Modeling how methadone works in the body for opioid addiction treatment
Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction
This study is testing a new way to understand how methadone works in the body to help people with opioid addiction get the right dose and feel better faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05490732 on ClinicalTrials.gov |
What this trial studies
This study aims to create a pharmacokinetic model for methadone to better manage opioid addiction. By understanding the variability in how patients metabolize methadone, the study seeks to optimize dosages and reduce withdrawal periods. The approach involves blood sampling to monitor plasma concentrations, allowing for more personalized treatment plans. The goal is to empower patients by providing them with information about their blood levels and improving overall treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults on a stable methadone dosage for at least 7 days who are hospitalized for withdrawal management.
Not a fit: Patients with weakened veins, those unable to provide informed consent, or individuals under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment for patients struggling with opioid addiction.
How similar studies have performed: While few population pharmacokinetic models for methadone exist, this approach is relatively novel and has not been extensively tested in the context of opioid addiction management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- CHU de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Yoann Cazaubon, phD,pharmD — University Hospital, Montpellier
- Study coordinator: Yoann Cazaubon, phD,pharmD
- Email: yoann.cazaubon@chu-montpellier.fr
- Phone: +33467336261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.