CHU de Montpellier
Montpellier, France
Location status: Recruiting
Recruiting
NCT Number: NCT05490732
Pharmacokinetic Modeling of Methadone
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–99 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Blood sampling
BiologicalPatient 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
Primary outcomes
-
Peak concentration (Cmax)
Time frame: 18 months
To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.
Secondary outcomes
-
C12h-24h concentration
Time frame: 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)
Time frame: 18 months
To evaluate and estimate residual methadone/EDDP (metabolite) concentration for patients treated for opioid addiction.
Study contacts
Contact information is provided by the study sponsor or research team.
Hélène Donnadieu-Rigole, phD,MD
CONTACT
Yoann Cazaubon, phD,pharmD
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Montpellier
Other
Registry information
Official study title
Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction
Acronym: PKMETHAHOME
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 8, 2022
- Registry last updated
- Nov 21, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.