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!

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