DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heroin Addiction

Phase: N/A

Status: Active, not recruiting

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

Official(s) and/or principal investigator(s):
Donatella Mariani, Study Chair, Affiliation: Solaris CRO


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 Details

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)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: the efficacy of the methadone maintenance treatment in addicted heroin patients, evaluating the correlation among efficacy and adequate dosage in comparison to not adequate dosage.

Secondary outcome:

QT prolongation risk in patients addicted to heroin who have undertaken MMT

psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages

pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Both sexes

- Over 18 years of age

- Patients with a diagnosis of heroin addiction according to ICD-10 (International

Classification of Diseases)

- Patients who have undertaken a methadone maintenance treatment

- Adhesion to observational study by signing informed consent.

Exclusion Criteria:

- Inability to follow the observation

- Diagnosis of decompensated psychotic disorders

Locations and Contacts

U.O.C. Ser.T ASL RMC, Distretto 11, Roma 00178, Italy

Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est, Bologna, BO 40138, Italy

Dipartimento delle Dipendenze ASL MI 2, Milano, MI 20063, Italy

Servizio dipendenze, AUSL, Pescara, PE 65124, Italy

Dipartimento Dipendenze, ASL TO 2, Torino, TO 10149, Italy

Additional Information

Related publications:

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.

Starting date: February 2010
Last updated: February 12, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017