Pharmacokinetic Modeling of Methadone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-23

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Toxicomania

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Therapeutic drug monitoring of methadone

6 samplings per subject: 3 venipunctures and 3 microsamplings

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

Patient will be subjected to 3 blood sampling over 24hours. At H0, H4 and H12-24.

For each one, one microsampling and one venipuncture

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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Volumetric absorptive microsampling

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No