RecruitingNot ApplicableNCT06589258

Cannabidiol Into Breastmilk

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


Sponsor

Centre Hospitalier Régional d'Orléans

Enrollment

60 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria5

  • 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

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Interventions

BIOLOGICALAssessing 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

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NCT06589258


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