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Harm Reduct J. 2006 Sep 27;3:28. doi: 10.1186/1477-7517-3-28.

Methodology for the Randomised Injecting Opioid Treatment Trial (RIOTT): evaluating injectable methadone and injectable heroin treatment versus optimised oral methadone treatment in the UK.

Harm reduction journal

Nicholas Lintzeris, John Strang, Nicola Metrebian, Sarah Byford, Christopher Hallam, Sally Lee, Deborah Zador,

Affiliations

  1. Institute of Psychiatry, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. [email protected]

PMID: 17002810 PMCID: PMC1613238 DOI: 10.1186/1477-7517-3-28

Abstract

Whilst unsupervised injectable methadone and diamorphine treatment has been part of the British treatment system for decades, the numbers receiving injectable opioid treatment (IOT) has been steadily diminishing in recent years. In contrast, there has been a recent expansion of supervised injectable diamorphine programs under trial conditions in a number of European and North American cities, although the evidence regarding the safety, efficacy and cost effectiveness of this treatment approach remains equivocal. Recent British clinical guidance indicates that IOT should be a second-line treatment for those patients in high-quality oral methadone treatment who continue to regularly inject heroin, and that treatment be initiated in newly-developed supervised injecting clinics. The Randomised Injectable Opioid Treatment Trial (RIOTT) is a multisite, prospective open-label randomised controlled trial (RCT) examining the role of treatment with injected opioids (methadone and heroin) for the management of heroin dependence in patients not responding to conventional substitution treatment. Specifically, the study examines whether efforts should be made to optimise methadone treatment for such patients (e.g. regular attendance, supervised dosing, high oral doses, access to psychosocial services), or whether such patients should be treated with injected methadone or heroin. Eligible patients (in oral substitution treatment and injecting illicit heroin on a regular basis) are randomised to one of three conditions: (1) optimized oral methadone treatment (Control group); (2) injected methadone treatment; or (3) injected heroin treatment (with access to oral methadone doses). Subjects are followed up for 6-months, with between-group comparisons on an intention-to-treat basis across a range of outcome measures. The primary outcome is the proportion of patients who discontinue regular illicit heroin use (operationalised as providing >50% urine drug screens negative for markers of illicit heroin in months 4 to 6). Secondary outcomes include measures of other drug use, injecting practices, health and psychosocial functioning, criminal activity, patient satisfaction and incremental cost effectiveness. The study aims to recruit 150 subjects, with 50 patients per group, and is to be conducted in supervised injecting clinics across England.

References

  1. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Nov 5;811(1):47-52 - PubMed
  2. Drug Alcohol Rev. 1992;11(1):35-42 - PubMed
  3. Drug Alcohol Depend. 2006 Jun 28;83(2):174-80 - PubMed
  4. Health Policy. 1996 Jul;37(1):53-72 - PubMed
  5. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003410 - PubMed
  6. Addiction. 2003 Mar;98(3):291-303 - PubMed
  7. Addiction. 1998 Mar;93(3):337-47 - PubMed
  8. Ther Drug Monit. 2002 Aug;24(4):457-70 - PubMed
  9. Eur Addict Res. 2000 Sep;6(3):115-22 - PubMed
  10. Drug Alcohol Depend. 1998 Aug 1;51(3):253-63; discussion 267-8 - PubMed
  11. BMJ. 1996 Jan 13;312(7023):71-2 - PubMed
  12. Addiction. 2002 Sep;97(9):1155-61 - PubMed
  13. Addiction. 2005 Dec;100(12):1832-9 - PubMed
  14. Med Care. 1992 Jun;30(6):473-83 - PubMed
  15. Lancet. 1999 May 8;353(9164):1543-4 - PubMed
  16. Pain. 2003 Oct;105(3):499-506 - PubMed
  17. Acta Psychiatr Scand. 1983 Jun;67(6):361-70 - PubMed
  18. Biol Psychiatry. 2003 Oct 15;54(8):854-61 - PubMed
  19. Acta Anaesthesiol Scand Suppl. 1982;74:66-9 - PubMed
  20. BMJ. 1996 Aug 3;313(7052):270-2 - PubMed
  21. Health Policy. 1990 Dec;16(3):199-208 - PubMed
  22. Addiction. 2003 Apr;98(4):385-6 - PubMed
  23. Drug Alcohol Depend. 2006 Feb 28;81(3):231-9 - PubMed
  24. Drug Alcohol Depend. 2006 Jan 4;81(1):47-54 - PubMed
  25. BMJ. 1995 Apr 29;310(6987):1085-6 - PubMed
  26. Ann Intern Med. 2002 Sep 17;137(6):501-4 - PubMed
  27. Pain. 1986 Jun;25(3):297-312 - PubMed
  28. Addiction. 1998 Dec;93(12):1857-67 - PubMed
  29. Addiction. 2000 Feb;95(2):285-7 - PubMed
  30. Addiction. 2000 Nov;95(11):1631-45 - PubMed
  31. Cochrane Database Syst Rev. 2003;(2):CD002209 - PubMed
  32. BMJ. 1998 Jul 4;317(7150):13-8 - PubMed
  33. Br J Addict. 1992 May;87(5):733-42 - PubMed
  34. Clin Pharmacol Ther. 2002 Nov;72(5):536-45 - PubMed
  35. Arch Gen Psychiatry. 1980 Aug;37(8):877-84 - PubMed
  36. Addiction. 2001 Apr;96(4):547-53 - PubMed

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