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

October 23, 2023 updated by: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy
        • UOC Dipendenze, ASST Papa Giovanni XXIII

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (based on Adverse Drug Reactions)
Time Frame: 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.
Safety will be described throughout all the study (maximum duration approximately 1 year).
Effectiveness (Addiction Severity)
Time Frame: 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.
The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Substance use)
Time Frame: The effectiveness outcomes will be evaluated at V4 (180 days).
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)
Time Frame: The effectiveness outcomes will be evaluated at V4 (180 days).
Assessment (negative/positive) of heroin, methadone, buprenorphine, cocaine in urine.
The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Retention Rate)
Time Frame: The effectiveness outcomes will be evaluated at V4 (180 days).
Retention rate (days) in treatment with levomethadone.
The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Craving)
Time Frame: 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)
The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Evaluation of Quality of life)
Time Frame: 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.
The effectiveness outcomes will be evaluated at V4 (180 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2018

Primary Completion (Actual)

February 16, 2023

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOLT-2015-01

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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