The German Project of Heroin Assisted Treatment of Opiate Dependent Patients

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Heroin; Methadone

Criteria

Inclusion Criteria:

• Minimum age 23 years

• Opiate dependency for at least 5 years

• Current main diagnosis of opiate dependency according to the ICD-10 criteria

• Current daily and predominantly intravenous heroin consumption or continuing heroin consumption in maintenance treatment

• Symptoms of physical illness indicating a poor state of health according to the OTI health scale; at least 13 current symptoms must be found OR Current mental symptoms or disturbances, i.e. a standardised GSI value of the SCL-90-R (Franke 1995) of at least 60 points

• No participation in an addiction treatment programme (a.a. maintenance, inpatient or outpatient treatment) at least within the last 6 months, but documented previous experience with drug therapies OR Negative course of maintenance treatment according to the guidelines of the German Medi¬cal Council (Bundesärztekam¬mer 1997) due to (a) continuous additional consumption of heroin (50% of the urine samples positive within the last 6 months) or cocaine (harmful use of cocaine/crack according to ICD-10) in a documented maintenance period of at least 6 months with a current maintenance dose of at least 60 mg d l methadone (or 30 mg levo¬methadone) daily

• Residence or registration in the city (or city state) or region that conducts the heroin treat¬ment for at least 12 months

• Voluntary participation and ability to comply with the treatment conditions (willingness to change treatment location; compliance; treatment control/documentation; evalua¬tion)

• Written consent to comply with the treatment conditions.

Exclusion Criteria:

• Persons who are currently in prison or awaiting trial or who can be expected to be taken into custody within the next 3 months

• Persons who had voluntary phases of abstinence of at least 2 months during the last 12 months

• Known epilepsy or generalised convulsions during the last 12 months

• Hypersensitivity to test substances and additives

• Regular intake of MAO inhibitors

• Serious bronchial asthma, COPD, Cor pulmonale

• Serious cardiac arrhythmia

• Prostatic hypertrophy (with urinary retention)

• Urethral stricture

• Life threatening liver disorders (exogenous hepatic coma)

• Serious renal disorders

• Insulin dependent diabetes mellitus

• Diagnosed malignancies during the last 6 months

• Pregnant women or nursing mothers

• Patients, who, according to the study physician's judgement, are not able to comply with the conditions of the model project, i.e. participation in the therapeutic and scientific pro¬grammes, due to serious physical or mental illness

• Patients who are currently participating in another clinical study concerned with the evalua¬tion of an addiction treatment programme.