Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-24 @ 5:51 AM
Study NCT ID:
NCT06589258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabidiol Into Breastmilk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "One group of sixty breastfeeding mothers with CBD's consumption\n\nTwo subgroups: thirty subjects by group:\n\n* only CBD intake\n* CBD and others psychoactive substances"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Day 2 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}, {'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Day 21 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}, {'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Day 42 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}, {'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Month 3 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}, {'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Month 4 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}, {'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Month 6 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}, {'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Month 9 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}, {'measure': 'Theoretical dose of CBD received by the breastfed child over 24 hours', 'timeFrame': 'Month 12 postpartum', 'description': 'Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.'}], 'secondaryOutcomes': [{'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Day 2 postpartum'}, {'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Day 21 postpartum'}, {'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Day 42 postpartum'}, {'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Month 3 postpartum'}, {'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Month 4 postpartum'}, {'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Month 6 postpartum'}, {'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Month 9 postpartum'}, {'measure': 'Concentration of CBD in maternal blood', 'timeFrame': 'Month 12 postpartum'}, {'measure': 'Concentration of CBD metabolites in maternal blood', 'timeFrame': 'Day 2 postpartum'}, {'measure': 'Concentration of CBD metabolites in maternal blood', 'timeFrame': 'Day 21 postpartum'}, {'measure': 'Concentration of CBD metabolites in maternal blood', 'timeFrame': 'Month 3 postpartum'}, {'measure': 'Concentration of CBD metabolites in maternal blood', 'timeFrame': 'Month 4 postpartum'}, {'measure': 'Concentration of CBD metabolites in maternal blood', 'timeFrame': 'Month 6 postpartum'}, {'measure': 'Concentration of CBD metabolites in maternal blood', 'timeFrame': 'Month 9 postpartum'}, {'measure': 'Concentration of CBD metabolites in maternal blood', 'timeFrame': 'Month 12 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Day 2 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Day 21 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Day 42 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Month 3 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Month 4 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Month 6 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Month 9 postpartum'}, {'measure': 'Concentration of CBD in breast-milk', 'timeFrame': 'Month 12 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Day 2 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Day 21 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Day 42 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Month 3 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Month 4 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Month 6 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Month 9 postpartum'}, {'measure': "THC concentrations in mother's blood", 'timeFrame': 'Month 12 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Day 2 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Day 21 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Day 42 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Month 3 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Month 4 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Month 6 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Month 9 postpartum'}, {'measure': 'THC concentrations in breast milk', 'timeFrame': 'Month 12 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Day 2 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Day 21 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Day 42 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Month 3 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Month 4 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Month 6 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Month 9 postpartum'}, {'measure': 'THC/CBD ratio', 'timeFrame': 'Day 2 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD in urine', 'timeFrame': 'Day 2 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD in urine', 'timeFrame': 'Day 21 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD in urine', 'timeFrame': 'Day 42 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD in urine', 'timeFrame': 'Month 3 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD in urine', 'timeFrame': 'Month 4 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD in urine', 'timeFrame': 'Month 6 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD in urine', 'timeFrame': 'Month 9 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Day 2 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Day 21 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Day 42 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Month 3 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Month 4 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Month 6 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Month 9 postpartum'}, {'measure': 'impact of ethnicity', 'timeFrame': 'Day 2 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD in urine", 'timeFrame': 'Day 2 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD in urine", 'timeFrame': 'Day 21 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD in urine", 'timeFrame': 'Day 42 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD in urine", 'timeFrame': 'Month 4 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD in urine", 'timeFrame': 'Month 6 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD metabolites in urine", 'timeFrame': 'Month 12 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD in urine", 'timeFrame': 'Month 12 postpartum'}, {'measure': "Percentage of breastfeeding mother's with CBD in urine", 'timeFrame': 'Month 3 postpartum'}, {'measure': 'Percentage of breastfeeding child with CBD metabolites in urine', 'timeFrame': 'Month 12 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Day 2 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Day 21 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Day 42 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Month 3 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Month 4 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Month 6 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Month 9 postpartum'}, {'measure': "Percentage of breastfeeding mother's with THC in urine", 'timeFrame': 'Month 12 postpartum'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cannabidiol', 'Breast milk', 'Breast-feeding', 'Breast-feed children', 'PK POP'], 'conditions': ['Breast Feeding']}, 'referencesModule': {'references': [{'pmid': '34008796', 'type': 'BACKGROUND', 'citation': 'Kessler FH, von Diemen L, Ornell F, Sordi AO. Cannabidiol and mental health: possibilities, uncertainties, and controversies for addiction treatment. Braz J Psychiatry. 2021 Sep-Oct;43(5):455-457. doi: 10.1590/1516-4446-2021-1838. No abstract available.'}, {'pmid': '32296244', 'type': 'BACKGROUND', 'citation': 'Costentin J. [Epigenetic effects of cannabis/tetrahydrocannabinol]. Bull Acad Natl Med. 2020 Jun;204(6):570-576. doi: 10.1016/j.banm.2020.04.004. Epub 2020 Apr 15. French.'}, {'pmid': '37133830', 'type': 'BACKGROUND', 'citation': 'Potenza MN, Bunt G, Khalsa JH. Addiction Medicine Physicians and Medicinal Cannabinoids. JAMA Psychiatry. 2023 Jul 1;80(7):659-660. doi: 10.1001/jamapsychiatry.2023.0731.'}, {'pmid': '34115948', 'type': 'BACKGROUND', 'citation': 'Johnson CT, Bradshaw HB. Modulatory Potential of Cannabidiol on the Opioid-Induced Inflammatory Response. Cannabis Cannabinoid Res. 2021 Jun;6(3):211-220. doi: 10.1089/can.2020.0181.'}, {'pmid': '31330972', 'type': 'BACKGROUND', 'citation': 'Batalla A, Janssen H, Gangadin SS, Bossong MG. The Potential of Cannabidiol as a Treatment for Psychosis and Addiction: Who Benefits Most? A Systematic Review. J Clin Med. 2019 Jul 19;8(7):1058. doi: 10.3390/jcm8071058.'}, {'pmid': '26269227', 'type': 'BACKGROUND', 'citation': 'Hurd YL, Yoon M, Manini AF, Hernandez S, Olmedo R, Ostman M, Jutras-Aswad D. Early Phase in the Development of Cannabidiol as a Treatment for Addiction: Opioid Relapse Takes Initial Center Stage. Neurotherapeutics. 2015 Oct;12(4):807-15. doi: 10.1007/s13311-015-0373-7.'}, {'pmid': '35580370', 'type': 'BACKGROUND', 'citation': 'Paulus V, Billieux J, Benyamina A, Karila L. Cannabidiol in the context of substance use disorder treatment: A systematic review. Addict Behav. 2022 Sep;132:107360. doi: 10.1016/j.addbeh.2022.107360. Epub 2022 May 7.'}]}, 'descriptionModule': {'briefSummary': "Really few data published to date on the passage of CBD into breast milk. The investigators known that 17.5 percent of the French human being between 18 and 34 years old consume CBD and among this, nearly half are women. None official French data to say how many French breastfeeding mothers consume CBD. CBD is a legal, psychoactive but not psychoaddictive substance. CBD's pharmacokinetic and pharmacodynamics make us fear that CBD could easily go through mother's milk. No published data available on possible effect in breast-fed child, not even on possible biological passage in breast-fed child. The aim of his study is to evaluate the passage of CBD in blood and milk at different moments of the breastfeeding (mothers) and its possible found in the infants'urine."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women over 18\n* Breastfeeding CBD user\n* Having given written informed consent\n\nExclusion Criteria:\n\n* Women who do not understand French well\n* Women with a psychiatric or dual pathology that prevents proper participation in the study,\n* Women under protective supervision (guardianship/curatorship),\n* Women under court protection,\n* Women not affiliated to a social security scheme'}, 'identificationModule': {'nctId': 'NCT06589258', 'acronym': 'CBD-ALLT', 'briefTitle': 'Cannabidiol Into Breastmilk', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier Régional d'Orléans"}, 'officialTitle': 'Study of the Passage of (CBD) Into Breast Milk and Its Biological Impact on Breast-fed Children', 'orgStudyIdInfo': {'id': 'CHUO-2024-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "breastfeeding mothers with CBD's consumption", 'description': "Determination of delta 9-tetrahydrocannabinol (THC) and its metabolites , and of cannabidiol and its metabolites in blood and breast-milk by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Realization of THC/CBD ratio; qualitative research in mother's and breast-fed child's urine for the presence of cannabinoids (THC, CBD and its metabolites).", 'interventionNames': ['Biological: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding']}], 'interventions': [{'name': 'Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding', 'type': 'BIOLOGICAL', 'description': "Determination of delta 9-tetrahydrocannabinol (THC) and its metabolites , and of cannabidiol and its metabolites in blood and breasts-milk by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Realization of THC/CBD ratio; qualitative research in mother's and breast-fed child's urine for the presence of cannabinoids (THC, CBD and its metabolites).", 'armGroupLabels': ["breastfeeding mothers with CBD's consumption"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Orléans', 'country': 'France', 'contacts': [{'name': 'Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr', 'role': 'CONTACT', 'email': 'marie-philippe.lebouchard-maakaroun@chu-orleans.fr'}, {'name': 'Marie-Philippe LEBOUCHARD-MAAKAROUN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Orléans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}], 'centralContacts': [{'name': 'Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr', 'role': 'CONTACT', 'email': 'marie-philippe.lebouchard-maakaroun@chu-orleans.fr', 'phone': '+33238744181'}, {'name': 'Elodie POUGOUE', 'role': 'CONTACT', 'email': 'elodie.pougoue-touko@chu-orleans.fr', 'phone': '+33238744086'}], 'overallOfficials': [{'name': 'Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Orleans'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier Régional d'Orléans", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}