drugset / Trial / NCT00268814

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.

Timeline

Start
2002-03
Primary completion
2003-12
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Diacetylmorphine Small molecule 400 mg Intravenous
Subject Diacetylmorphine Small molecule 1000 mg Intravenous
Comparator Methadone Other / unclassified 40 mg Oral
Comparator Methadone Other / unclassified 160 mg Oral
Comparator Methadone Other / unclassified 250 mg Oral

Indications