Cannabidiol Into Breastmilk
ConditionBreast Feeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Régional d'Orléans
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Women over 18
Breastfeeding CBD user
Having given written informed consent
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding
Biological/VaccineDetermination 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).
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: breastfeeding mothers with CBD's consumptionOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 2 postpartum2
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.
Time frame
Day 21 postpartum3
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.
Time frame
Day 42 postpartum4
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.
Time frame
Month 3 postpartumSecondary outcomes
1
Concentration of CBD in maternal blood
Time frame
Day 2 postpartum2
Concentration of CBD in maternal blood
Time frame
Day 21 postpartum3
Concentration of CBD in maternal blood
Time frame
Day 42 postpartum4
Concentration of CBD in maternal blood
Time frame
Month 3 postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov