Status:
COMPLETED
The German Project of Heroin Assisted Treatment of Opiate Dependent Patients
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Federal Ministry of Health, Germany
State of Northrhine-Westfalia
Conditions:
Opioid Dependence
Eligibility:
All Genders
23+ years
Phase:
PHASE3
Brief 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 dr...
Detailed Description
Detailed description of study phase 1 (randomized, controlled part of study) only. Part B - Study phase 1 B1.1 Clinical hypothesis Compared to maintenance with oral methadone, heroin treatment leads ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT00268814
Start Date
March 1 2002
End Date
December 1 2007
Last Update
September 9 2015
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
AWO Ambulanz
Karlsruhe, Baden-Wuertenberg, Germany, 76133
2
Heroinambulanz
Munich, Bavaria, Germany, 80336
3
Pro Vivere Drogenambulanz
Hamburg, Hamburg, Germany, 20097
4
Studienambulanz
Frankfurt am Main, Hesse, Germany, 60316