The German Project of Heroin Assisted Treatment of Opiate Dependent Patients

This study has been completed.
Sponsor:
Collaborators:
Federal Ministry of Health, Germany
State of Northrhine-Westfalia
State of Hessen
State of Lower-Saxony
City of Hamburg
City of Hanover
City of Frankfurt
City of Bonn
City of Cologne
City of Munich
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00268814
First received: December 21, 2005
Last updated: NA
Last verified: August 2001
History: No changes posted
  Purpose

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 accessability 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 desing 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.


Condition Intervention Phase
Opioid Dependence (ICD-10: F11.2)
Drug: diacetylmorphine vs. methadone
Behavioral: Case management & MI vs. counselling & psychoeducation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Maintenance Treatment for Opiate Dependence With Heroin (Diamorphine) Compared to Methadone

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • (A) Improvement of physical or mental state of health,
  • (B) Reduction of consumption of street heroin and no increase of cocaine use.

Secondary Outcome Measures:
  • Retention rate,
  • Reduction of consumption of, benzodiazepines, amphetamine, alcohol and other substances,
  • Detachment from the drug scene,
  • Decrease of criminal behaviour,
  • Stabilisation of the living situation,
  • Establishment of new social contacts,
  • Improvement of quality of life,
  • Mortality rate

Estimated Enrollment: 1120
Study Start Date: March 2002
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268814

Locations
Germany
AWO Ambulanz
Karlsruhe, Baden-Wuertenberg, Germany, 76133
Heroinambulanz
Munich, Bavaria, Germany, 80336
Studienambulanz
Frankfurt, Hessen, Germany, 60316
Drogenambulanz Hannover
Hannover, Lower-Syxony, Germany, 30159
Heroinambulanz Bonn
Bonn, Northrhine-Westfalia, Germany, 53111
Heroinambulanz Koeln
Cologne, Northrhine-Westfalia, Germany, 50676
Pro Vivere Drogenambulanz
Hamburg, Germany, 20097
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Federal Ministry of Health, Germany
State of Northrhine-Westfalia
State of Hessen
State of Lower-Saxony
City of Hamburg
City of Hanover
City of Frankfurt
City of Bonn
City of Cologne
City of Munich
Investigators
Principal Investigator: Dieter Naber, MD Universitätsklinikum Hamburg-Eppendorf
Study Director: Christian Haasen, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00268814     History of Changes
Other Study ID Numbers: ZIS-HV9-0701
Study First Received: December 21, 2005
Last Updated: December 21, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Heroin
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 28, 2014