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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.
515 patients have been selected among all patients addicted to heroin according ICD-10, in maintenance treatment with Eptadone, observed in the involved sites. The investigators have used the treatment schemes with Eptadone conform to the registered use.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pts addicted to heroin in MMT | patients addicted to heroin who have undertaken methadone maintenance treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints | Pharmacoeconomic evaluation of the maintenance treatment with Eptadone®; compliance of patients to the treatment with Eptadone®; efficacy of Eptadone® in relation to sex and group of age; effects of methadone on sexual functioning. | From baseline to end of study (12 months after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
Inability to follow the observation and to understand study procedure and follow them
Diagnosis of:
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Male and female patients with heroin addiction, over 18 years of age.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facharzt für Allgemeinmedizin | Bad Honnef | D-53604 | Germany | |||
| Praxis Turmstrasse |
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| 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 |
| ID | Term |
|---|---|
| D006556 | Heroin Dependence |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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