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

Completed

• Conditions: Heroin Addiction

• Registration Number: NCT02062736
• Lead Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2014-01-24
• Primary Completion: 2014-02
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Study Completion: 2014-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 )

Secondary Outcome Measures

Name	Time	Method
pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.	2 years ( 7 visits for patient )
QT prolongation risk in patients addicted to heroin who have undertaken MMT	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	2 years ( 7 visits for patient )

Trial Locations

Locations (5)

Dipartimento delle Dipendenze ASL MI 2; 🇮🇹 Milano, MI, Italy

Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est; 🇮🇹 Bologna, BO, Italy

Servizio dipendenze, AUSL; 🇮🇹 Pescara, PE, Italy

Dipartimento Dipendenze, ASL TO 2; 🇮🇹 Torino, TO, Italy

U.O.C. Ser.T ASL RMC, Distretto 11; 🇮🇹 Roma, Italy