ORAL SUBSTITUTION WITH BUPRENORPHINE

Anju DhawanAssociate Professor

National Drug Dependence Treatment CentreAIIMS

Contents

History and MilestonesExperience: Research and Clinical The Future

Contents

History and MilestonesOur Experience: Clinical and ResearchThe 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 MilestonesExperience: Research and ClinicalThe 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 interventionAssessed outcome in multiple domainsStandard instruments used for assessmentFollow-up- 6 months, 1 year

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

Data on Effectiveness from other sources

Increase in treatment utilizationReduction in injecting risk behaviour

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

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

INTERVENTION- ORAL SUBSTITUTION WITH

BUPRENORPHINE

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

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, supervisedDose of 2-12 mg/dayDuration: 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

Process indicators

Urine screening (in two centres)

Assessment: Qualitative

Assessment: Biochemical

Results: BaselineResults: Baseline

Description of Sample

Age 21 to 40 years 71.4%Males 95%Married 54%Illiterates 25.8%Unemployed 38.8%Heroin users 88%

Results: 3, 6 and 9 MonthsResults: 3, 6 and 9 Months

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

•Due to physical ill health

•Desire to be drug free

•Incarceration/jail

•Relapse

•Inadequate control of craving/withdrawal

REASONS FOR DROP OUT

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

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)

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)

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

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

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

-

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

Addiction Severity Scores

baseline 3 mths 6 mths 9mths

Psycho.

Family Rel.

Legal

Employment

Medical

Alcohol

Drug

Domains

How do the patients rate their Quality of Life

0

10

20

30

40

50

60

Baseline 3 mths 6 mths 9 mths

Good

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-Buprenorphine-naloxone 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

Shifting to Buprenorphine-naloxone-take home

Facilitate tapering of agonist substitution

Assessing effectiveness after tapering of agonist and shifting on Naltrexone

Further Plan

Contents

History and MilestonesOur Experience: Clinical and ResearchThe Future

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

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

T h a n k y o u