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

February 13, 2014 updated by: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

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

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.

Study Overview

Status

Completed

Conditions

Heroin Addiction

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 Type

Observational

Enrollment (Actual)

515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Bad Honnef, Germany, D-53604
    - Facharzt für Allgemeinmedizin
  - Berlin, Germany, D-10551
    - Praxis Turmstrasse
  - Bonn, Germany, D-53113
    - Praktischer Arzt
  - Bremen, Germany, D-28719
    - Arzt für Allgemeinmedizin
  - Bremen, Germany, D-28719
    - Psychiatrie
  - Fürstenfeldbruck, Germany, D- 82256
    - Dres. Beck & Hummel Artzegemeinschaft
  - Halle (Saale), Germany, D-06132
    - Gemeinschaftspraxis fur Neurologie, Psychiatrie und Suchtmedizin Poliklinik Silberhohe
  - Hamburg, Germany, D-20246
    - Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik fur Psychiatrie und Psychotherapie
  - Hamburg, Germany, D-20357
    - Arzt für Allgemeinmedizin
  - Hamburg, Germany, D-22143
    - Gemeinschaftspraxis Suchtmedizin
  - Hamburg, Germany, D-22147
    - Fachgebiet Allgemeinmedizin
  - Kassel, Germany, D-34117
    - Praxiszentrum Friedrichsplatz
  - Koln, Germany, D-50679
    - Praxis
  - Lehrte, Germany, D-31275
    - Facharzt für Psychiatrie Psychotherapie
  - Leipzig, Germany, D-04107
    - Facharzt für Innere Medizin
  - München, Germany, D-80331
    - Praxiszentrum im Tal
  - München, Germany, D-80339
    - Praxis
  - München, Germany, D-80801
    - Concept Schwerpunktpraxis Sucht
  - Münster, Germany, D-48147
    - Facharzt fur Psychiatrie
  - Regensburg, Germany, D-93051
    - Hausärztliche Praxis
  - Regensburg, Germany, D-93053
    - Bezirksklinik Regensburg
  - Ulm, Germany, D-89073
    - Psychatrie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and female patients with heroin addiction, over 18 years of age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
pts addicted to heroin in MMT patients addicted to heroin who have undertaken methadone maintenance treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints Time Frame: 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.	From baseline to end of study (12 months after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)