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
• Steps involved in initiating services
Feasibility
• Quantitative assessments (pre-post)
Effectiveness
� 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
UNODC ROSA
KEM, Mumbai NDDTC, AIIMS RIMS, ImphalCivil
Hospital, Kapurthala
Civil Hospital, Bathin
da
NDDTC AIIMS
• 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
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
BASELINE ASSESSMENT
ASSESSMENT FOR SUITABILITY OF TREATMENT
RECRUITMENT OF PATIENTS
REPEAT OBSERVATION AND ASSESSMENTS
METHADONE MAINTENANCE TREATMENT
Methadone Psychosocial Interventions
BASELINE ASSESSMENT
• 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
� 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
• 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
� 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
RESULTSRESULTS
325 male opioid dependent users from 5 participating centres
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%
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
20.0%
28.0%29.2%
13.2%
Educational status
Illiterate 5 yrs schooling 10 yrs
schooling
Hr. Secondary College
8.9%
13.2%
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%)
40.0%
54.8%
Marital status
Married Never married Married but single
5.2%
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
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%)
91.7%
Living arrangements
With family Alone (streets) Paying guest
1.5%0.3%
• All males
• Age 21 to 40 years - 82%• Age 21 to 40 years - 82%
• Married - 55%
• Illiterates - 9%
• Unemployed - 37%
Baseline assessmentBaseline assessment
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
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
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
InterventionIntervention
� 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%
74%
61%
46%
36%
Retention rate
3 MTH FU 6 MTH FU 9 MTH FU 1 YR FU
36%
� Total no. of days (mean) 382 (155-545 days)
� No. of days taken (median) 242 (6 – 522 days)
� Compliance 73.6 %
Follow-up AssessmentsFollow-up Assessments
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
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
� 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
.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
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%
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
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
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
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)
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
� 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
� 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
� 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
MMT - LearningMMT - Learning
• 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
• 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
• 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
• 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
• 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
• 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
Experience of a patient Experience of a patient
from AIIMS , Delhi
MMT Centre
• 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
• 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
THANK YOU
� 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