Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT05490732
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2022-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Modeling of Methadone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak concentration (Cmax)', 'timeFrame': '18 months', 'description': 'To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.'}], 'secondaryOutcomes': [{'measure': 'C12h-24h concentration', 'timeFrame': '18 months', 'description': 'To evaluate and estimate methadone/EDDP (metabolite) concentration between 12 and 24h post-administration for patients treated for opioid addiction.'}, {'measure': 'Residual concentration (C0)', 'timeFrame': '18 months', 'description': 'To evaluate and estimate residual methadone/EDDP (metabolite) concentration for patients treated for opioid addiction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'methadone', 'microsampling', 'modeling'], 'conditions': ['Toxicomania']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patients on methadone on the same dosage for at least 7 days.\n* 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).\n* 24 hours monitoring is possible and accepted\n\nExclusion Criteria:\n\n* Patients that cannot be sampled because of weakened veins\n* Unable to received information about the study\n* Exclusion period determined by previous study\n* Adult protected by law or patient under guardianship\n* Not affiliated to french social security system\n* Not able to give written inform consent\n* Pregnant or breastfeeding woman\n* Underaged patients (under 18 years old)\n* Patient under court protection'}, 'identificationModule': {'nctId': 'NCT05490732', 'acronym': 'PKMETHAHOME', 'briefTitle': 'Pharmacokinetic Modeling of Methadone', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction', 'orgStudyIdInfo': {'id': '21_0614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic drug monitoring of methadone', 'description': '6 samplings per subject: 3 venipunctures and 3 microsamplings', 'interventionNames': ['Biological: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'otherNames': ['Volumetric absorptive microsampling'], 'description': 'Patient will be subjected to 3 blood sampling over 24hours. At H0, H4 and H12-24.\n\nFor each one, one microsampling and one venipuncture', 'armGroupLabels': ['Therapeutic drug monitoring of methadone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène Donnadieu, MD', 'role': 'CONTACT', 'email': 'h-donnadieu@chu-montpellier.fr', 'phone': '+33467338154'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Yoann Cazaubon, phD,pharmD', 'role': 'CONTACT', 'email': 'yoann.cazaubon@chu-montpellier.fr', 'phone': '+33467336261'}, {'name': 'Hélène Donnadieu-Rigole, phD,MD', 'role': 'CONTACT', 'email': 'h-donnadieu_rigole@chu-montpellier.fr', 'phone': '+33467337811'}], 'overallOfficials': [{'name': 'Yoann Cazaubon, phD,pharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}