CBD transfer into breast milk
Study of the Passage of (CBD) Into Breast Milk and Its Biological Impact on Breast-fed Children
NA · Centre Hospitalier Régional d'Orléans · NCT06589258
This project will test whether CBD used by breastfeeding mothers gets into their blood, breast milk, and their babies' urine.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Régional d'Orléans (other) |
| Locations | 1 site (Orléans) |
| Trial ID | NCT06589258 on ClinicalTrials.gov |
What this trial studies
Researchers at CHU Orléans will enroll breastfeeding women who currently use CBD and collect timed maternal blood and breast milk samples at different moments of lactation to measure CBD concentrations. Infant urine samples will also be collected to look for evidence of exposure. The protocol focuses on pharmacokinetic measurement of maternal and lactational CBD uptake rather than clinical outcomes and is run as a single-center interventional pharmacokinetic study. The aim is to quantify how much and when CBD transfers from mother to infant to inform safety guidance.
Who should consider this trial
Good fit: Breastfeeding women over 18 who currently use CBD, can give informed consent, speak French, and are registered with French social security.
Not a fit: Women who do not use CBD, cannot provide informed consent, do not understand French, are under legal guardianship, or lack French social security are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify how much CBD reaches breast-fed infants and help guide safer breastfeeding recommendations.
How similar studies have performed: Very few human data exist on CBD passage into breast milk, so this work is largely novel with limited prior evidence of similar results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women over 18 * Breastfeeding CBD user * Having given written informed consent 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
Where this trial is running
Orléans
- CHU Orléans — Orléans, France (RECRUITING)
Study contacts
- Principal investigator: Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr — CHU Orleans
- Study coordinator: Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr
- Email: marie-philippe.lebouchard-maakaroun@chu-orleans.fr
- Phone: +33238744181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Feeding, cannabidiol, Breast milk, Breast-feeding, Breast-feed children, PK POP