The German Project of Heroin Assisted Treatment of Opiate Dependent Patients

NCT00268814 | Completed Phase 3 DMC

• 1 other identifier: ZIS-HV9-0701
• Study Type: interventional
• Target: 1,015
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (2)

• (A) Improvement of physical or mental state of health,

  12 months

• (B) Reduction of consumption of street heroin and no increase of cocaine use.

  12 months

Secondary Outcomes (8)

• Retention rate

  12 months

• Reduction of consumption of, benzodiazepines, amphetamine, alcohol and other substances

  12 months

• Detachment from the drug scene

  12 months

• Decrease of criminal behaviour

  12 months

• Stabilisation of the living situation

  12 months

Study Arms (8)

MTF, Psycho-education, Heroin

EXPERIMENTAL

Stratum: Methadone treatment failures (MTF) Intervention: Psycho-education and Counselling, Drug: Diacetylmorphine (i.v.)

Drug: Diacetylmorphine; Behavioral: Psycho-education and Counselling

MTF, Case management, Heroin

EXPERIMENTAL

Stratum: Methadone treatment failures (MTF) Intervention: Case Management and Motivational Interviewing, Drug: Diacetylmorphine (i.v.)

Drug: Diacetylmorphine; Behavioral: Case management and Motivational interviewing

MTF, Psycho-education, Methadone

ACTIVE COMPARATOR

Stratum: Methadone treatment failures (MTF) Intervention: Psycho-education and Counselling, Drug: Methadone (p.o.)

Behavioral: Psycho-education and Counselling; Drug: Methadone

MTF, Case management, Methadone

ACTIVE COMPARATOR

Stratum: Methadone treatment failures (MTF) Intervention: Case Management and Motivational Interviewing, Drug: Methadone (p.o.)

Drug: Methadone; Behavioral: Case management and Motivational interviewing

NIT, Psycho-education, Heroin

EXPERIMENTAL

Stratum: Not in treatment (NIT) Intervention: Psycho-education and Counselling, Drug: Diacetylmorphine (i.v.)

Drug: Diacetylmorphine; Behavioral: Psycho-education and Counselling

NIT, Case management, Heroin

EXPERIMENTAL

Stratum: Not in treatment (NIT) Intervention: Case Management and Motivational Interviewing, Drug: Diacetylmorphine (i.v.)

Drug: Diacetylmorphine; Behavioral: Case management and Motivational interviewing

NIT, Psycho-education, Methadone

ACTIVE COMPARATOR

Stratum: Not in treatment (NIT) Intervention: Psycho-education and Counselling, Drug: Methadone (p.o.)

Behavioral: Psycho-education and Counselling; Drug: Methadone

NIT, Case management, Methadone

ACTIVE COMPARATOR

Stratum: Not in treatment (NIT) Intervention: Case Management and Motivational Interviewing, Drug: Methadone (p.o.)

Drug: Methadone; Behavioral: Case management and Motivational interviewing

Interventions

Diacetylmorphine DRUG

Diacetylmorphine (i.v.), daily

Also known as: Heroin

MTF, Case management, Heroin; MTF, Psycho-education, Heroin; NIT, Case management, Heroin; NIT, Psycho-education, Heroin

Psycho-education and Counselling BEHAVIORAL

Psycho-educational group therapy and individual counselling

MTF, Psycho-education, Heroin; MTF, Psycho-education, Methadone; NIT, Psycho-education, Heroin; NIT, Psycho-education, Methadone

Methadone DRUG

Methadone (p.o.), daily

Also known as: racemic d,l-methadone

MTF, Case management, Methadone; MTF, Psycho-education, Methadone; NIT, Case management, Methadone; NIT, Psycho-education, Methadone

Case management and Motivational interviewing BEHAVIORAL

Individual Case Management combined with Motivational interviewing

MTF, Case management, Heroin; MTF, Case management, Methadone; NIT, Case management, Heroin; NIT, Case management, Methadone

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Federal Ministry of Health, Germany: collaborator
• State of Northrhine-Westfalia: collaborator
• State of Hessen: collaborator
• State of Lower-Saxony: collaborator
• City of Hamburg: collaborator
• City of Hanover: collaborator
• City of Frankfurt: collaborator
• City of Bonn: collaborator
• City of Cologne: collaborator
• City of Munich: collaborator

Study Sites (7)

AWO Ambulanz

Karlsruhe, Baden-Wuertenberg, 76133, Germany

Location

Heroinambulanz

Munich, Bavaria, 80336, Germany

Location

Pro Vivere Drogenambulanz

Hamburg, Hamburg, 20097, Germany

Location

Studienambulanz

Frankfurt am Main, Hesse, 60316, Germany

Location

Drogenambulanz Hannover

Hanover, Lower-Syxony, 30159, Germany

Location

Heroinambulanz Bonn

Bonn, Northrhine-Westfalia, 53111, Germany

Location

Heroinambulanz Koeln

Cologne, Northrhine-Westfalia, 50676, Germany

Location

Related Links

• Webpage with information on the trial

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Heroin; Counseling; Methadone; Case Management; Motivational Interviewing

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Ketones; Organic Chemicals; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Directive Counseling

Study Officials

• Dieter Naber, MD

  University of Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Christian Haasen, MD

  University of Hamburg-Eppendorf

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Centre for Interdisciplinary Addiction Research

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 22, 2005
• Study Start: March 1, 2002
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2007
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

DE (7)