Trial Synopsis

Observational Study to Assess the Adequacy of Methadone Dosage,
in Heroin Addicted Patients in a MMT.
Status: Completed
Study Phase: N/A
Start Date: February 2010 | Completion Date: March 2014
Condition(s): Heroin Addiction
Full Title of Study
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)
Overview
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 DSMIV_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 Details
Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective
Investigator Details
Lead Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Collaborator: Solaris CRO
Study Chair: Donatella Mariani Solaris CRO
Trial Location Details
Facility: Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est
Bologna, Italy
Facility: Dipartimento delle Dipendenze ASL MI 2 Milano, Italy
Facility: Servizio dipendenze, AUSL Pescara, Italy
Facility: Dipartimento Dipendenze, ASL TO 2 Torino, Italy
Facility: U.O.C. Ser.T ASL RMC, Distretto 11 Roma, Italy
Published Research
D'Egidio PF, Bignamini E, De Vivo E, Leonardi C, Pieri MC, González-Saiz F, Lucchini A; METODO Study Team. METODO, a prospective
observational study to assess the efficacy and tolerability of methadone in heroin-addicted patients undergoing a methadone
maintenance treatment: preliminary results at baseline evaluation. Subst Use Misuse. 2013 Dec;48(14):1530-40. doi:
10.3109/10826084.2013.800886. Epub 2013 Jul 3.
Information Source
ID Number: M.E.T.O.D.O.
NCT Identifier: NCT02062736
Health Authority: Italy: Ethics Committee
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT02062736
ClinicalTrials.gov processed this data on July 05, 2016
by this site. Please see the full source link above for retrieving further details from the government database.