Presentation is loading. Please wait.

Presentation is loading. Please wait.

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

Similar presentations


Presentation on theme: "ORAL SUBSTITUTION WITH BUPRENORPHINE Anju Dhawan Associate Professor National Drug Dependence Treatment Centre AIIMS."— Presentation transcript:

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 : Post-Marketing Surveillance study of buprenorphine Ray 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 Delhi in 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: ?? 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 Coordinating centre NDDTC, AIIMS, New Delhi 5 Participating centres NDDTC, AIIMS, New Delhi SHARAN, New Delhi Calcutta Samaritans, Kolkata SASO, Imphal Presbyterian Hospital, Aizawl UNODC project Oral substitution with Buprenorphine

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

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

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

23 Results: Baseline

24 Description of Sample Age 21 to 40 years 71.4% Males95% Married54% Illiterates25.8% Unemployed38.8% Heroin users88%

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

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

29 Buprenorphine Mean Dosage (in mg) 3 mth Minimum 4.2 ± 1.6 (1-8 mg) Maximum 6.4 ± 2.2 (2-14 mg) Current 5.9 ± 2.4 (1-14 mg) 6 mth 4.4 ± 2.3 ( mg) 5.7 ± 2.3 ( mg) 4.7 ± 2.2 ( mg) 9 mth 3.5 ± 2.7 (0.4 –16 mg) 5.6 ± 2.3 (0.4 –14 mg ) 3.8 ± 2.7 (0.4 –16 mg)

30 NO. OF DAYS ALCOHOL/DRUG USED PAST ONE MONTH (Mean) BASELINE (n=232) 3 mth FU (n=181) 6 mth FU (n= 140 ) 9 mth FU (n= 128) HEROIN 27.8 days/mth 5.3 days/ mth 0.41 days/ mth 2.1 days/ mth ALCOHOL 4.8 days/ mth 3.9 days/ mth 2.25 days/ mth 2.64 days/ mth

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

32 Current Injecting Drug Use (%) Injecting reduced

33 High risk injecting behaviour (%) past one mth BASE LINE 3 mths FU 6 mths FU 9 mths FU No. of times use a needle after someone No sharing 2-10 times

34 High risk sexual behaviour (%) past one mth No Use of Condom BASE LINE 3 mths FU 6 mths FU 9 mths FU Sex with regular partner Sex with casual partner Sex with paid partner

35 Addiction Severity Scores Domains

36 How do the patients rate their Quality of Life

37 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

38 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

39 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

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

41 Contents History and Milestones Our Experience: Clinical and Research The Future

42 UNODC supported oral substitution project: Extension 10 More Participating centres (i.e. total 15 centres) The Future 1.SPYM, Delhi 2.Sahara, Delhi 3.TSSS, Trivandrum 4.TTRCRF, Chennai 5.VJSS, Bhubaneshwar 6.Kripa Foundation, Kohima 7.Galaxy Club, Imphal 8.Bethesda, Dimapur 9.Cal Sam Jamshedpur 10.SEHAT, Chandigarh

43 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

44 T h a n k y o u


Download ppt "ORAL SUBSTITUTION WITH BUPRENORPHINE Anju Dhawan Associate Professor National Drug Dependence Treatment Centre AIIMS."

Similar presentations


Ads by Google