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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    500
  • sponsor
    L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Updated on 31 March 2021
opioid
opioid dependence
addiction
maintenance treatment
levomethadone

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.

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.

Details
Condition Drug abuse, Opioid Dependence, Opioid Use Disorder, Opioid Addiction, Substance Abuse, Drug use, opiate dependence
Clinical Study IdentifierNCT03685162
SponsorL.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Last Modified on31 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Drug abuse or Opioid Use Disorder or Opioid Dependence or Opioid Addiction or Drug use or Substance Abuse?
Do you have any of these conditions: Opioid Dependence or Drug abuse or Opioid Use Disorder or Drug use or Substance Abuse or opiate dependence or Opioid Addiction?
Do you have any of these conditions: Drug abuse or Opioid Dependence or Substance Abuse or Opioid Addiction or opiate dependence or Opioid Use Disorder or Drug use?
Do you have any of these conditions: Drug abuse or Opioid Use Disorder or Drug use or opiate dependence or Opioid Addiction or Substance Abuse or Opioid Dependence?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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