocial function).
  
  
  METHODS
  92 buprenorphine-naloxone tablet patients were recruited to this outpatient multi-site double-blind double-dummy parallel group trial. Patients were randomised to either tablets or film, without dose changes, over a 31 day period.
  
  
  RESULTS
  No significant group differences were observed for subjective dose effects, trough plasma buprenorphine or norbuprenorphine levels, adverse events and treatment outcomes. Buprenorphine-naloxone film took significantly less time to dissolve than tablets (173±71 versus 242±141s, p=0.007, F=7.67).
  
  
  CONCLUSIONS
  The study demonstrated dose equivalence and comparable clinical outcomes between the buprenorphine-naloxone film and tablet preparations, whilst showing improved dispensing times and patient ratings of satisfaction with the film.
authors: Langton Centre, South Eastern Sydney Local Health District, NSW 2010, Australia. nicholas.lintzeris@sesiahs.health.nsw.gov.au
authors: N
authors: N
authors: Lintzeris
authors: S Y
authors: SY
authors: Leung
authors: A J
authors: AJ
authors: Dunlop
authors: B
authors: B
authors: Larance
authors: N
authors: N
authors: White
authors: G R
authors: GR
authors: Rivas
authors: R M
authors: RM
authors: Holland
authors: L
authors: L
authors: Degenhardt
authors: P
authors: P
authors: Muhleisen
authors: M
authors: M
authors: Hurley
authors: R
authors: R
authors: Ali
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D002047:Buprenorphine / Q000008:administration & dosage* / Q000097:blood*; D002626:Chemistry, Pharmaceutical; D019468:Disease Management; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage* / Q000097:blood*; D009293:Opioid-Related Disorders / Q000097:blood* / Q000188:drug therapy*; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D013607:Tablets; D009270:Naloxone; D002047:Buprenorphine