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

Heroin Addiction Clinical Trial

— METODO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062736
• Other study ID #: M.E.T.O.D.O.
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: April 27, 2016
• Start date: February 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2016
• Source: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence

Locations

Country	Name	City	State
Italy	Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est	Bologna	BO
Italy	Dipartimento delle Dipendenze ASL MI 2	Milano	MI
Italy	Servizio dipendenze, AUSL	Pescara	PE
Italy	U.O.C. Ser.T ASL RMC, Distretto 11	Roma
Italy	Dipartimento Dipendenze, ASL TO 2	Torino	TO

Sponsors (2)

Lead Sponsor	Collaborator
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.	Solaris CRO

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years ( 7 visits for patient )	No
Secondary	QT prolongation risk in patients addicted to heroin who have undertaken MMT		2 years ( evaluation at t0, t0 +6/12/18/24 months)	Yes
Secondary	psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages		2 years ( 7 visits for patient )	Yes
Secondary	pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.		2 years ( 7 visits for patient )	No