Observational Study to Assess the Adequacy of Methadone Dosage, in Heroin Addicted Patients in a MMT. — METODO  

Heroin Addiction Clinical Trial

Official title: Studio Osservazionale Per Valutare l'Adeguatezza Del Dosaggio Del Metadone, Nelle Terapie di Mantenimento, in Rapporto Agli Obbiettivi di Outcome, in Pazienti Tossicodipendenti da Eroina. (METODO)

Status Completed

Clinical Trial Summary

The purpose of the study ( observational and prospective ) is to evaluate the efficacy and tolerability of the methadone maintenance treatment in patients addicted to heroin. The efficacy and tolerability are assessed by correlating to the adequacy of the dosage of methadone. The patients will be observed for two years.

Clinical Trial Description

500 patients will be selected among all patients addicted to heroin according to DSM-IV_TR (Diagnostic and Statistical Manual of Mental Disorders IV_ text revision), in maintenance methadone treatment, observed in the involved sites. The investigators will use treatment schemes with methadon conform to clinical practice and according to SPC (Summary of Product Characteristics).

The enrollment will be competitive. Patients that meet incl/excl and that sign the informed consent, will be observed for 2 years. Follow up visits will be performed according to routine procedures, for patients that belong regularly to site at 3/6/9/12/18/24 months post V1. During the visits, patients will be assessed by validated and used as clinical practice questionnaires . For the evaluations of tolerability and safety the laboratory tests and electrocardiograms routinely performed will be collected. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence

• NCT number: NCT02062736
• Study type: Observational
• Source: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Completion date: March 2014