Toxicomania
Conditions
Keywords
pharmacokinetics, methadone, microsampling, modeling
Brief 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.
Interventions
BIOLOGICALBlood 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
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak concentration (Cmax) | 18 months | To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C12h-24h concentration | 18 months | To evaluate and estimate methadone/EDDP (metabolite) concentration between 12 and 24h post-administration for patients treated for opioid addiction. |
| Residual concentration (C0) | 18 months | To evaluate and estimate residual methadone/EDDP (metabolite) concentration for patients treated for opioid addiction. |
Countries
France
Contacts
Primary ContactYoann Cazaubon, phD,pharmD
Backup ContactHélène Donnadieu-Rigole, phD,MD
Outcome results
None listed