Study of the Passage of Cannabidiol (CBD) Into Breast Milk and Its Biological Impact on Breast-fed Children

What this Trial Is About

Researchers are studying how cannabidiol (CBD) passes into breast milk and its potential biological impact on breast-fed infants. This study is important because there is little data on CBD passage through breast milk and its effects on babies, despite many women of childbearing age consuming CBD in France. The study aims to measure CBD levels in maternal blood and breast milk at various postpartum times and detect CBD in infants' urine to understand potential exposure. The study involves assessing the presence of CBD and its metabolites, as well as delta 9-tetrahydrocannabinol (THC) and its metabolites, using advanced liquid chromatography-tandem mass spectrometry (LC-MS/MS). Researchers will calculate the THC/CBD ratio and perform qualitative tests for cannabinoids in urine samples from both mothers and their breast-fed children. Measurements will be taken at multiple postpartum time points including days 2, 21, 42, and months 3, 4, 6, 9, and 12. Participants will provide blood, breast milk, and urine samples at these scheduled times to allow researchers to track CBD concentration and estimated infant exposure over time. The study evaluates the theoretical doses of CBD received by infants over 24 hours at each postpartum stage. Safety and exposure data will be monitored throughout the one-year postpartum period to better understand CBD transfer during breastfeeding.

Cannabidiol Into Breastmilk