Clinical trial NCT02062723: Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT
Official title: Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heroin Addiction
Keywords: methadone
heroin addiction
methadone maintenance treatment
adequate dosage of methadone
Lead sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with heroin addiction, over 18 years of age.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary endpoint
timeFrame: From baseline to end of study (12 months after baseline)
Secondary outcomes:
measure: Secondary endpoints
timeFrame: From baseline to end of study (12 months after baseline)
Other outcomes:
Locations:
city: Bad Honnef
country: Germany
facility: Facharzt für Allgemeinmedizin
city: Berlin
country: Germany
facility: Praxis Turmstrasse
city: Bonn
country: Germany
facility: Praktischer Arzt
city: Bremen
country: Germany
facility: Arzt für Allgemeinmedizin
city: Bremen
country: Germany
facility: Psychiatrie
city: Fürstenfeldbruck
country: Germany
facility: Dres. Beck & Hummel Artzegemeinschaft
city: Halle (Saale)
country: Germany
facility: Gemeinschaftspraxis fur Neurologie, Psychiatrie und Suchtmedizin Poliklinik Silberhohe
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik fur Psychiatrie und Psychotherapie
city: Hamburg
country: Germany
facility: Arzt für Allgemeinmedizin
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis Suchtmedizin
city: Hamburg
country: Germany
facility: Fachgebiet Allgemeinmedizin
city: Kassel
country: Germany
facility: Praxiszentrum Friedrichsplatz
city: Koln
country: Germany
facility: Praxis
city: Lehrte
country: Germany
facility: Facharzt für Psychiatrie Psychotherapie
city: Leipzig
country: Germany
facility: Facharzt für Innere Medizin
city: München
country: Germany
facility: Praxiszentrum im Tal
city: München
country: Germany
facility: Praxis
city: München
country: Germany
facility: Concept Schwerpunktpraxis Sucht
city: Münster
country: Germany
facility: Facharzt fur Psychiatrie
city: Regensburg
country: Germany
facility: Hausärztliche Praxis
city: Regensburg
country: Germany
facility: Bezirksklinik Regensburg
city: Ulm
country: Germany
facility: Psychatrie
Study officials:
References: