NCT05490732

Pharmacokinetic Modeling of Methadone

Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

• Toxicomania

Interventions

Type	Name	Description
BIOLOGICAL	Blood sampling	Patient will be subjected to 3 blood sampling over 24hours. At H0, H4 and H12-24. For each one, one microsampling and one venipuncture

Timeline

• Start date: 2024-03-23
• Primary completion: 2025-04-01
• Completion: 2025-09-01
• First posted: 2022-08-08
• Last updated: 2024-11-21

Locations

1 site across 1 country: France