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ORAL SUBSTITUTION WITH BUPRENORPHINE Anju Dhawan Associate Professor

ORAL SUBSTITUTION WITH BUPRENORPHINE Anju Dhawan Associate Professor National Drug Dependence Treatment Centre AIIMS. Contents. History and Milestones Experience: Research and Clinical The Future. Contents. History and Milestones Our Experience: Clinical and Research The Future.

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ORAL SUBSTITUTION WITH BUPRENORPHINE Anju Dhawan Associate Professor

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  1. ORAL SUBSTITUTION WITH BUPRENORPHINE Anju Dhawan Associate Professor National Drug Dependence Treatment Centre AIIMS

  2. Contents • History and Milestones • Experience: Research and Clinical • The Future

  3. Contents • History and Milestones • Our Experience: Clinical and Research • The Future

  4. Maintenance treatment: history and milestones • 1993 onwards: Data on effectiveness from various sources • 1996, 1997: National meetings (MOH) • opiate maintenance as a treatment approach • model of Buprenorphine maintenance should be replicated in more centres • selection criteria

  5. Maintenance treatment: history and milestones • 2000: Launch of higher strength buprenorphine tablets • 2000-2001: Post-Marketing Surveillance study of buprenorphineRay et al, 2004

  6. Maintenance treatment: history and milestones • 2004: A Buprenorphine Maintenance protocol developed by UNODC • 2005: UNODC supported multi-site study on Oral Buprenorphine Substitution initiated • 2006: Launch of Buprenorphine-Naloxone combination tablets – “Take home dispensing”

  7. Contents • History and Milestones • Experience: Research and Clinical • The Future

  8. Data on Effectiveness • Community Based Treatment of Heroin Dependence in Delhiin 1993 (AIIMS) • Five city Buprenorphine substitution programme by 7 NGOs in 1999 (SHARAN) • Community Based Treatment of Heroin Dependence- Nagaland in 2001 (AIIMS) • Data from other organizations

  9. Studies on Effectiveness (AIIMS) Methodological Issues • Used buprenorphine in very low doses only • Combined psychosocial intervention • Assessed outcome in multiple domains • Standard instruments used for assessment • Follow-up- 6 months, 1 year

  10. Data on Effectiveness (AIIMS)… • Substantial reduction in drug and even alcohol use • Improvement in psychological status and subjective well being • Reduction in legal problems • Reduction in family problems

  11. Data on Effectiveness from other sources • Increase in treatment utilization • Reduction in injecting risk behaviour

  12. What Did We Learn from Research and Clinical Experience? • Options • Buprenorphine substitution treatment is: • Feasible • Acceptable to clients • Effective • Safe • Optimum dose: ?? 4 - 8 mg/day • Combined with psychosocial intervention • Can be shifted to Naltrexone

  13. So Far… • Buprenorphine in India: • Buprenorphine still currently available only in very few treatment centers • Not available as a treatment option to majority of drug users • Need to scale-up • Protocol/Practice guidelines

  14. INTERVENTION- ORAL SUBSTITUTION WITH BUPRENORPHINE

  15. UNODC project Oral substitution with Buprenorphine • Coordinating centre • NDDTC, AIIMS, New Delhi • 5 Participating centres • NDDTC, AIIMS, New Delhi • SHARAN, New Delhi • Calcutta Samaritans, Kolkata • SASO, Imphal • Presbyterian Hospital, Aizawl

  16. Aim • Documenting effectiveness, and • Finalizing practice guidelines …to enable wider use.

  17. Intervention: pharmacological and psychosocial Assessment: quantitative, qualitative, biochemical Methodology Recruitment using inclusion & exclusion criteria (45 patients at each centre)

  18. Pharmacological Intervention • Flexible dosing regimen • Dispensed daily, supervised • Dose of 2-12 mg/day • Duration: 6 months, extended now

  19. Psychosocial Intervention • Two sessions of one hour each in the first six months

  20. Assessments • At baseline and every 3 months

  21. Assessment: Quantitative • Demographic details • Drug Use • Motivation • Severity of addiction • Injecting and Sexual Risk Behaviour • Quality of Life • Compliance • Side Effect checklist • Reasons for drop-out

  22. Assessment: Qualitative • Process indicators • Urine screening (in two centres) Assessment: Biochemical

  23. Results: Baseline

  24. Description of Sample • Age 21 to 40 years 71.4% • Males 95% • Married 54% • Illiterates 25.8% • Unemployed 38.8% • Heroin users 88%

  25. Results: 3, 6 and 9 Months

  26. Retention rate in the study (%) * Data of 6,9 mth FU not received from one centre

  27. REASONS FOR DROP OUT • Due to physical ill health • Desire to be drug free • Incarceration/jail • Relapse • Inadequate control of craving/withdrawal

  28. Buprenorphine Compliance Amongst those retained at 9 months • No. of visits to be made = 270 days • No. of visits made = Mean 207.78 ± 64.8 days • Compliance in those retained 76.7 %

  29. Buprenorphine Mean Dosage (in mg)

  30. NO. OF DAYS ALCOHOL/DRUG USED PAST ONE MONTH (Mean)

  31. Urine Screening Results (AIIMS Site) • High % of Urine screening results negative at 9 mths

  32. Current Injecting Drug Use (%) • Injecting reduced

  33. Addiction Severity Scores Domains

  34. How do the patients rate their Quality of Life

  35. Qualitative findings • Enhancement of staff skills was possible • Attitude of staff: positive • Recruitment of patients - Methods • Patients satisfaction with treatment • Buprenorphine: safe-keeping and diversion not a problem

  36. Lessons Learnt • Variable duration of substitution required • Dropouts need intensive follow-up • Requests for take home medicine-Buprenorphine-naloxone may be given after initial few months • Need for more intensive and sustained psychosocial intervention

  37. Implications • Possible to implement Buprenorphine Maintenance by imparting adequate training • Documented effectiveness • Lessons Learnt to go into finalizing Protocol/Practice Guidelines • Scale-up should be possible with the help of training and Protocol/practice guidelines

  38. Further Plan • Shifting to Buprenorphine-naloxone-take home • Facilitate tapering of agonist substitution • Assessing effectiveness after tapering of agonist and shifting on Naltrexone

  39. Contents • History and Milestones • Our Experience: Clinical and Research • The Future

  40. The Future • UNODC supported oral substitution project: Extension • 10 More Participating centres (i.e. total 15 centres) • SPYM, Delhi • Sahara, Delhi • TSSS, Trivandrum • TTRCRF, Chennai • VJSS, Bhubaneshwar • Kripa Foundation, Kohima • Galaxy Club, Imphal • Bethesda, Dimapur • Cal Sam Jamshedpur • SEHAT, Chandigarh

  41. The Future What are the issues in Scaling-up Substitution? • Development of a Policy • Legislative and administrative requirements • Protocol/Practice Guidelines • Quality Assurance Mechanisms • Treatment services • Training of staff

  42. T h a n k y o u

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