Transcript History and Milestones

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
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
Maintenance treatment:
history and milestones
2000: Launch of higher strength buprenorphine
tablets
2000-2001: Post-Marketing Surveillance study of
buprenorphine
Ray et al, 2004
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”
Contents
History and Milestones
Experience: Research and Clinical
The Future
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
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
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
Data on Effectiveness from
other sources
Increase in treatment utilization
Reduction in injecting risk behaviour
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
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
INTERVENTIONORAL SUBSTITUTION WITH
BUPRENORPHINE
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
Aim
Documenting effectiveness, and
Finalizing practice guidelines
…to enable wider use.
Methodology
Recruitment using inclusion &
exclusion criteria (45 patients at each centre)
Intervention: pharmacological
and psychosocial
Assessment: quantitative, qualitative, biochemical
Pharmacological Intervention
Flexible dosing regimen
Dispensed daily, supervised
Dose of 2-12 mg/day
Duration: 6 months, extended now
Psychosocial Intervention
Two sessions of one hour each in the first
six months
Assessments
At baseline and every 3 months
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
Assessment: Qualitative
Process indicators
Assessment: Biochemical
Urine screening (in two centres)
Results: Baseline
Description of Sample
Age 21 to 40 years
Males
Married
Illiterates
Unemployed
Heroin users
71.4%
95%
54%
25.8%
38.8%
88%
Results: 3, 6 and 9 Months
Retention rate in the study (%)
68.4
9 mths FU
Retention
74.8
6mths FU
78.1
3 mths FU
60
65
70
* Data of 6,9 mth FU not received from one centre
75
80
REASONS FOR DROP OUT
•Due to physical ill health
•Desire to be drug free
•Incarceration/jail
•Relapse
•Inadequate control of craving/withdrawal
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 %
Buprenorphine Mean Dosage
(in mg)
3 mth
6 mth
9 mth
Minimum
4.2 ± 1.6
(1-8 mg)
4.4 ± 2.3
(1.2 -14 mg)
3.5 ± 2.7
(0.4 –16 mg)
Maximum
6.4 ± 2.2
(2-14 mg)
5.7 ± 2.3
(1.6 - 14 mg)
5.6 ± 2.3
(0.4 –14 mg )
Current
5.9 ± 2.4
(1-14 mg)
4.7 ± 2.2
(1.2 -14 mg)
3.8 ± 2.7
(0.4 –16 mg)
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
Urine Screening Results
(AIIMS Site)
High % of
Urine
screening
results
negative at 9
mths
100
90
80
70
60
50
40
30
20
10
0
91.7
96.4
51.3
1.7
Baseline
3 mths FU 6 mths FU 9 mths FU
Negative
Current Injecting Drug Use (%)
60
50
Injecting
reduced
51.3
40
28.2
30
22.1
20
14.9
10
0
Baseline
3 mths FU 6 mths FU 9 mths FU
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
58.0
92.2
87.1
84.2
2-10 times
36.1
-
-
-
High risk sexual behaviour (%)
past one mth
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
No Use of Condom
Addiction Severity Scores
Domains
Psycho.
Family Rel.
Legal
Employment
Medical
Alcohol
Drug
baseline
3 mths
6 mths
9mths
How do the patients rate
their Quality of Life
60
50
40
30
Good
20
10
0
Baseline
3 mths
6 mths
9 mths
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
Lessons Learnt
Variable duration of substitution required
Dropouts need intensive follow-up
Requests for take home medicine-Buprenorphinenaloxone may be given after initial few months
Need for more intensive and sustained
psychosocial intervention
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
Further Plan
Shifting to Buprenorphine-naloxone-take home
Facilitate tapering of agonist substitution
Assessing effectiveness after tapering of agonist and
shifting on Naltrexone
Contents
History and Milestones
Our Experience: Clinical and Research
The Future
The Future
UNODC supported oral substitution project:
Extension
10 More Participating centres (i.e. total 15 centres)
1. SPYM, Delhi
6. Kripa Foundation, Kohima
2. Sahara, Delhi
7. Galaxy Club, Imphal
3. TSSS, Trivandrum
8. Bethesda, Dimapur
4. TTRCRF, Chennai
9. Cal Sam Jamshedpur
5. VJSS, Bhubaneshwar
10. SEHAT, Chandigarh
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
Thank you