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conflict of interest

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  1. conflict of interest Dr Keron Fletcher is a director of ZenaMed Ltd ZenaMed Ltd distributes the Zenalyser www.zenamed.co.uk

  2. a new technique for monitoring compliancewith disulfiram Dr Keron Fletcher Consultant Addictions Psychiatrist South Staffordshire & Shropshire Healthcare NHS Foundation Trust England

  3. to optimise compliance to demonstrate compliance why monitor?

  4. compliance • compliance is central to the effectiveness of any treatment compliance on placebo > non-compliance on disulfiram

  5. non-compliance • patient doesn’t want disulfiram (Wexberg, 1953; Hoft, 1961) • patient doesn’t take disulfiram (Baekeland et al, 1971; Fuller et al, 1986)

  6. they don’t want to stop drinking alcohol (despite multiple harms) exaggerated fear of side effects exaggerated fear of the disulfiram-ethanol reaction (DER) including death fear that supervision will cause increased conflict with partner motivational work, cue cards, listening and explanation reassure (mostly minor) reassure (about 700 times less fatal than continuing to drink alcohol!) reassure (opposite is true – e.g.Chick et al, 1992) the patient doesn’t wantdisulfiram problem solution

  7. the patient doesn’t take disulfiram • attempts to improve compliance • implants • frequency of appointments • contingency management • community reinforcement • supervised administration • monitoring

  8. implants • Wilson, 1975, Canada • fail to release adequate levels of disulfiram • adverse effects of implantation (infection, rejection) • controlled studies do not show superior outcomes for patients given implants (Bergstrom et al,1982; Morland et al, 1984; Johnsen et al. 1987)

  9. frequency of appointments • % patients abstinent after 8 weeks once weekly clinics twice weekly clinics disulfiram 7% 40% no disulfiram 3% 9% (Gerrein et al, 1973)

  10. contingency management • probation + disulfiram vs jail (Haynes, 1973; Brewer & Smith, 1983) • money deposits – money given to charity if patient fails to attend for disulfiram (Bigelow et al, 1976) • termination of care if fail to take disulfiram (Sereny et al, 1986) • for opiate and alcohol dependent patients disulfiram must be taken before methadone will be administered (Liebson & Bigelow, 1972)

  11. community reinforcement • Community Reinforcement Approach (CRA) • buddy • daily reporting procedure • group counselling • supervised disulfiram • “social motivation programme” • 6 months follow-up, number of days alcohol free in previous month single married • unsupervised disulfiram 6.75 17.4 • supervised disulfiram 8.0 30 • supervised disulfiram + CRA 28.3 30 (Azrin, 1976)

  12. supervised administration • supervised disulfiram >>> placebo • Wright and Moore, 1990 • Kristenson, 1992 • Chick, 1992 • Hughes & Cook, 1997 • Anton, 2001 • Mueser, 2003 • supervised disulfiram and employment outcomes • absenteeism rates • pre-treatment 9.8% • in-treatment 1.7% • post-treatment 6.7% (Robichaud et al, 1979) • Krampe, 2006 - OLITA programme – multiple positive outcomes

  13. is supervised disulfiram superior to alternatives? • recent comparative studies • De Sousa, 2004 - disulfiram > naltrexone • De Sousa, 2005 - disulfiram > acamprosate • Petrakis, 2005 - disulfiram > naltrexone depressed patients • De Sousa, 2008 - disulfiram > topiramate • Laaksonen, 2008 - disulfiram > naltrexone and acamprosate • Alho, 2009 - disulfiram > naltrexone and acamprosate

  14. monitoring • available for use in every day clinical settings • frequency of appointments • contingency management • community reinforcement • supervision • optimising compliance • monitoring: improves compliance (which improves outcomes) • monitoring: now available though new technology

  15. monitoring • monitoring plus feedback > no monitoring • monitoring plus feedback > monitoring minus feedback (Kofoed, 1987) • 35% claiming compliance were not taking disulfiram • 20% receiving supervised disulfiram were not taking it (Paulson, 1977) • swap disulfiram for similar looking tablet • put disulfiram under tongue to spit out later • vomit dissolved disulfiram soon after administration • difficult to get a supervisor • supervisor threatened by patient to give false indication of compliance • even a good supervisor can be deceived

  16. monitoring • methods of monitoring compliance • urinary diethylamine(Fuller & Niederhiser, 1981) • riboflavin, urinalysis(Fuller et al, 1983) • exhaled carbon disulphide(Paulson, 1977; Rychtarick, 1983)

  17. monitoring concept • carbon disulphide + acetone (in patient’s breath) = disulfiram = compliance = no alcohol

  18. ideal instrument • breath analyser • able to measure carbon disulphide and acetone • hand held • non-invasive • instant results • simple to operate

  19. the Zenalyser • all instrument criteria have been met with the Zenalyser, but…….. • does the Zenalyser produce unequivocal results when monitoring compliance? • needed patient trials

  20. research • study 1 • Zenalyser breath results from alcohol dependent patients no disulfiram vs 200mgsdisulfiram daily • 489 breath samples • was there any overlap in results between groups?

  21. study 1 - results Range: 27-40nmol/l Range: 374-518nmol/l

  22. research • study 2 • what is the sensitivity and specificityof the Zenalyser? • 391 breath samples from Edinburgh patients • tester blind to disulfiram status • 54 patients on disulfiram • 22 patients not taking disulfiram • results sent to Shrewsbury for blind assessment

  23. study 2 - results

  24. readings sample • “A breath test to assess compliance with disulfiram” • K Fletcher, E Stone, MW Mohamad, GC Faulder, RM Faulder, K Jones, D Morgan, J Wegerdt, • M Kelly, J Chick • Addiction, Volume 101, Issue 12,pages 1705–1710, December 2006

  25. to optimise compliance to demonstrate compliance why monitor compliance?

  26. demonstrating compliance • when patients want to prove compliance and abstinence status • relationships • employers • high risk – medical, military, “safety critical” • high absenteeism • high pay • courts • child protection • drink-drive offences – Michigan USA • alcohol-related crime • court-mandated disulfiram outcomes > voluntary disulfiram (Martin et al, 2004)

  27. Zenalyser in practise

  28. patient reactions to the Zenalyser • patients have commented: • that the “option” of missing some doses of disulfiram and having a few drinks was removed • careful monitoring would stop them cheating • pleased that doctors are making an effort to develop new ways of helping people with alcohol dependence • relieved that compliance can now be demonstrated by the doctor

  29. summary • disulfiram is an effective treatment for alcohol dependence and superior to other pharmacological alternatives when measures are taken to address compliance • monitoring can optimise compliance • the Zenalyser can objectively and accurately monitor disulfiram compliance with the potential • to improve treatment outcomes • to improve the management of high risk situations