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1 conflict of interest Dr Keron Fletcher is a director of ZenaMed Ltd ZenaMed Ltd distributes the Zenalyser

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Presentation on theme: "1 conflict of interest Dr Keron Fletcher is a director of ZenaMed Ltd ZenaMed Ltd distributes the Zenalyser"— Presentation transcript:

1 1 conflict of interest Dr Keron Fletcher is a director of ZenaMed Ltd ZenaMed Ltd distributes the Zenalyser

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

3 3 why monitor? to optimise compliance to demonstrate compliance

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

5 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 6 the patient doesn’t want disulfiram 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) problemsolution

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

8 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 9 frequency of appointments % patients abstinent after 8 weeks once weekly clinicstwice weekly clinics disulfiram7%40% no disulfiram3%9% (Gerrein et al, 1973)

10 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 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 disulfiram6.7517.4 –supervised disulfiram8.030 –supervised disulfiram + CRA28.330 (Azrin, 1976)

12 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-treatment6.7% (Robichaud et al, 1979) Krampe, 2006- OLITA programme – multiple positive outcomes

13 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 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 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 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 17 monitoring concept carbon disulphide + acetone (in patient’s breath) = disulfiram = compliance = no alcohol

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

19 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 20 research study 1 –Zenalyser breath results from alcohol dependent patients no disulfiram vs 200mgs disulfiram daily –489 breath samples –was there any overlap in results between groups?

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

22 22 research study 2 –what is the sensitivity and specificity of 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 23 study 2 - results number of days post dose d = disulfiram c = controls n = sensitivity ( % ) specificity ( % ) 1 12d 3c 100 2 20d 2c 84.6100 3 22d 17c 88.2100

24 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 25 why monitor compliance? to optimise compliance to demonstrate compliance

26 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 27 Zenalyser in practise

28 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 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

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