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DISULFIRAM Comparative Studies and Experiences from Clinical Practice . Dr. Avinash De Sousa. My work in India. State government aided hospital. Private psychiatric set up – nursing home . Out patient private practice. Private general hospital with a large psychiatric set up.

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Disulfiram comparative studies and experiences from clinical practice

DISULFIRAM Comparative StudiesandExperiences from Clinical Practice

Dr. Avinash De Sousa


My work in india
My work in India

  • State government aided hospital.

  • Private psychiatric set up – nursing home.

  • Out patient private practice.

  • Private general hospital with a large psychiatric set up.


Alcohol dependence in india
Alcohol Dependence in India

  • No major research available on long term management till last five years.

  • Few doctors interested in specializing in addiction medicine.

  • Indian culture and alcohol dependence.


Disulfiram in india
Disulfiram in India

  • Cheaper alternative to Naltrexone, Acamprosate and Topiramate.

  • Alcoholism is a very rampant problems and most patients are the sole bread winners.

  • Abstinence is very important for work.

  • Lack of aided psychiatric services.


Disulfiram in india1
Disulfiram in India

  • Though cheaper – few psychiatrists are comfortable with usage.

  • Side effects are rare – hepatotoxicity or neuropathy.

  • Complicated alcohol withdrawals are common in our practice.

  • Disulfiram induced confusion or psychosis.


The indian studies
The Indian Studies

  • Three open randomized trials (2004-2008)

    Naltrexone VS Disulfiram

    Acamprosate VS Disulfiram

    Topiramate VS Disulfiram

  • Conditions in the study were similar to routine clinical practice in India.

  • All patients – underwent detoxification.

  • Randomized but open study.


Inclusion criteria
Inclusion Criteria

  • Age between 18-65 years.

  • DSM-IV criteria for alcohol dependence.

  • All had a stable and supportive family environment.

  • One responsible family member.

  • Importance of supervised Disulfiram therapy


Exclusion criteria
Exclusion Criteria

  • Other substance use disorders other than Nicotine Dependence.

  • Any co-morbid psychiatric disorder.

  • Any medical condition that would interfere with compliance.

  • Elevated liver functions.

  • Previous treatment with the 2 drugs of the study.


Methodology
Methodology

  • Subjects informed about the study and the drugs involved.

  • Need for a family member to be present on regular follow up.

  • Importance of psychoeducation in Disulfiram therapy.


Procedure assessments
Procedure & Assessments

  • Addiction Severity Index.

  • Severity of Alcohol Dependence Scale.

  • Scale to measure the 3 parameters of craving frequency, duration and intensity – (Anton).

  • Baseline liver function tests.

  • Calendar to record alcohol consumption.


Dose of medication used
Dose of medication used

  • 50mg of Naltrexone once a day.

  • 250mg of Disulfiram once a day.

  • 666mg of Acamprosate thrice daily.

  • 50mg Topiramate thrice daily.

  • NTX and DSF taken as a single daily dose in the morning after breakfast with a family member to observe that the patient takes the medicine.


Follow ups
Follow ups

  • Weekly for the first 3 months.

  • Fortnightly till the end of the study.

  • Transport paid by us – other incentive offered.

  • Supportive group psychotherapy – once a week – less structured than in a classical de-addiction programme – emphasis on compliance.


Additional medications
Additional medications

  • Sertraline 50-100mg and

  • Escitalopram5-10mg in case of depression.

  • Duloxetine 20-40mg per day in the Topiramate study.

  • Zolpidem 5-10mg at night in case of insomnia.

  • No benzodiazepines were prescribed.


Outcome measures
Outcome measures

  • Accumulated days of abstinence.

  • Days until the first relapse (defined as consuming more than 5 alcoholic drinks or 40gm alcohol in 24 hours).


Outcome measures1
Outcome Measures

  • Craving measures.

  • GGT measured every 3 months.

  • Discontinuation of treatment.

  • Drop out from the study


Disulfiram vs naltrexone alcohol alcoholism 2004 39 6 528 531
DisulfiramVSNaltrexone(Alcohol & Alcoholism 2004 ; 39(6) : 528-531)






Disulfiram vs acamprosate alcohol alcoholism 2005 40 6 545 548
DisulfiramVSAcamprosate(Alcohol & Alcoholism 2005 ; 40(6) : 545-548)






Disulfiram vs topiramate j subs abuse treatment 2008 34 460 463
DisulfiramVSTopiramate( J Subs Abuse Treatment 2008; 34 : 460-463)






Discussion
Discussion

  • All three drugs were well tolerated.

  • Larger studies across diverse populations of patients are needed to replicate and strengthen these results.

  • Family support in India is strong – exploiting this resource is a must in the successful use of Disulfiram.


Other studies done by us
Other studies done by us

  • Disulfiram superior to Naltrexone in elderly alcoholics.

    (Journal of Pakistan Psychiatric Society 2009)

  • Disulfiram superior to Naltrexone in adolescent alcohol dependence patients.

    (Journal of Substance Use 2006)

  • Disulfiramsuperior to Naltrexone in female alcoholics.

    (unpublished work)


Studies in progress
Studies in progress

  • Disulfiram versus a Combined Naltrexone and Acamprosate regime

  • Does Acamprosate addition enhance Disulfiram therapy.

  • Disulfiram and Psychotherapy.

    (All studies would be complete by 2011-2012)


Other pivotal studies
Other pivotal studies

  • The Helsinki Disulfiram study.

  • Disulfiram superior to Acamprosate.

  • OLITA Study.

  • Other small but important studies.


Limitations
Limitations

  • Open studies rather than a blinded ones. Hypothetically a bias may have been introduced.

  • No laboratory marker used to assess compliance.

  • Good primary support group leading to fewer drop outs.

  • Stringent inclusion criteria.


Other issues in disulfiram therapy
Other issues in Disulfiram therapy

  • Incorporating Disulfiram into psychotherapy.

  • Disulfiram in patients with comorbid psychiatric disorders.

  • Where does Disulfiram stand today in the modern pharmacotherapy of alcoholism.


Conclusions
Conclusions

  • Disulfiram is a treatment option that cannot be ignored.

  • Psychiatrists worldwide need to be trained.

  • Oral DisulfiramVS Long acting Naltrexone or Naltrexone implants

  • Effective compliance monitoring.


Acknowledgements
Acknowledgements

  • The Stapleford Conference and its organizers.

  • My parents who have taught me most of my psychiatry.

  • My country that gives me enough freedom and patients who trust me fully.

  • Everyone here who made me feel at home.