Cannabidiol Into Breastmilk

Not Applicable

Not yet recruiting

• Conditions: Breast Feeding
• Interventions: Biological: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding

• Registration Number: NCT06589258
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Study Start: 2025-03
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

• 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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
breastfeeding mothers with CBD's consumption	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 breast-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).

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Concentration of CBD in maternal blood	Month 12 postpartum
Concentration of CBD metabolites in maternal blood	Month 12 postpartum
Concentration of CBD in breast-milk	Month 12 postpartum
THC concentrations in mother's blood	Month 12 postpartum
THC concentrations in breast milk	Month 12 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine	Month 12 postpartum
THC/CBD ratio	Day 2 postpartum
Percentage of breastfeeding child with CBD in urine	Month 9 postpartum
Percentage of breastfeeding child with CBD metabolites in urine	Month 12 postpartum
impact of ethnicity	Day 2 postpartum
Percentage of breastfeeding mother's with CBD in urine	Month 3 postpartum
Percentage of breastfeeding mother's with THC in urine	Month 12 postpartum

Trial Locations

Locations (1)

CHU Orléans; 🇫🇷 Orléans, France