Clinical guidance regarding the use of buprenorphine for

Report
There’s a RIOTT going on …
Injecting in the
Randomised Injectable Opioid Treatment Trial
National Addiction Centre
The Alliance
Overview
•
Background & research design: Nicky Metrebian
•
•
Client perspectives: Chris Hallam
Overview of treatment procedures: Nick Lintzeris
•
Injecting in the RIOTT: Rob van der Waal
•
Discussion …
2
Background & research design
Background
• Some opioid dependent injecting drug users appear unable
to make much progress with oral methadone treatment
• Lack of consensus on how to treat these drug users
– Try to make current treatment work better
– Try ‘new approaches’
• Government called for heroin prescribing to be expanded
“all those with a clinical need for heroin prescribing will
have access to it under medical provision safeguarding
against the risk of seepage into the wider community”
(Updated Drug Strategy 2002)
• Little research evidence of its effectiveness
4
Research question
To examine whether providing injectable
opioid treatment for individuals not responding
to their current oral methadone treatment will
result in greater reductions in illicit heroin use
than if providing optimised oral methadone
treatment
…and whether the additional cost of providing
injectable opioids is offset by the additional
benefits of providing it
5
Trial Design
n=50
Injectable
Methadone Group
+/- oral methadone
3 months
6 months
Between group comparisons
Subjects
N=150
n=50
Control Group:
Optimised oral
methadone
Between group comparisons
n=50
Injectable Heroin
Group
+/- oral methadone
6
Eligibility criteria
• Age 18 years or over
• > 3 year history of injecting heroin use
• Currently in methadone treatment (continuous > 6 month)
• Regular injecting heroin use – defined as in past 3 months
– opiate (+)ve UDS; evidence regular injecting on clinical exam
– use of heroin on at least 50% of days in past month (self-report)
• Not pregnant; no active significant medical or psychiatric condition
• Not currently alcohol dependent or unstable benzodiazepine use.
• Able and willing to participate in the study procedures
7
Outcome measures
Outcome
Measures
Drug use
UDS & self-report
Treatment retention
Clinic records (& self report)
Injecting practices
Frequency, risk & complications
Psychosocial functioning &
Quality of Life Measures
SF-36, EQ-5D, OTI
Crime
Self-report (drug related expenditure &
criminal activity)
Cost effectiveness
Service costs (internal & external)
Community Impact Evaluation
‘Nuisance’ issues for local community
8
Client perspectives
• Qualitative & quantitative methods
• At baseline: client perspectives about:
– Benefits and problems of using heroin
– What is going well / not going well at the moment
– What they want from treatment (UNO)
• During treatment: client perspectives about:
– Injecting in the clinics
– Satisfaction with & impact of treatment
– Other issues as they arise
9
Clinical and injecting issues
Treatment procedures:
Optimised Oral Methadone
• Adequate doses (e.g. >100 mg methadone: 300mg max)
• Supervised dispensing 5 days a week for first 3 months
– can be reduced to three times a week thereafter
•
•
•
•
Intensive key work (weekly) & medical (monthly) reviews
Access to psychosocial services (+ psychology, groups)
Treatment of co-morbidity as required (care plans)
Weekly UDS (research related)
• Not mandatory, but subsequent post-trial access to IOT
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requires 6 months ‘optimised’ treatment: NTA Guidance
Treatment Procedures:
Injectable Heroin
• Adequate doses of injectable heroin
– Up to 900 mg / day (up to 450mg / injection)
• Supervision of all doses in 1 – 2 injections per day
• Clients can access oral methadone either on regular basis,
or if unable to attend MH for injected heroin
• + ancillary services as per oral methadone group
12
Induction into heroin group
Preconversion
Oral
Methadone
Dose (mg)
Post-conversion
Total Daily Doses (mg)
Post-conversion Daily
Medication Regimes (mg)
Methadone
(oral)
Heroin
(injected)
Morning
Afternoon
50
15
110
55mg H
55mg H
15mg M
60
20
120
60mg H
60mg H
20mg M
70
25
140
70mg H
70mg H
25mg M
80
25
160
80mg H
80mg H
25mg M
90
30
170
85mg H
85mg H
30mg M
100
35
190
95mg H
95mg H 13
35mg M
Example of dose flexibility
• Option A
• Option B
• Option C
Heroin 150mg IV morning
Heroin 200mg IV afternoon
Methadone oral 30mg
or
Heroin 200mg IV / day
Methadone oral 80mg
or
Methadone oral 140mg
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Treatment Procedures:
Injectable Methadone
• Adequate doses of injectable methadone
– up to 200 mg / day injected (+ up to 100mg oral)
• Supervision of all doses in 1 – 2 injections per day
• Dose conversion: injected dose = 0.8 x oral dose
– then titrate (upwards)
• Clients can access oral methadone either on regular basis,
or if unable to attend clinic for injected methadone
• + ancillary services as per oral methadone group
16
Supervised injecting
• Clinic Hours: 7 days a week
– Mon – Fri: 9 – 11AM; 3 to 5PM
– Weekends; public holidays: 9-11AM – 2-4 PM
• Clients inject themselves under supervision
• Client choice in injecting equipment
• Injecting Room has capacity for 4 people at a time
17
Injecting procedures
• Clients in reception area until called into injecting room
• Pre-dose observation (to exclude intoxication etc)
• On entry into injecting room
– Wash hands
– Given personal container with injecting equipment and
pre-drawn syringe containing methadone / heroin
– Client inject themselves under supervision of 2 nurses
– Clients have 20 minutes in which to inject
– Clients responsible for cleaning up booth & disposing of
used equipment
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19
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Injecting sites
• Injecting sites part of risk assessment
– preference for superficial veins, not deep veins
– clients must be assessed by MO to authorise deep
vein injecting (e.g. groin)
– no injecting into veins with evidence of active / recent
inflammation (infections / thrombosis)
– limits re: genital / breast / neck injecting
– injecting technique important
21
Groin injecting
Consider if …
• no other veins available & not satisfied with IM
injecting
• client has history of groin injecting
• no evidence of current inflammation
• no recent problems (e.g. DVT, infection)
• good groin injecting technique
• aim to limit frequency of groin injecting
22
Things that can go wrong …
• Missed the vein …
• Emergency procedures for
– Overdose
– Anaphylactic shock
– Seizures
– Arterial injection
23
Superficial vein injecting
Unsuccessful after 3
attempts
No blood in
syringe
Intramuscular dose
Blood in syringe
Oral methadone
replacement dose
24
Monitoring
• Formal monitoring occurs during dose induction,
after dose increase, or if there are concerns
• Monitor:
– Pulse rate, blood pressure, respiratory rate, pupil size
– Blood oxygen levels (pulse oxymeter)
– Client and staff rating of withdrawal; sedation
• Monitored before injection, and 5, 15 & 30
minutes after injection.
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pO2 Post-Injection
96
IM
IV
95
%
94
93
92
91
0
10
20
30
40
50
60
Minutes post-injection
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Funding
• Trial co-ordinated by the National Addiction
Centre, Institute of Psychiatry, KCL
• Research Funding
– Big Lottery & Action on Addiction
• Clinical Services Funding
– National Treatment Agency
– Local DATs & PCTs
– Big Lottery & Action on Addiction
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