Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT

Completed

• Conditions: Heroin Addiction

• Registration Number: NCT02062723
• Lead Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2014-01-24
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-13
• Last Update Submitted: 2014-02-13
• Study First Posted: 2014-02-14
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

• 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

Exclusion Criteria

• 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,
  • Severe-acute or severe-chronic somatic diseases (like AIDS, Tubercolosis, acute hepatitis, Sepsis ecc), whereas chronical HCV is not an exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint	From baseline to end of study (12 months after baseline)	Efficacy and Tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints	From baseline to end of study (12 months after baseline)	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.

Trial Locations

Locations (20)

Praktischer Arzt; 🇩🇪 Bonn, Germany

Praxis Turmstrasse; 🇩🇪 Berlin, Germany

Psychatrie; 🇩🇪 Ulm, Germany

Praxiszentrum Friedrichsplatz; 🇩🇪 Kassel, Germany

Praxis; 🇩🇪 München, Germany

Facharzt für Psychiatrie Psychotherapie; 🇩🇪 Lehrte, Germany

Facharzt für Innere Medizin; 🇩🇪 Leipzig, Germany

Gemeinschaftspraxis fur Neurologie, Psychiatrie und Suchtmedizin Poliklinik Silberhohe; 🇩🇪 Halle (Saale), Germany

Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik fur Psychiatrie und Psychotherapie; 🇩🇪 Hamburg, Germany

Gemeinschaftspraxis Suchtmedizin; 🇩🇪 Hamburg, Germany

Facharzt für Allgemeinmedizin; 🇩🇪 Bad Honnef, Germany

Psychiatrie; 🇩🇪 Bremen, Germany

Arzt für Allgemeinmedizin; 🇩🇪 Hamburg, Germany

Fachgebiet Allgemeinmedizin; 🇩🇪 Hamburg, Germany

Dres. Beck & Hummel Artzegemeinschaft; 🇩🇪 Fürstenfeldbruck, Germany

Praxiszentrum im Tal; 🇩🇪 München, Germany

Concept Schwerpunktpraxis Sucht; 🇩🇪 München, Germany

Facharzt fur Psychiatrie; 🇩🇪 Münster, Germany

Bezirksklinik Regensburg; 🇩🇪 Regensburg, Germany

Hausärztliche Praxis; 🇩🇪 Regensburg, Germany