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Completed

NCT Number: NCT02062736

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

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.

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Key information

Conditions

Heroin Addiction Chemically-Induced Disorders Heroin Dependence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 )

Secondary outcomes

  1. 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. 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 )

  3. pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.

    Time frame: 2 years ( 7 visits for patient )

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Solaris CRO

Registry information

Official study 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)

Acronym: METODO

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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