Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT05490732

Pharmacokinetic Modeling of Methadone

Led by University Hospital, Montpellier · Updated on 2024-11-21

100

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.

CONDITIONS

Official Title

Pharmacokinetic Modeling of Methadone

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Receiving methadone at the same dose for at least 7 days
  • Hospitalized for withdrawal in the addictology department of La Colombière or attending consultation at the drug addiction treatment unit
  • Able and willing to undergo 24 hours of monitoring
Not Eligible

You will not qualify if you...

  • Patients with weakened veins preventing blood sampling
  • Unable to receive or understand information about the study
  • Within an exclusion period from a previous study
  • Adults protected by law or under guardianship
  • Not affiliated with the French social security system
  • Unable to give written informed consent
  • Pregnant or breastfeeding women
  • Under 18 years old
  • Patients under court protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Montpellier

Montpellier, France

Actively Recruiting

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Research Team

Y

Yoann Cazaubon, phD,pharmD

CONTACT

H

Hélène Donnadieu-Rigole, phD,MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Pharmacokinetic Modeling of Methadone | DecenTrialz