Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The objectives are to provide further data on the safety profile after long term use and effectiveness of levomethadone, administered according Summary of Product Characteristics (SmPC) and in a real word clinical setting, in opioid-addicted patients undergoing maintenance treatment. Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions and corrected QT (QTc) prolongation at 12-lead electrocardiogram (ECG), where available. The effectiveness outcomes are the evaluation of levomethadone maintenance treatment according to investigator's judgment at V4(180 days), based on different questionnaires and assessment.

Official Title
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Observational, Prospective Study to Evaluate Levomethadone Safety Profile and Effectiveness in Subjects Under Opioid Maintenance Treatment

Conditions
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Opioid Addiction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (based on Adverse Drug Reactions) | Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions. | Safety will be described throughout all the study (maximum duration approximately 1 year). | 
| Effectiveness (Addiction Severity) | 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. | The effectiveness outcomes will be evaluated at V4 (180 days). | 
| Effectiveness (Substance use) | The patient will register on a diary the use (days) of heroin, buprenorphine, cocaine. | The effectiveness outcomes will be evaluated at V4 (180 days). | 
| Effectiveness (Presence of Catabolites) | Assessment (negative/positive) of heroin, methadone, buprenorphine, cocaine in urine. | The effectiveness outcomes will be evaluated at V4 (180 days). | 
| Effectiveness (Retention Rate) | Retention rate (days) in treatment with levomethadone. | The effectiveness outcomes will be evaluated at V4 (180 days). | 
| Effectiveness (Craving) | Craving will be assessed using by Visual Analogue Scale (VAS) (0-100mm; 0: no craving, 100: maximum craving) | The effectiveness outcomes will be evaluated at V4 (180 days). | 
| Effectiveness (Evaluation of Quality of life) | 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. | The effectiveness outcomes will be evaluated at V4 (180 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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addiction, opioid addiction, levomethadone, methadone, opioid maintenance treatment