Observational, Prospective Study to Evaluate Levomethadone Safety Profile and Effectiveness in Subjects Under Opioid Maintenance Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Safety (based on Adverse Drug Reactions)
研究概览
简要总结
Multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to ICD-10 (F11.2), treated with therapeutic doses of levomethadone according to the routine medical practice.
详细描述
Multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to ICD-10 (F11.2), treated with therapeutic doses of levomethadone according to the routine medical practice.
The study is divided in two different consecutive parts:
- Part 1 [from Informed Consent form (ICF) to last data collected at V4]: patients enrolled are receiving levomethadone maintenance treatment according to clinical practice.
- Part 2 (after V4 up to FU): patients are in opioid maintenance treatment with any drug (including levomethadone) according to clinical practice.
The maximum duration on-study for a patient will be 405 days [from ICF signature (-30 days from V1) to FU (=360 + 15)]. This study is an open-ended trial. This means that for the enrolment and for the study, no maximum duration has been established.
The study, which is a voluntary Post Authorization Safety Study (PASS), will be carried out on approximately 10 centers in Italy.
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
- •Male and female patients, aged ≥ 18 years;
- •Patients with a diagnosis of opioid addiction according to ICD-10 (ICD 10 F11.2);
- •Opioid-addicted patients initiating or currently undergoing a maintenance treatment with levomethadone as part of their routine clinical care and according to the approved SmPC;
- •Patients or legal guardian when applicable must provide their written informed consent to participate in the study.
排除标准
- •Inability to understand study procedures;
- •Any contraindication stated in the SmPC for the administration of levomethadone according to investigator's judgment;
- •Patients currently participating in any other clinical trial.
结局指标
主要结局
Safety (based on Adverse Drug Reactions)
时间窗: Safety will be described throughout all the study (maximum duration approximately 1 year).
Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions.
Effectiveness (Craving)
时间窗: The effectiveness outcomes will be evaluated at V4 (180 days).
Craving will be assessed using by Visual Analogue Scale (VAS) (0-100mm; 0: no craving, 100: maximum craving)
Effectiveness (Substance use)
时间窗: The effectiveness outcomes will be evaluated at V4 (180 days).
The patient will register on a diary the use (days) of heroin, buprenorphine, cocaine.
Effectiveness (Presence of Catabolites)
时间窗: The effectiveness outcomes will be evaluated at V4 (180 days).
Assessment (negative/positive) of heroin, methadone, buprenorphine, cocaine in urine.
Effectiveness (Retention Rate)
时间窗: The effectiveness outcomes will be evaluated at V4 (180 days).
Retention rate (days) in treatment with levomethadone.
Effectiveness (Evaluation of Quality of life)
时间窗: The effectiveness outcomes will be evaluated at V4 (180 days).
The evaluation of quality of life will be carried out with the Quality of Life Short-Form Health Survey questionnaire (SF-12). This questionnaire takes into account two domains: Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) where the lower the score the more disability and the higher the score the less disability.
Effectiveness (Addiction Severity)
时间窗: The effectiveness outcomes will be evaluated at V4 (180 days).
Assessed by Addiction Severity Index (ASI); ASI is a semi-structured interview that consent to assess addiction severity (scale 0-9; 0: no problems, 9: severe problems) of the patient in 7 problem areas.
次要结局
未报告次要终点