CBD transfer into breast milk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.