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

NCT ID: NCT03685162

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2023-02-16

Brief Summary

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

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.

Conditions

Opioid Addiction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UOC Dipendenze, ASST Papa Giovanni XXIII

Bergamo, , Italy

Countries

Italy

Other Identifiers

MOLT-2015-01

Identifier Type: -

Identifier Source: org_study_id