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RECRUITING
NCT06589258
NA

Cannabidiol Into Breastmilk

Sponsor: Centre Hospitalier Régional d'Orléans

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-06

Completion Date

2028-10

Last Updated

2026-01-30

Healthy Volunteers

No

Conditions

Interventions

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).

Locations (1)

CHU Orléans

Orléans, France