Cannabidiol Into Breastmilk

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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

Primary outcome measure(s)

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

Trial sites (1)

More Centre Hospitalier Régional d'Orléans trials in France