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

April 27, 2016 updated by: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

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)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00178
        • U.O.C. Ser.T ASL RMC, Distretto 11
    • BO
      • Bologna, BO, Italy, 40138
        • Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est
    • MI
      • Milano, MI, Italy, 20063
        • Dipartimento delle Dipendenze ASL MI 2
    • PE
      • Pescara, PE, Italy, 65124
        • Servizio dipendenze, AUSL
    • TO
      • Torino, TO, Italy, 10149
        • Dipartimento Dipendenze, ASL TO 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients addicted to heroin and who have undertaken a methadone maintenance treatment, observed in involved centres.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
pts addicted to heroin in MMT
patients addicted to heroin who have undertaken methadone maintenance treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 )
2 years ( 7 visits for patient )

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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 )
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 )
2 years ( 7 visits for patient )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Solaris CRO

Investigators

  • Study Chair: Donatella Mariani, Solaris CRO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M.E.T.O.D.O.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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