1. Heroin prescription — new responses for the hard to treat Christian Haasen University of Hamburg, Germany Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg ZIS

2. History 1972: American Bar Association recommends heroin assisted treatment (HAT) 1972: American Bar Association recommends heroin assisted treatment (HAT) 1973: Editorial in New England Medical Journal recommending 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 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 1997: publication of Swiss study results 2003: publication of Dutch study results 2003: publication of Dutch study results 2006: publication of Andalusian study results 2006: publication of Andalusian study results 2007: publication of German study results 2007: publication of German study results

3. Swiss Study Disadvantages according to WHO evaluation: 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 HAT now established maintenance treatment in Switzerland with ~1200 treatment slots

4. Dutch Study Diamorphine as Add-On treatment Diamorphine as Add-On treatment Small sample size for i.v.-treatment, main sample for inhalable diamorphine Small sample size for i.v.-treatment, main sample for inhalable diamorphine Effect of pharmacotherapy vs. psychosocial intervention remains unclear Effect of pharmacotherapy vs. psychosocial intervention remains unclear Target group: methadone non-responders Target group: methadone non-responders HAT now established maintenance treatment in the Netherlands HAT now established maintenance treatment in the Netherlands

5. Target groups – German study Methadone treatment failures (MTF) Methadone treatment failures (MTF) –Opiate addicts presently in methadone- maintenance treatment, who have not profited sufficiently from treatment –Around 10% non-response in MMT Untreated / not in treatment (NIT) 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

7. Retention rate (“treatment-initiated” sample) Higher total percentage of methadone group returned to illicit drug use Higher total percentage of methadone group returned to illicit drug use

8. Daily dosage over 365 days Mean: Heroin: H-dose: 442 mg, Methadone: M-dose: 99 mg

9. Response-Definition: Primary outcome measures (POM) Improvement of physical or mental health  Response in POM (A) Improvement of physical or mental health  Response in POM (A) Reduction of illicit drug use  Response in POM (B) Reduction of illicit drug use  Response in POM (B) Differences in response rates are tested for significance

10. Primary analysis (ITT) – Response by POM Health: OR = 1.41 * (1.05-1.89),Drug use: OR = 1.85 *** (1.43-2.40)

11. Response for treatment completers (per-protocol analysis) Health: OR = 2.05 ** (1.28-3.27), Drug use: OR = 2.64 *** (1.80-3.88)

12. Response in both POM OR = 1.67 *** (95%-CI: 1.30-2.14); NNT=8

13. Criminality Offences: Offences: –79% of patients in year prior to treatment –45% of heroin, 63% of methadone group in first year of treatment Significant advantage of heroin group in reduction of criminality, both in number of days with criminal offences and in number of offences Significant advantage of heroin group in reduction of criminality, both in number of days with criminal offences and in number of offences

14. Contacts to other persons using drugs

15. Health-economic analyses Similar costs of treatment as Swiss & Dutch studies Similar costs of treatment as Swiss & Dutch studies QALY costs: heroin 155,000 € methadone 170,000 € QALY costs: heroin 155,000 € methadone 170,000 €

16. Physical health complaints (OTI health scale) N=434 phase 1phase 2 | *** *

17. Mental health distress (SCL-90-R, GSI) phase 1phase 2 | (*)(*) *

18. Use of street heroin in the past 30 days phase 1phase 2 | *** ns

19. Cocaine use past 30 days phase 1phase 2 | *** *

20. Currently working 4 year course (N=156) ZIS Phase 1Phase 2 || Follow-up Phase Cochran-Test: Q=38,8, p<0,001

21. Drug-related mortality in Germany since 1984 year

22. Present status in Germany Around 300 patients still in follow-up heroin treatment Around 300 patients still in follow-up heroin treatment Registration status: positive review, heroin could be registered if laws are changed 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 Blockade by conservative party in government (CDU), but chance for positive vote soon

23. Present status in Europe Swiss + NL: registered normal treatment Swiss + NL: registered normal treatment GB: registered treatment & clinical trial GB: registered treatment & clinical trial Belgium: clinical trial Belgium: clinical trial Spain (Andalusia): compassionate use after clinical trial; clinical trial (oral heroin) in Barcelona Spain (Andalusia): compassionate use after clinical trial; clinical trial (oral heroin) in Barcelona Denmark: laws changed in order to initiate heroin-assisted treatment Denmark: laws changed in order to initiate heroin-assisted treatment Norway, France: political discussions Norway, France: political discussions

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