Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT
NCT ID: NCT02062723
Last Updated: 2014-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
515 participants
OBSERVATIONAL
2010-09-30
2013-02-28
Brief Summary
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Detailed Description
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The enrollment has been competitive. Patients met incl/excl and that have signed the informed consent have been observed for 1 year. Follow up visits have been performed according to routine procedures, for patients related to the centres at 3/6/12 months post V1. During the visits patients have been assessed by validated and used as clinical practice questionaries. Safety and tolerability have been assessed through the collection of adverse reactions and of laboratory tests.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pts addicted to heroin in MMT
patients addicted to heroin who have undertaken methadone maintenance treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Diagnosis of:
* Decompensated psychotic disorders,
* Epileptic attacks, not related with drug abuse,
18 Years
ALL
No
Sponsors
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L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
INDUSTRY
Responsible Party
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Locations
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Facharzt für Allgemeinmedizin
Bad Honnef, , Germany
Praxis Turmstrasse
Berlin, , Germany
Praktischer Arzt
Bonn, , Germany
Arzt für Allgemeinmedizin
Bremen, , Germany
Psychiatrie
Bremen, , Germany
Praxis
Cologne, , Germany
Dres. Beck & Hummel Artzegemeinschaft
Fürstenfeldbruck, , Germany
Gemeinschaftspraxis fur Neurologie, Psychiatrie und Suchtmedizin Poliklinik Silberhohe
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik fur Psychiatrie und Psychotherapie
Hamburg, , Germany
Arzt für Allgemeinmedizin
Hamburg, , Germany
Gemeinschaftspraxis Suchtmedizin
Hamburg, , Germany
Fachgebiet Allgemeinmedizin
Hamburg, , Germany
Praxiszentrum Friedrichsplatz
Kassel, , Germany
Facharzt für Psychiatrie Psychotherapie
Lehrte, , Germany
Facharzt für Innere Medizin
Leipzig, , Germany
Praxiszentrum im Tal
München, , Germany
Praxis
München, , Germany
Concept Schwerpunktpraxis Sucht
München, , Germany
Facharzt fur Psychiatrie
Münster, , Germany
Hausärztliche Praxis
Regensburg, , Germany
Bezirksklinik Regensburg
Regensburg, , Germany
Psychatrie
Ulm, , Germany
Countries
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Other Identifiers
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MOLT-2009-002
Identifier Type: -
Identifier Source: org_study_id
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