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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Inability to follow the observation
- •Diagnosis of decompensated psychotic disorders
结局指标
主要结局
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.
时间窗: 2 years ( 7 visits for patient )
次要结局
- 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 ))