NCT02062736

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

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
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heroin Addiction

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2014-02-14
• Last updated: 2016-04-28

Locations

5 sites across 1 country: Italy