NCT06589258

Cannabidiol Into Breastmilk

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Feeding

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2024-09-19
• Last updated: 2026-01-30

Locations

1 site across 1 country: France