Cannabidiol Into Breastmilk (CBD-ALLT)

Study of the Passage of (CBD) Into Breast Milk and Its Biological Impact on Breast-fed Children

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Feeding
• Intervention / Treatment: Biological: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elodie Pougoue; Phone Number: +33238744086; Email: elodie.pougoue-touko@chu-orleans.fr
• Study Contact Backup: Name: Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr; Phone Number: +33238744181; Email: marie-philippe.lebouchard-maakaroun@chu-orleans.fr

Study Locations

• France
  • Orléans, France
    • Recruiting
    • CHU Orléans
    • Contact: Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr; Email: marie-philippe.lebouchard-maakaroun@chu-orleans.fr
    • Principal Investigator: Marie-Philippe LEBOUCHARD-MAAKAROUN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women over 18
• Breastfeeding CBD user
• Having given written informed consent

Exclusion Criteria:

• Women who do not understand French well
• Women with a psychiatric or dual pathology that prevents proper participation in the study,
• Women under protective supervision (guardianship/curatorship),
• Women under court protection,
• Women not affiliated to a social security scheme

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: breastfeeding mothers with CBD's consumption; 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).

Biological: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Day 2 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Day 21 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Day 42 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Month 3 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Month 4 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Month 6 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Month 9 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours	Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.	Month 12 postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
Concentration of CBD in maternal blood	Day 2 postpartum
Concentration of CBD in maternal blood	Day 21 postpartum
Concentration of CBD in maternal blood	Day 42 postpartum
Concentration of CBD in maternal blood	Month 3 postpartum
Concentration of CBD in maternal blood	Month 4 postpartum
Concentration of CBD in maternal blood	Month 6 postpartum
Concentration of CBD in maternal blood	Month 9 postpartum
Concentration of CBD in maternal blood	Month 12 postpartum
Concentration of CBD metabolites in maternal blood	Day 2 postpartum
Concentration of CBD metabolites in maternal blood	Day 21 postpartum
Concentration of CBD metabolites in maternal blood	Month 3 postpartum
Concentration of CBD metabolites in maternal blood	Month 4 postpartum
Concentration of CBD metabolites in maternal blood	Month 6 postpartum
Concentration of CBD metabolites in maternal blood	Month 9 postpartum
Concentration of CBD metabolites in maternal blood	Month 12 postpartum
Concentration of CBD in breast-milk	Day 2 postpartum
Concentration of CBD in breast-milk	Day 21 postpartum
Concentration of CBD in breast-milk	Day 42 postpartum
Concentration of CBD in breast-milk	Month 3 postpartum
Concentration of CBD in breast-milk	Month 4 postpartum
Concentration of CBD in breast-milk	Month 6 postpartum
Concentration of CBD in breast-milk	Month 9 postpartum
Concentration of CBD in breast-milk	Month 12 postpartum
THC concentrations in mother's blood	Day 2 postpartum
THC concentrations in mother's blood	Day 21 postpartum
THC concentrations in mother's blood	Day 42 postpartum
THC concentrations in mother's blood	Month 3 postpartum
THC concentrations in mother's blood	Month 4 postpartum
THC concentrations in mother's blood	Month 6 postpartum
THC concentrations in mother's blood	Month 9 postpartum
THC concentrations in mother's blood	Month 12 postpartum
THC concentrations in breast milk	Day 2 postpartum
THC concentrations in breast milk	Day 21 postpartum
THC concentrations in breast milk	Day 42 postpartum
THC concentrations in breast milk	Month 3 postpartum
THC concentrations in breast milk	Month 4 postpartum
THC concentrations in breast milk	Month 6 postpartum
THC concentrations in breast milk	Month 9 postpartum
THC concentrations in breast milk	Month 12 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Day 2 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Day 21 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Day 42 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Month 3 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Month 4 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Month 6 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Month 9 postpartum
THC/CBD ratio	Day 2 postpartum
Percentage of breastfeeding child with CBD in urine	Day 2 postpartum
Percentage of breastfeeding child with CBD in urine	Day 21 postpartum
Percentage of breastfeeding child with CBD in urine	Day 42 postpartum
Percentage of breastfeeding child with CBD in urine	Month 3 postpartum
Percentage of breastfeeding child with CBD in urine	Month 4 postpartum
Percentage of breastfeeding child with CBD in urine	Month 6 postpartum
Percentage of breastfeeding child with CBD in urine	Month 9 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Day 2 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Day 21 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Day 42 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Month 3 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Month 4 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Month 6 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Month 9 postpartum
impact of ethnicity	Day 2 postpartum
Percentage of breastfeeding mother's with CBD in urine	Day 2 postpartum
Percentage of breastfeeding mother's with CBD in urine	Day 21 postpartum
Percentage of breastfeeding mother's with CBD in urine	Day 42 postpartum
Percentage of breastfeeding mother's with CBD in urine	Month 4 postpartum
Percentage of breastfeeding mother's with CBD in urine	Month 6 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Month 12 postpartum
Percentage of breastfeeding mother's with CBD in urine	Month 12 postpartum
Percentage of breastfeeding mother's with CBD in urine	Month 3 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Month 12 postpartum
Percentage of breastfeeding mother's with THC in urine	Day 2 postpartum
Percentage of breastfeeding mother's with THC in urine	Day 21 postpartum
Percentage of breastfeeding mother's with THC in urine	Day 42 postpartum
Percentage of breastfeeding mother's with THC in urine	Month 3 postpartum
Percentage of breastfeeding mother's with THC in urine	Month 4 postpartum
Percentage of breastfeeding mother's with THC in urine	Month 6 postpartum
Percentage of breastfeeding mother's with THC in urine	Month 9 postpartum
Percentage of breastfeeding mother's with THC in urine	Month 12 postpartum

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr, CHU Orléans

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cannabidiol; Breast milk; Breast-feeding; Breast-feed children; PK POP
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: CHUO-2024-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No