Pharmacokinetic Modeling of Methadone

Toxicomania Clinical Trial

— PKMETHAHOME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05490732
• Other study ID #: 21_0614
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: March 2024
• Source: University Hospital, Montpellier
• Contact: Yoann Cazaubon, phD,pharmD
• Phone: +33467336261
• Email: yoann.cazaubon[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

• Patients on fractionated methadone (interferes with dosing during the study)

• 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

Related Conditions & MeSH terms

• Toxicomania

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak concentration (Cmax)	To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.	18 months
Secondary	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
Secondary	Residual concentration (C0)	To evaluate and estimate residual methadone/EDDP (metabolite) concentration for patients treated for opioid addiction.	18 months