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Heroin prescription — new responses for the hard to treat. Christian Haasen University of Hamburg, Germany. Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg ZIS. History. 1972: American Bar Association recommends heroin assisted treatment (HAT)
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Heroin prescription — new responses for the hard to treat Christian Haasen University of Hamburg, Germany Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg ZIS
History • 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
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 • HAT now established maintenance treatment in the Netherlands
Target groups – German study • 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) • 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) • Higher total percentage of methadone group returned to illicit drug use
Daily dosage over 365 days Mean: Heroin: H-dose: 442 mg,Methadone: M-dose: 99 mg
Response-Definition:Primary outcome measures (POM) • Improvement of physical or mental health Response in POM (A) • Reduction of illicit drug use Response in POM (B) Differences in response rates are tested for significance
Primary analysis (ITT) – Response by POM Health: OR = 1.41 * (1.05-1.89), Drug use: OR = 1.85 *** (1.43-2.40)
Response for treatment completers (per-protocol analysis) Health: OR = 2.05 ** (1.28-3.27), Drug use: OR = 2.64 *** (1.80-3.88)
Response in both POM OR = 1.67 *** (95%-CI: 1.30-2.14); NNT=8
Criminality • 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
Health-economic analyses • Similar costs of treatment as Swiss & Dutch studies • QALY costs: heroin 155,000 € methadone 170,000 €
*** * Physical health complaints(OTI health scale) N=434 | phase 1 phase 2
(*) * Mental health distress(SCL-90-R, GSI) | phase 1 phase 2
*** ns Use of street heroinin the past 30 days | phase 1 phase 2
*** * Cocaine use past 30 days | phase 1 phase 2
Currently working4 year course (N=156) Cochran-Test: Q=38,8, p<0,001 | | Phase 1 Phase 2 Follow-up Phase ZIS
Present status in Germany • 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 • 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