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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic drug monitoring of methadone | Experimental | 6 samplings per subject: 3 venipunctures and 3 microsamplings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| C12h-24h concentration | To evaluate and estimate methadone/EDDP (metabolite) concentration between 12 and 24h post-administration for patients treated for opioid addiction. | 18 months |
| Residual concentration (C0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoann Cazaubon, phD,pharmD | Contact | +33467336261 | yoann.cazaubon@chu-montpellier.fr | |
| Hélène Donnadieu-Rigole, phD,MD | Contact | +33467337811 | h-donnadieu_rigole@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Yoann Cazaubon, phD,pharmD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Recruiting | Montpellier | France |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
To evaluate and estimate residual methadone/EDDP (metabolite) concentration for patients treated for opioid addiction.
| 18 months |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |