Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT
METHODE
Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment
1 other identifier
observational
515
1 country
22
Brief Summary
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedFebruary 14, 2014
February 1, 2014
2.4 years
January 24, 2014
February 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoint
Efficacy and Tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin.
From baseline to end of study (12 months after baseline)
Secondary Outcomes (1)
Secondary endpoints
From baseline to end of study (12 months after baseline)
Study Arms (1)
pts addicted to heroin in MMT
patients addicted to heroin who have undertaken methadone maintenance treatment
Eligibility Criteria
Male and female patients with heroin addiction, over 18 years of age.
You may qualify if:
- Both sexes
- Over 18 years of age
- Patients with a diagnosis of heroin addiction, according to ICD-10 (International Classification of Diseases-10)
- Patients who receive a "maintenance treatment" with Eptadone® since at least one month
- Accession to the observational study by informed consent
You may not qualify if:
- Inability to follow the observation and to understand study procedure and follow them
- Diagnosis of:
- Decompensated psychotic disorders,
- Epileptic attacks, not related with drug abuse,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Facharzt für Allgemeinmedizin
Bad Honnef, D-53604, Germany
Praxis Turmstrasse
Berlin, D-10551, Germany
Praktischer Arzt
Bonn, D-53113, Germany
Arzt für Allgemeinmedizin
Bremen, D-28719, Germany
Psychiatrie
Bremen, D-28719, Germany
Praxis
Cologne, D-50679, Germany
Dres. Beck & Hummel Artzegemeinschaft
Fürstenfeldbruck, D- 82256, Germany
Gemeinschaftspraxis fur Neurologie, Psychiatrie und Suchtmedizin Poliklinik Silberhohe
Halle, D-06132, Germany
Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik fur Psychiatrie und Psychotherapie
Hamburg, D-20246, Germany
Arzt für Allgemeinmedizin
Hamburg, D-20357, Germany
Gemeinschaftspraxis Suchtmedizin
Hamburg, D-22143, Germany
Fachgebiet Allgemeinmedizin
Hamburg, D-22147, Germany
Praxiszentrum Friedrichsplatz
Kassel, D-34117, Germany
Facharzt für Psychiatrie Psychotherapie
Lehrte, D-31275, Germany
Facharzt für Innere Medizin
Leipzig, D-04107, Germany
Praxiszentrum im Tal
München, D-80331, Germany
Praxis
München, D-80339, Germany
Concept Schwerpunktpraxis Sucht
München, D-80801, Germany
Facharzt fur Psychiatrie
Münster, D-48147, Germany
Hausärztliche Praxis
Regensburg, D-93051, Germany
Bezirksklinik Regensburg
Regensburg, D-93053, Germany
Psychatrie
Ulm, D-89073, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2014
First Posted
February 14, 2014
Study Start
September 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 14, 2014
Record last verified: 2014-02