Transcript ZIS Heroinstudie

Heroin prescription —
new responses for the hard to
treat
Christian Haasen
University of Hamburg, Germany
Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg ZIS
History
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1972: American Bar Association recommends
heroin assisted treatment (HAT)
1973: Editorial in New England Medical Journal
recommending HAT
1980: publication of first controlled study in
UK on MMT vs. HAT, with some results
favouring MMT, other favouring HAT
1997: publication of Swiss study results
2003: publication of Dutch study results
2006: publication of Andalusian study results
2007: publication of German study results
Swiss Study
Disadvantages according to WHO
evaluation:
– No control group
– Which effects are due to pharmacology
and which are due to psychosocial
intervention?
– No “intention to treat” (ITT) analysis
 HAT now established maintenance
treatment in Switzerland with ~1200
treatment slots
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Dutch Study
Diamorphine as Add-On treatment
 Small sample size for i.v.-treatment, main
sample for inhalable diamorphine
 Effect of pharmacotherapy vs.
psychosocial intervention remains unclear
 Target group: methadone non-responders
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HAT now established maintenance
treatment in the Netherlands
Target groups – German study
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Methadone treatment failures (MTF)
– Opiate addicts presently in methadonemaintenance treatment, who have not
profited sufficiently from treatment
– Around 10% non-response in MMT
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Untreated / not in treatment (NIT)
– Heroin addicts, who have dropped out of
treatment services and are presently not in
treatment, but in need of treatment due to
their state of health or present life situation
– Only up to 50% in treatment
Retention rate
(“treatment-initiated” sample)
Heroin
Methadone
100%
80%
68,1%
56,3%
60%
40%
20%
0%
after 12 months
Higher
total percentage of methadone group returned to illicit drug use
Daily dosage over 365 days
Heroin patients H-dose
Methadone patients M-dose
daily dose in mg
500
400
300
200
100
0
1
31
61
91
121
151
181 211
days
241
271
301
Mean: Heroin: H-dose: 442 mg, Methadone: M-dose: 99 mg
331
361
Response-Definition:
Primary outcome measures (POM)
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Improvement of physical or mental
health
 Response in POM (A)
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Reduction of illicit drug use
 Response in POM (B)
Differences in response rates are tested for significance
Primary analysis (ITT) – Response by POM
Heroin
Methadone
100%
80,0%
74,0%
69,1%
80%
55,2%
60%
40%
20%
0%
POM health
Health: OR = 1.41 * (1.05-1.89),
POM drug use
Drug use: OR = 1.85 *** (1.43-2.40)
Response for treatment completers
(per-protocol analysis)
Heroin
100%
Methadone
87,0%
77,0%
80%
73,1%
51,5%
60%
40%
20%
0%
POM health
POM drug use
Health: OR = 2.05 ** (1.28-3.27), Drug use: OR = 2.64 *** (1.80-3.88)
Response in both POM
Heroin
Methadon
100%
80%
60%
57,3%
44,8%
40%
20%
0%
OR = 1.67 *** (95%-CI: 1.30-2.14); NNT=8
Criminality
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Offences:
– 79% of patients in year prior to treatment
– 45% of heroin, 63% of methadone group
in first year of treatment
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Significant advantage of heroin group in
reduction of criminality, both in number of
days with criminal offences and in number
of offences
Contacts to other persons
using drugs
heroin
methadone
100%
80%
60%
40%
20%
0%
T-1
T6
T12
Health-economic analyses
Similar costs of treatment as Swiss &
Dutch studies
 QALY costs: heroin
155,000 €
methadone
170,000 €
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Physical health complaints
(OTI health scale) N=434
heroin
methadone/heroin
number of symptoms
20
***
15
*
10
5
T-1
T6
phase 1
T12
T18
|
T24
phase 2
Mental health distress
(SCL-90-R, GSI)
heroin
methadone/heroin
Global Severity Index
1,4
1,2
(*)
1
*
0,8
0,6
0,4
T-1
T6
phase 1
T12
T18
|
T24
phase 2
Use of street heroin
in the past 30 days
heroin
methadone/heroin
number of days
25
20
***
15
ns
10
5
0
T-1
T6
phase 1
T12
T18
|
phase 2
T24
Cocaine use past 30 days
heroin
methadone/heroin
number of days
15
***
10
*
5
0
T-1
T6
phase 1
T12
T18
|
phase 2
T24
Currently working
4 year course (N=156)
50%
40%
30%
Cochran-Test: Q=38,8, p<0,001
20%
10%
0%
T-1
T12
T24
Phase 1 | Phase 2 |
T36
T48
Follow-up Phase
ZIS
Drug-related mortality in Germany
since 1984
2500
2000
1500
1000
500
0
'84
'86
'88
'90
'92
'94
year
'96
'98
'00
'02
'04
'06
Present status in Germany
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Around 300 patients still
in follow-up heroin
treatment
Registration status:
positive review, heroin
could be registered if
laws are changed
Blockade by conservative
party in government
(CDU), but chance for
positive vote soon
Present status in Europe
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Swiss + NL: registered normal treatment
GB: registered treatment & clinical trial
Belgium: clinical trial
Spain (Andalusia): compassionate use
after clinical trial; clinical trial (oral
heroin) in Barcelona
Denmark: laws changed in order to
initiate heroin-assisted treatment
Norway, France: political discussions
Thank you!
www.heroinstudie.de