The German Project of Heroin Assisted Treatment of Opiate Dependent Patients - Full Text View

Sponsor:	Universitätsklinikum Hamburg-Eppendorf
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

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase III Study of Maintenance Treatment for Opiate Dependence With Heroin (Diamorphine) Compared to Methadone

Resource links provided by NLM:

Drug Information available for: Methadone Diacetylmorphine Methadone hydrochloride Diacetylmorphine hydrochloride

U.S. FDA Resources

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

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

Locations

Germany
Pro Vivere Drogenambulanz
Hamburg, Germany, 20097
Germany, Baden-Wuertenberg
AWO Ambulanz
Karlsruhe, Baden-Wuertenberg, Germany, 76133
Germany, Bavaria
Heroinambulanz
Munich, Bavaria, Germany, 80336
Germany, Hessen
Studienambulanz
Frankfurt, Hessen, Germany, 60316
Germany, Lower-Syxony
Drogenambulanz Hannover
Hannover, Lower-Syxony, Germany, 30159
Germany, Northrhine-Westfalia
Heroinambulanz Koeln
Cologne, Northrhine-Westfalia, Germany, 50676
Heroinambulanz Bonn
Bonn, Northrhine-Westfalia, Germany, 53111

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:

Webpage with information on the trial This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Respiratory System Agents
Heroin
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010