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

Heroin Addiction Clinical Trial

— METHODE  

Official title:

Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062723
• Other study ID #: MOLT-2009-002
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: February 13, 2014
• Start date: September 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence

Locations

Country	Name	City	State
Germany	Facharzt für Allgemeinmedizin	Bad Honnef
Germany	Praxis Turmstrasse	Berlin
Germany	Praktischer Arzt	Bonn
Germany	Arzt für Allgemeinmedizin	Bremen
Germany	Psychiatrie	Bremen
Germany	Dres. Beck & Hummel Artzegemeinschaft	Fürstenfeldbruck
Germany	Gemeinschaftspraxis fur Neurologie, Psychiatrie und Suchtmedizin Poliklinik Silberhohe	Halle (Saale)
Germany	Arzt für Allgemeinmedizin	Hamburg
Germany	Fachgebiet Allgemeinmedizin	Hamburg
Germany	Gemeinschaftspraxis Suchtmedizin	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik fur Psychiatrie und Psychotherapie	Hamburg
Germany	Praxiszentrum Friedrichsplatz	Kassel
Germany	Praxis	Koln
Germany	Facharzt für Psychiatrie Psychotherapie	Lehrte
Germany	Facharzt für Innere Medizin	Leipzig
Germany	Concept Schwerpunktpraxis Sucht	München
Germany	Praxis	München
Germany	Praxiszentrum im Tal	München
Germany	Facharzt fur Psychiatrie	Münster
Germany	Bezirksklinik Regensburg	Regensburg
Germany	Hausärztliche Praxis	Regensburg
Germany	Psychatrie	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes