The German Project of Heroin Assisted Treatment of Opiate Dependent Patients
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
The study will test the hypotheses that heroin assisted treatment, compared to methadone
maintenance treatment, is more effective with regard to
- the improvement of health,
- reduction of illicit drug consumption,
- decrease of criminal behaviour,
- rise in the accessibility and retainment,
- detachment from a social drug context,
- social stabilisation in the sense of new drug-free contacts, improved vocational
circumstances, financial security, stabilisation of the living situation,
- enrollment in subsequent treatment in the case of heroin dependent persons who could not
be effectively reached or successfully treated so far, and it will check which is the
optimal treatment setting with regard to these aims.
The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d
The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24
months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and
2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to
ICD-10, who are not being treated currently or who are in a methadone maintenance programme
with an unsatisfactory course of treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborators:
City of Bonn City of Cologne City of Frankfurt City of Hamburg City of Hanover City of Munich Federal Ministry of Health, Germany State of Hessen State of Lower-Saxony State of Northrhine-Westfalia