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ORAL SUBSTITUTION WITH BUPRENORPHINE
Anju DhawanAssociate Professor
National Drug Dependence Treatment CentreAIIMS
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Contents
History and MilestonesExperience: Research and Clinical The Future
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Contents
History and MilestonesOur Experience: Clinical and ResearchThe Future
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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
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Maintenance treatment: history and milestones
2000: Launch of higher strength
buprenorphine tablets
2000-2001: Post-Marketing Surveillance
study of buprenorphine Ray
et al, 2004
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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”
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Contents
History and MilestonesExperience: Research and ClinicalThe Future
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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
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Studies on Effectiveness (AIIMS) Methodological Issues
Used buprenorphine in very low doses only Combined psychosocial interventionAssessed outcome in multiple domainsStandard instruments used for assessmentFollow-up- 6 months, 1 year
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Data on Effectiveness (AIIMS)…
Substantial reduction in drug and even alcohol useImprovement in psychological status and subjective well beingReduction in legal problems Reduction in family problems
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Data on Effectiveness from other sources
Increase in treatment utilizationReduction in injecting risk behaviour
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What Did We Learn from Research and Clinical Experience?
OptionsBuprenorphine substitution treatment is:
Feasible Acceptable to clientsEffective Safe
Optimum dose: ?? 4 - 8 mg/dayCombined with psychosocial interventionCan be shifted to Naltrexone
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So Far…
Buprenorphine in India: Buprenorphine still currently available only in very few treatment centersNot available as a treatment option to majority of drug users
Need to scale-up Protocol/Practice guidelines
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INTERVENTION- ORAL SUBSTITUTION WITH
BUPRENORPHINE
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Coordinating centreNDDTC, AIIMS, New Delhi
5 Participating centres NDDTC, AIIMS, New Delhi SHARAN, New DelhiCalcutta Samaritans, KolkataSASO, Imphal Presbyterian Hospital, Aizawl
UNODC project
Oral substitution with BuprenorphineOral substitution with Buprenorphine
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Aim
Documenting effectiveness, and
Finalizing practice guidelines
…to enable wider use.
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Methodology
Recruitment using inclusion & exclusion criteria (45 patients at each centre)
Intervention: pharmacological and psychosocial
Assessment: quantitative, qualitative, biochemical
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Pharmacological Intervention
Flexible dosing regimen Dispensed daily, supervisedDose of 2-12 mg/dayDuration: 6 months, extended now
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Psychosocial Intervention
Two sessions of one hour each in the first six months
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Assessments
At baseline and every 3 months
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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
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Process indicators
Urine screening (in two centres)
Assessment: Qualitative
Assessment: Biochemical
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Results: BaselineResults: Baseline
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Description of Sample
Age 21 to 40 years 71.4%Males 95%Married 54%Illiterates 25.8%Unemployed 38.8%Heroin users 88%
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Results: 3, 6 and 9 MonthsResults: 3, 6 and 9 Months
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Retention rate in the study (%)
78.1
74.8
68.4
60 65 70 75 80
3 mths FU
6mths FU
9 mths FU
Retention
* Data of 6,9 mth FU not received from one centre
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•Due to physical ill health
•Desire to be drug free
•Incarceration/jail
•Relapse
•Inadequate control of craving/withdrawal
REASONS FOR DROP OUT
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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 %
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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
(1.2 -14 mg)
5.7 ± 2.3
(1.6 - 14 mg)
4.7 ± 2.2 (1.2 -14 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)
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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
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Urine Screening Results (AIIMS Site)
1.7
51.3
91.796.4
0
10
2030
40
50
6070
80
90
100
Baseline 3 mths FU 6 mths FU 9 mths FU
Negative
High % of Urine
screening results
negative at 9 mths
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Current Injecting Drug Use (%)
51.3
28.2
22.1
14.9
0
10
20
30
40
50
60
Baseline 3 mths FU 6 mths FU 9 mths FU
Injecting reduced
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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
58.0
36.1
92.2
-
87.1
-
84.2
-
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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
59.0 46.3 36.4 35.9
Sex with casual partner
19.3 16.7 4.5 5.1
Sex with paid partner
15.7 9.3 4.5 2.6
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Addiction Severity Scores
baseline 3 mths 6 mths 9mths
Psycho.
Family Rel.
Legal
Employment
Medical
Alcohol
Drug
Domains
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How do the patients rate their Quality of Life
0
10
20
30
40
50
60
Baseline 3 mths 6 mths 9 mths
Good
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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
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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
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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
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Shifting to Buprenorphine-naloxone-take home
Facilitate tapering of agonist substitution
Assessing effectiveness after tapering of agonist and shifting on Naltrexone
Further Plan
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Contents
History and MilestonesOur Experience: Clinical and ResearchThe Future
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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
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The Future
What are the issues in Scaling-up Substitution? Development of a PolicyLegislative and administrative requirementsProtocol/Practice GuidelinesQuality Assurance Mechanisms
Treatment servicesTraining of staff
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T h a n k y o u