Clinical trial NCT02062736: Observational Study to Assess the Adequacy of Methadone Dosage, in Heroin Addicted Patients in a MMT.
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heroin Addiction
Keywords: methadone
heroin addiction
methadone maintenance treatment
adequate dosage of methadone
Lead sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Solaris CRO
First posted: 2014-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients addicted to heroin and who have undertaken a methadone maintenance treatment, observed in involved centres.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years ( 7 visits for patient )
Secondary outcomes:
measure: QT prolongation risk in patients addicted to heroin who have undertaken MMT
timeFrame: 2 years ( evaluation at t0, t0 +6/12/18/24 months)
measure: psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages
timeFrame: 2 years ( 7 visits for patient )
measure: pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.
timeFrame: 2 years ( 7 visits for patient )
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est
state: BO
city: Milano
country: Italy
facility: Dipartimento delle Dipendenze ASL MI 2
state: MI
city: Pescara
country: Italy
facility: Servizio dipendenze, AUSL
state: PE
city: Torino
country: Italy
facility: Dipartimento Dipendenze, ASL TO 2
state: TO
city: Roma
country: Italy
facility: U.O.C. Ser.T ASL RMC, Distretto 11
Study officials:
affiliation: Solaris CRO
name: Donatella Mariani
role: STUDY_CHAIR
References:
citation: D'Egidio PF, Bignamini E, De Vivo E, Leonardi C, Pieri MC, Gonzalez-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.