Feasibility •Steps involved in initiating services …€¢ Snowballing/by word of mouth/TI...

• 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%


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%


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%


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%


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


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%


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


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

Feasibility •Steps involved in initiating services …€¢ Snowballing/by word of mouth/TI...

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