Heroin prescription — new responses for the hard to treat
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Transcript of Heroin prescription — new responses for the hard to treat
Heroin prescription — Heroin prescription — new responses for the hard to new responses for the hard to
treattreat
Christian HaasenChristian HaasenUniversity of Hamburg, GermanyUniversity of Hamburg, Germany
Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg ZIS
HistoryHistory 1972: American Bar Association recommends 1972: American Bar Association recommends
heroin assisted treatment (HAT)heroin assisted treatment (HAT) 1973: Editorial in 1973: Editorial in New England Medical New England Medical
JournalJournal recommending HAT recommending HAT 1980: publication of first controlled study in 1980: publication of first controlled study in
UK on MMT vs. HAT, with some results UK on MMT vs. HAT, with some results favouring MMT, other favouring HATfavouring MMT, other favouring HAT
1997: publication of Swiss study results1997: publication of Swiss study results 2003: publication of Dutch study results2003: publication of Dutch study results 2006: publication of Andalusian study results2006: publication of Andalusian study results 2007: publication of German study results2007: publication of German study results
Swiss StudySwiss Study Disadvantages according to WHO Disadvantages according to WHO
evaluation:evaluation:– No control groupNo control group– Which effects are due to Which effects are due to
pharmacology and which are due to pharmacology and which are due to psychosocial intervention? psychosocial intervention?
– No “intention to treat” (ITT) analysisNo “intention to treat” (ITT) analysis HAT now established maintenance HAT now established maintenance
treatment in Switzerland with treatment in Switzerland with ~~1200 1200 treatment slotstreatment slots
Dutch StudyDutch Study Diamorphine as Add-On treatmentDiamorphine as Add-On treatment Small sample size for i.v.-treatment, main Small sample size for i.v.-treatment, main
sample for inhalable diamorphinesample for inhalable diamorphine Effect of pharmacotherapy vs. Effect of pharmacotherapy vs.
psychosocial intervention remains psychosocial intervention remains unclearunclear
Target group: methadone non-respondersTarget group: methadone non-responders
HAT now established maintenance HAT now established maintenance treatment in the Netherlandstreatment in the Netherlands
Target groups – German Target groups – German studystudy
Methadone treatment failures (MTF)Methadone treatment failures (MTF)– Opiate addicts presently in methadone-Opiate addicts presently in methadone-
maintenance treatment, who have not maintenance treatment, who have not profited sufficiently from treatmentprofited sufficiently from treatment
– Around 10% non-response in MMTAround 10% non-response in MMT Untreated / not in treatment (NIT)Untreated / not in treatment (NIT)
– Heroin addicts, who have dropped out of Heroin addicts, who have dropped out of treatment services and are presently not treatment services and are presently not in treatment, but in need of treatment in treatment, but in need of treatment due to their state of health or present life due to their state of health or present life situationsituation
– Only up to 50% in treatmentOnly up to 50% in treatment
Retention rate Retention rate (“treatment-initiated” sample)(“treatment-initiated” sample)
68,1%
56,3%
0%
20%
40%
60%
80%
100%
after 12 months
Heroin Methadone
Higher total percentage of methadone group returned to illicit drug useHigher total percentage of methadone group returned to illicit drug use
Daily dosage over 365 daysDaily dosage over 365 days
0
100
200
300
400
500
1 31 61 91 121 151 181 211 241 271 301 331 361days
daily
dos
e in
mg
Heroin patients H-dose Methadone patients M-dose
Mean: Heroin: H-dose: 442 mg, Methadone: M-dose: 99 mg
Response-Definition:Response-Definition: Primary outcome measures Primary outcome measures
(POM)(POM) Improvement of physical or Improvement of physical or
mental health mental health
Response in POM (A) Response in POM (A)
Reduction of illicit drug use Reduction of illicit drug use
Response in POM (B) Response in POM (B)Differences in response rates are tested for significance
Primary analysis (ITT) – Response by POMPrimary analysis (ITT) – Response by POM
80,0%74,0%
69,1%
55,2%
0%
20%
40%
60%
80%
100%
POM health POM drug use
Heroin Methadone
Health: OR = 1.41 * (1.05-1.89), Drug use: OR = 1.85 *** (1.43-2.40)
Response for treatment completers Response for treatment completers (per-protocol analysis)(per-protocol analysis)
87,0%77,0% 73,1%
51,5%
0%
20%
40%
60%
80%
100%
POM health POM drug use
Heroin Methadone
Health: OR = 2.05 ** (1.28-3.27), Drug use: OR = 2.64 *** (1.80-3.88)
Response in Response in bothboth POM POM
57,3%
44,8%
0%
20%
40%
60%
80%
100%
Heroin Methadon
OR = 1.67 *** (95%-CI: 1.30-2.14); NNT=8
CriminalityCriminality Offences: Offences:
– 79% of patients in year prior to treatment 79% of patients in year prior to treatment – 45% of heroin, 63% of methadone group 45% of heroin, 63% of methadone group
in first year of treatmentin first year of treatment Significant advantage of heroin group Significant advantage of heroin group
in reduction of criminality, both in in reduction of criminality, both in number of days with criminal offences number of days with criminal offences and in number of offencesand in number of offences
Contacts to other persons Contacts to other persons using drugsusing drugs
0%
20%
40%
60%
80%
100%
T-1 T6 T12
heroin methadone
Health-economic analysesHealth-economic analyses Similar costs of treatment as Swiss & Similar costs of treatment as Swiss &
Dutch studiesDutch studies QALY costs: QALY costs: heroin heroin 155,000 € 155,000 €
methadone methadone 170,000 €170,000 €
5
10
15
20
T-1 T6 T12 T18 T24
num
ber o
f sym
ptom
s
heroin methadone/heroin
Physical health complaintsPhysical health complaints(OTI health scale) N=434(OTI health scale) N=434
phase 1 phase 2|
***
*
Mental health distressMental health distress(SCL-90-R, GSI)(SCL-90-R, GSI)
0,4
0,6
0,8
1
1,2
1,4
T-1 T6 T12 T18 T24
Glo
bal S
ever
ity In
dex
heroin methadone/heroin
phase 1 phase 2|
(*)
*
Use of street heroinUse of street heroinin the past 30 daysin the past 30 days
0
5
10
15
20
25
T-1 T6 T12 T18 T24
num
ber o
f day
s
heroin methadone/heroin
phase 1 phase 2|
***ns
Cocaine use past 30 daysCocaine use past 30 days
0
5
10
15
T-1 T6 T12 T18 T24
num
ber o
f day
s
heroin methadone/heroin
phase 1 phase 2|
***
*
0%
10%
20%
30%
40%
50%
T-1 T12 T24 T36 T48
Currently workingCurrently working4 year course 4 year course (N=156)(N=156)
ZISPhase 1 Phase 2| | Follow-up Phase
Cochran-Test: Q=38,8, p<0,001
Drug-related mortality in Germany since 1984
0
500
1000
1500
2000
2500
'84 '86 '88 '90 '92 '94 '96 '98 '00 '02 '04 '06
year
Present status in GermanyPresent status in Germany Around 300 patients Around 300 patients
still in follow-up heroin still in follow-up heroin treatmenttreatment
Registration status: Registration status: positive review, heroin positive review, heroin could be registered if could be registered if laws are changedlaws are changed
Blockade by Blockade by conservative party in conservative party in government (CDU), but government (CDU), but chance for positive vote chance for positive vote soonsoon
Present status in EuropePresent status in Europe Swiss + NL: registered normal Swiss + NL: registered normal
treatmenttreatment GB: registered treatment & clinical trialGB: registered treatment & clinical trial Belgium: clinical trialBelgium: clinical trial Spain (Andalusia): compassionate use Spain (Andalusia): compassionate use
after clinical trial; clinical trial (oral after clinical trial; clinical trial (oral heroin) in Barcelonaheroin) in Barcelona
Denmark: laws changed in order to Denmark: laws changed in order to initiate heroin-assisted treatmentinitiate heroin-assisted treatment
Norway, France: political discussionsNorway, France: political discussions
Thank you!Thank you!
www.heroinstudie.dewww.heroinstudie.de