The German model project for heroin assisted treatment of opiate dependent patients - A multi-centre, randomised, controlled treatment study. Clinical study report of the first study phase

ENGLISH :
The German project of heroin assisted treatment of opiate dependent patients addresses drug addicts who were not successfully treated by the existing addiction therapies or whose course of methadone maintenance treatment was not satisfactory; these patients will receive injectable heroin as medication on a trial basis; a parallel control group will receive the substitution drug methadone. Both groups will be in medical care on a regular basis and receive additional psychosocial treatment. The therapy study, which will evaluate the efficacy of heroin assisted treatment, is carried out as a clinically controlled comparison study according to the guidelines of Good Clinical Practice (GCP) and the regulations of the drugs act (Arzneimittelgesetz, AMG) and the narcotics act (Betäubungsmittelgesetz, BtMG). The treatment extends over a period of 24 months. The design is conceived to assess the therapeutic value and efficacy of heroin treatment in defined target groups in comparison to the established alternative treatment, i.e. methadone maintenance treatment. The study will be conducted in an integrated treatment setting, i.e. a combined treatment consisting of pharmaco/medical intervention and additional psychosocial treatment. The study design is the result of a thorough analysis of previous knowledge and research on opiate assisted treatment, of the requirements set down in the invitation for proposals of the German Ministry of Health, the critical comments by experts concerning the submitted proposal and the additional comments of the participating centres resulting from many discussions. The adopted interdisciplinary approach fulfils the requirements of the invitation for proposals with regard to a clinical pharmacological trial (in a stricter sense) and additional issues of treatment and care research. In simplified terms, the treatment study has the following three basic tasks: - a clinical pharmacological trial to test the efficacy of heroin assisted treatment in comparison with methadone treatment, - an examination of potential indication criteria for heroin assisted treatment (which groups of heroin dependent patients profit most?) and - an investigation of feasibility and efficacy of the various medical and psychosocial treatment elements. (Editor' s abstract)