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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est
Bologna, BO, Italy
Dipartimento delle Dipendenze ASL MI 2
Milan, MI, Italy
Servizio dipendenze, AUSL
Pescara, PE, Italy
Dipartimento Dipendenze, ASL TO 2
Torino, TO, Italy
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.
Time frame: 2 years ( 7 visits for patient )
QT prolongation risk in patients addicted to heroin who have undertaken MMT
Time frame: 2 years ( evaluation at t0, t0 +6/12/18/24 months)
psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages
Time frame: 2 years ( 7 visits for patient )
pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.
Time frame: 2 years ( 7 visits for patient )
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U.O.C. Ser.T ASL RMC, Distretto 11
Roma, Italy