Pharmacokinetic Modeling of Methadone (PKMETHAHOME)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Toxicomania
• Intervention / Treatment: Biological: Blood sampling

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoann Cazaubon, phD,pharmD; Phone Number: +33467336261; Email: yoann.cazaubon@chu-montpellier.fr
• Study Contact Backup: Name: Hélène Donnadieu-Rigole, phD,MD; Phone Number: +33467337811; Email: h-donnadieu_rigole@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Contact: Hélène Donnadieu, MD; Phone Number: +33467338154; Email: h-donnadieu@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Major patients on methadone on the same dosage for at least 7 days.
• Hospitalization for withdrawal in the addictology department of La Colombière or consultation within the unit for the treatment of drug addiction and dependence (Addictology Department).
• 24 hours monitoring is possible and accepted

Exclusion Criteria:

• Patients that cannot be sampled because of weakened veins
• Unable to received information about the study
• Exclusion period determined by previous study
• Adult protected by law or patient under guardianship
• Not affiliated to french social security system
• Not able to give written inform consent
• Pregnant or breastfeeding woman
• Underaged patients (under 18 years old)
• Patient under court protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic drug monitoring of methadone; 6 samplings per subject: 3 venipunctures and 3 microsamplings	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; Other Names: Volumetric absorptive microsampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax)	To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C12h-24h concentration	To evaluate and estimate methadone/EDDP (metabolite) concentration between 12 and 24h post-administration for patients treated for opioid addiction.	18 months
Residual concentration (C0)	To evaluate and estimate residual methadone/EDDP (metabolite) concentration for patients treated for opioid addiction.	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Yoann Cazaubon, phD,pharmD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pharmacokinetics; methadone; microsampling; modeling
• Other Study ID Numbers: 21_0614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No