Feasibility •Steps involved in initiating services …€¢ Snowballing/by word of mouth/TI...
Transcript of Feasibility •Steps involved in initiating services …€¢ Snowballing/by word of mouth/TI...
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• Steps involved in initiating services
Feasibility
• Quantitative assessments (pre-post)
Effectiveness
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• Steps involved in initiating services
Feasibility
• Quantitative assessments (pre-post)
Effectiveness
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� Effectiveness well-established
� Over 100 randomized studies from different countries – USA,
Australia, Europe, Asia (Iran, China, Thailand)
� Joint position paper by WHO/UNODC/UNAIDS� Joint position paper by WHO/UNODC/UNAIDS
� Indian data on how it works in our
patients and our settings is still required
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UNODC ROSA
KEM, Mumbai NDDTC, AIIMS RIMS, ImphalCivil
Hospital, Kapurthala
Civil Hospital, Bathin
da
NDDTC AIIMS
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• Ethical clearance from the ethics committees
(AIIMS, KEM, RIMS) and permission from Secretary (AIIMS, KEM, RIMS) and permission from Secretary
Health Punjab
• HMSC clearance obtained
• Informed consent taken from the respondents
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Inclusion criteria
� Any gender � Age >18 years � Diagnosis of opioid
dependence � Current IDU� Patients with evidence of
poor compliance/response to
Exclusion criteria
� Serious medical conditions
� Current dependence on alcohol and/or benzodiazepines/any other drug (except tobacco)
� Unwilling to comply with the poor compliance/response to treatment on Buprenrophine*
� Willing for MMT and to provide informed consent
*Poor compliance to buprenorphine measured by missing medication more than 15 days per month or use of illicit drug more than 7 days per month on 8mg/day
� Unwilling to comply with the treatment
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BASELINE ASSESSMENT
ASSESSMENT FOR SUITABILITY OF TREATMENT
RECRUITMENT OF PATIENTS
REPEAT OBSERVATION AND ASSESSMENTS
METHADONE MAINTENANCE TREATMENT
Methadone Psychosocial Interventions
BASELINE ASSESSMENT
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• Methadone orally (in syrup form)
• Induction - 15-20mg/day (30mg in Imphal) followed
by increase of 5mg every 3-4 days till the optimum by increase of 5mg every 3-4 days till the optimum
dose is reached
• DOT (7 days a week): including Sundays
• Adjuvant medications for sleep
• Drug interactions were taken into consideration
• Psychosocial intervention was provided
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� Severity of addiction- Addiction Severity Index
� High risk behaviour- High Risk Behaviour Scale
� Quality of Life- WHO QOL BREF Scale� Quality of Life- WHO QOL BREF Scale
� Withdrawals- SOWS, OOWS
� Side effects- Side effects checklist
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• Subjective and Objective opiate withdrawal scale
• Side effect check list
• Urine screening for recent drug use
• Clinical Assessments every 2 weeks for inital 2
months and at 3 months, 6months, 9 months and 12
months
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� Addiction Severity Index
� WHO Quality of Life BREF scale
� High Risk Behaviour Scale � High Risk Behaviour Scale
� At baseline, 3 months, 6 months, 9 months and 12
months
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RESULTSRESULTS
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325 male opioid dependent users from 5 participating centres
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Upto 20 yrs
8%
21-30 yrs
52%
31-40 yrs
30%
41-50 yrs
10%
Age
Mean age – 30 years (range 18-60 years)
52%
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Upto 20 yrs8%
21-30 yrs52%
31-40 yrs30%
41-50 yrs10%
Mean Age
Delhi - 26 years
Kapurthala - 27 years
Bathinda - 29 years
Mumbai - 34 years 52%Mumbai - 34 years
Imphal - 35 years
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20.0%
28.0%29.2%
13.2%
Educational status
Illiterate 5 yrs schooling 10 yrs
schooling
Hr. Secondary College
8.9%
13.2%
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20.0%
28.0%29.2%
13.2%
Educational status
Delhi - Illiterates/ upto 5 yrs (89%)
Kapurthala - 10-12 yrs of schooling (81%)
Bathinda - 10-12 yrs of schooling (63%)
Imphal - High school/ college (79%)
Illiterate 5 yrs schooling 10 yrs
schooling
Hr. Secondary College
8.9%
13.2%
Imphal - High school/ college (79%)
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40.0%
54.8%
Marital status
Married Never married Married but single
5.2%
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36.3%
13.8%
37.2%
Current employment status
Professional, Administrative /Clerical Work, Business/Self Employed, Transport Worker, Skilled Worker, Unskilled Worker/Labourer, Farmer
Employed (fulltime)
Employed (part time)
Unemployed
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36.3%
13.8%
37.2%
Current employment status
Imphal - Part-time/ Unemployed (35% each)
Employed (fulltime)
Employed (part time)
Unemployed
Mumbai, Delhi - Unemployed - (73%; 76%)
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91.7%
Living arrangements
With family Alone (streets) Paying guest
1.5%0.3%
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• All males
• Age 21 to 40 years - 82%• Age 21 to 40 years - 82%
• Married - 55%
• Illiterates - 9%
• Unemployed - 37%
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Baseline assessmentBaseline assessment
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75.8%
51.3% 51.9%49.6%
Opioid –non injecting use
Heroin Opium Other opioids
14.6%
22.9%
Lifetime use Past month use
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50.0%54.2%
45.0%47.5%
Injecting use
Inj. Heroin Inj. Buprenorphine
Inj. Pentazocine Inj. Propoxyphene
12.1% 13.3%
3.3%0.8%
Lifetime use Past month use
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93.3%
70.0%
57.5%
34.2%
87.1%
35.0%37.5%
Other Drugs used
Tobacco Alcohol Cannabis Oral Pharm.
Sed.
Inhalants
34.2%
16.3%
35.0%
27.1%
1.3%
Lifetime use Past month use
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InterventionIntervention
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� Kapurthala 41 mg (15-65)
� Bathinda 44 mg (10-92)
� Delhi 44 mg (15-110) � Delhi 44 mg (15-110)
� Mumbai 48 mg (20-125)
� Imphal 52 mg (20-125)
• Dose ≥ 40mg - 63%
• Dose ≥ 60mg - 17.5%
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74%
61%
46%
36%
Retention rate
3 MTH FU 6 MTH FU 9 MTH FU 1 YR FU
36%
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� Total no. of days (mean) 382 (155-545 days)
� No. of days taken (median) 242 (6 – 522 days)
� Compliance 73.6 %
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Follow-up AssessmentsFollow-up Assessments
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40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
81.6% 78.3%74.8% 75.3%
Heroin
Heroin
.0%
10.0%
20.0%
30.0%
40.0%
3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR FU
No use 1-7 days 8-14 days 15-21 days 22-30 days
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50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
75.7%
90.5% 91.5% 92.6%
Other Opioids
.0%
10.0%
20.0%
30.0%
40.0%
3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR FU
No use 1-7 days 8-14 days 15-21 days 22-30 days
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� Urine screening done at 2 weeks interval for first two
months and at 3, 6, 9 and 12 months
� 70-80% sample tested negative at all points in time from � 70-80% sample tested negative at all points in time from
4 weeks onwards
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.70
.80
.90
1.00
Addiction Severity Index domain scores
Medical
Employment
.00
.10
.20
.30
.40
.50
.60
BASELINE 3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR FU
Scores
Alcohol
Drug use
Legal
Family
Psychological
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60.0%
70.0%
80.0%
90.0%
100.0%
Any injection use (last one month)
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR FU
7.4% 3.8% 4.4% 5.1%
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BASELINE 3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR
31.7%
4.7% 5.1%1.7% 0
Sharing - someone used a needle after me
Sharing - Used a needle after BASELINE 3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR
FU
BASELINE 3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR FU
17.5%
0.5% 1.3%0 0
Sharing - Used a needle after someone
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40.0%
50.0%
60.0%
70.0%
80.0%
Overall quality of life
0.0%
10.0%
20.0%
30.0%
40.0%
BASELINE 3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR FU
Very poor/poor Neither poor nor good Very good/good
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40.00
50.00
60.00
70.00
80.00
Domain score
WHO Quality of life domain scores
.00
10.00
20.00
30.00
40.00
BASELINE 3 MTH FU 6 MTH FU 9 MTH FU ONE YEAR FU
Domain score
Physical Psychological Social Relationship Environment
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8.2%7.1%
6.0%
3.5% 3.4%
Subjective Opiate withdrawal score
2 wk 4 wks 6 wks 8 wks 3 mth FU
6 mth FU
9 mth FU
1 yr FU
3.5% 3.4%
1.6% 1.4%1.9%1.6%
1.0% 0.7% 0.4% 0.4% 0.0% 0.0% 0.0%
Moderate(17-32) Severe(33-48)
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7
9
11
13
Objective Opiate Withdrawal Score (Median)
-1
1
3
5
2 wks 4 wks 6 wks 8 wks 3 mth 6 mth 9 mth 1 yr
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� Generalized weakness, muscle
aches, craving, constipation, anxiety, sadness, lacriaches, craving, constipation, anxiety, sadness, lacri
mation, sleeplessness, headache, dry
mouth, itching, others
� No serious adverse events/overdose
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� Study carried out in different regions of the country and in
different settings
� Opioid used differed across the settings
� Opioid dependent individuals included in the study from � Opioid dependent individuals included in the study from
different socio-economic backgrounds
� Dose of Methadone across the settings was 40-50mg average
dose although there was a wide range in each centre
� Retention/compliance high
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� Methadone treatment was effective in
� Reducing drug use as confirmed by urine screening
� Reducing injecting risk behaviour� Reducing injecting risk behaviour
� Reducing severity of addiction in multiple domains
� Improving quality of life in multiple domains
� Improved psychosocial status
� Had minimal side effects
� No major adverse events
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MMT - LearningMMT - Learning
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• Can be provided in different kind of hospital
settings - district hospital/medical colleges
• Infrastructure for initiating services was available
in the hospital and with refurbishment, the
services could be initiated
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• Existing hospital staff -Nodal officer, nurses and
1 contractual staff (Research Assistant)
• Challenges but managed well
Can be managed easily with staff similar to that available • Can be managed easily with staff similar to that available
in existing OST programme (doctor, nurse, counselor, data
entry operator)
• Training
• 5 day training - operational and clinical issues
• 3 day training - refresher
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• Requires licenses for storage and transport
• Authority – Excise/State Drug Controller India
• Cost of 50mg/day methadone is INR 18/- (similar
to Buprenorphine and likely to become cheaper) to Buprenorphine and likely to become cheaper)
• Safekeeping measures easily followed in hospital
settings
• No instance of diversion reported by any centre
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• Snowballing/by word of mouth/TI NGO/outreach
• Help sought by patients in most sites without very • Help sought by patients in most sites without very
intensive efforts at recruitment
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• Easy to dispense
• Retention/compliance good
• Induction initiated at 15-20mg (some 30mg/day)
Withdrawals controlled over 3 days and dose • Withdrawals controlled over 3 days and dose
optimized over 2 weeks
• Dosage lower than used in western setting
• Dosage varied within each setting
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• Reduction in drug use, high risk
behavior, psychosocial stability, quality of life
improvedimproved
• Methadone found to be acceptable by patients and
their family members
• Side effects manageable
• Safety not an issue, no instances of overdose
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Experience of a patient Experience of a patient
from AIIMS , Delhi
MMT Centre
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• MMT offers another option for OST • Feasible to be implemented in India • Usual processes and procedures are required to be
followed in implementation of MMT; additional followed in implementation of MMT; additional requirement of a license
• Patients and their family members find methadone acceptable
• There has been no major adverse events, and overdose can be prevented with due safeguards
• Diversion can be prevented following the usual protocols for safekeeping
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• Continuation of existing MMT centres as part of
service delivery
• Can be done by DDAP /NACO - all located in
government hospitalsgovernment hospitals
• Scale up can be planned by DDAP and NACO
based on this experience and the treatment
guidelines developed
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THANK YOU
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� UNODC (ROSA) for supporting
� Various organizations that provided permissions
� Investigators at NDDTC, AIIMS
� Prof Rajat Ray, Dr. Atul Ambekar, Dr. Ravindra Rao, Prof. Raka
Jain, Ms. Anita Chopra, Mr. Deepak YadavJain, Ms. Anita Chopra, Mr. Deepak Yadav
� Investigators at all participating centres
� KEM hospital-Dr. S. Parkar, Dr. Kranti Kadam, Dr. Shilpa Adrarkar
� RIMS-Dr.RK Lenin, Dr. S. Gojendra
� Civil hospital Kapurthala-Dr. S. Bhola
� Civil hospital Bathinda-Dr. Nidhi Gupta
� All nursing and research staff
� Patients and their family members