Pharmacokinetic Modeling of Methadone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling.
- Who it may be relevant to
- Registry conditions: Toxicomania. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction
Overview
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.
Interventions
- 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
Primary outcome measures
- Peak concentration (Cmax) [Time frame: 18 months]
Secondary outcome measures (2)
- C12h-24h concentration [Time frame: 18 months]
- Residual concentration (C0) [Time frame: 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- CHU de Montpellier — Montpellier
Identifiers
NCT: NCT05490732 · 21_0614