Addiction Medicine Physicians and Medicinal Cannabinoids.
Marc N Potenza, Gregory Bunt, Jag H Khalsa
https://pubmed.ncbi.nlm.nih.gov/37133830/Actively Recruiting
Led by Centre Hospitalier Régional d'Orléans · Updated on 2026-01-30
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
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-MSMS. Researchers will calculate the THCCBD 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.
CONDITIONS
Cannabidiol Into Breastmilk
M
Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr
E
Elodie POUGOUE
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Centre Hospitalier Régional d'Orléans
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months postpartum
Participants have blood and breastmilk samples collected at multiple time points postpartum to assess cannabidiol (CBD), THC, and their metabolites. Urine samples from mothers and breast-fed children are also collected to detect cannabinoids.
Approximately 8 visits at Day 2, Day 21, Day 42, and Months 3, 4, 6, 9, and 12 postpartum
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Lead Sponsor