The German Project of Heroin Assisted Treatment of Opiate Dependent Patients
This study has been completed.
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
First received: December 21, 2005
Last updated: NA
Last verified: August 2001
History: No changes posted
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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
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 May 16, 2013