The German Project of Heroin Assisted Treatment of Opiate Dependent Patients

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.

Conditions

• Opioid Dependence

Interventions

DRUG

Diacetylmorphine

Diacetylmorphine (i.v.), daily

BEHAVIORAL

Psycho-education and Counselling

Psycho-educational group therapy and individual counselling

DRUG

Methadone

Methadone (p.o.), daily

BEHAVIORAL

Case management and Motivational interviewing

Individual Case Management combined with Motivational interviewing

Sponsors & Collaborators

• Federal Ministry of Health, Germany

  collaborator OTHER_GOV

• State of Northrhine-Westfalia

  collaborator UNKNOWN

• State of Hessen

  collaborator UNKNOWN

• State of Lower-Saxony

  collaborator UNKNOWN

• City of Hamburg

  collaborator OTHER_GOV

• City of Hanover

  collaborator OTHER_GOV

• City of Frankfurt

  collaborator OTHER_GOV

• City of Bonn

  collaborator UNKNOWN

• City of Cologne

  collaborator UNKNOWN

• City of Munich

  collaborator OTHER_GOV

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Dieter Naber, MD · University of Hamburg-Eppendorf

• Christian Haasen, MD · University of Hamburg-Eppendorf

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

23 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-03-31

Primary Completion

2003-12-31

Completion

2007-12-31

Countries

• Germany

Study Locations