Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06589258

Cannabidiol Into Breastmilk

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Orléans

Orléans, France

Location status: Recruiting

Location contact

Marie-Philippe LEBOUCHARD-MAAKAROUN

PRINCIPAL_INVESTIGATOR

Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding

Biological

Determination of delta 9-tetrahydrocannabinol (THC) and its metabolites , and of cannabidiol and its metabolites in blood and breasts-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 outcomes

  1. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: Day 2 postpartum

    Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.

  2. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: Day 21 postpartum

    Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.

  3. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: Day 42 postpartum

    Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.

  4. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: Month 3 postpartum

    Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.

  5. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: Month 4 postpartum

    Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.

  6. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: Month 6 postpartum

    Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.

  7. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: Month 9 postpartum

    Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.

  8. Theoretical dose of CBD received by the breastfed child over 24 hours

    Time frame: 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 outcomes

  1. Concentration of CBD in maternal blood

    Time frame: Day 2 postpartum

  2. Concentration of CBD in maternal blood

    Time frame: Day 21 postpartum

  3. Concentration of CBD in maternal blood

    Time frame: Day 42 postpartum

  4. Concentration of CBD in maternal blood

    Time frame: Month 3 postpartum

  5. Concentration of CBD in maternal blood

    Time frame: Month 4 postpartum

  6. Concentration of CBD in maternal blood

    Time frame: Month 6 postpartum

  7. Concentration of CBD in maternal blood

    Time frame: Month 9 postpartum

  8. Concentration of CBD in maternal blood

    Time frame: Month 12 postpartum

  9. Concentration of CBD metabolites in maternal blood

    Time frame: Day 2 postpartum

  10. Concentration of CBD metabolites in maternal blood

    Time frame: Day 21 postpartum

  11. Concentration of CBD metabolites in maternal blood

    Time frame: Month 3 postpartum

  12. Concentration of CBD metabolites in maternal blood

    Time frame: Month 4 postpartum

  13. Concentration of CBD metabolites in maternal blood

    Time frame: Month 6 postpartum

  14. Concentration of CBD metabolites in maternal blood

    Time frame: Month 9 postpartum

  15. Concentration of CBD metabolites in maternal blood

    Time frame: Month 12 postpartum

  16. Concentration of CBD in breast-milk

    Time frame: Day 2 postpartum

  17. Concentration of CBD in breast-milk

    Time frame: Day 21 postpartum

  18. Concentration of CBD in breast-milk

    Time frame: Day 42 postpartum

  19. Concentration of CBD in breast-milk

    Time frame: Month 3 postpartum

  20. Concentration of CBD in breast-milk

    Time frame: Month 4 postpartum

  21. Concentration of CBD in breast-milk

    Time frame: Month 6 postpartum

  22. Concentration of CBD in breast-milk

    Time frame: Month 9 postpartum

  23. Concentration of CBD in breast-milk

    Time frame: Month 12 postpartum

  24. THC concentrations in mother's blood

    Time frame: Day 2 postpartum

  25. THC concentrations in mother's blood

    Time frame: Day 21 postpartum

  26. THC concentrations in mother's blood

    Time frame: Day 42 postpartum

  27. THC concentrations in mother's blood

    Time frame: Month 3 postpartum

  28. THC concentrations in mother's blood

    Time frame: Month 4 postpartum

  29. THC concentrations in mother's blood

    Time frame: Month 6 postpartum

  30. THC concentrations in mother's blood

    Time frame: Month 9 postpartum

  31. THC concentrations in mother's blood

    Time frame: Month 12 postpartum

  32. THC concentrations in breast milk

    Time frame: Day 2 postpartum

  33. THC concentrations in breast milk

    Time frame: Day 21 postpartum

  34. THC concentrations in breast milk

    Time frame: Day 42 postpartum

  35. THC concentrations in breast milk

    Time frame: Month 3 postpartum

  36. THC concentrations in breast milk

    Time frame: Month 4 postpartum

  37. THC concentrations in breast milk

    Time frame: Month 6 postpartum

  38. THC concentrations in breast milk

    Time frame: Month 9 postpartum

  39. THC concentrations in breast milk

    Time frame: Month 12 postpartum

  40. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Day 2 postpartum

  41. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Day 21 postpartum

  42. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Day 42 postpartum

  43. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Month 3 postpartum

  44. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Month 4 postpartum

  45. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Month 6 postpartum

  46. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Month 9 postpartum

  47. THC/CBD ratio

    Time frame: Day 2 postpartum

  48. Percentage of breastfeeding child with CBD in urine

    Time frame: Day 2 postpartum

  49. Percentage of breastfeeding child with CBD in urine

    Time frame: Day 21 postpartum

  50. Percentage of breastfeeding child with CBD in urine

    Time frame: Day 42 postpartum

  51. Percentage of breastfeeding child with CBD in urine

    Time frame: Month 3 postpartum

  52. Percentage of breastfeeding child with CBD in urine

    Time frame: Month 4 postpartum

  53. Percentage of breastfeeding child with CBD in urine

    Time frame: Month 6 postpartum

  54. Percentage of breastfeeding child with CBD in urine

    Time frame: Month 9 postpartum

  55. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Day 2 postpartum

  56. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Day 21 postpartum

  57. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Day 42 postpartum

  58. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Month 3 postpartum

  59. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Month 4 postpartum

  60. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Month 6 postpartum

  61. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Month 9 postpartum

  62. impact of ethnicity

    Time frame: Day 2 postpartum

  63. Percentage of breastfeeding mother's with CBD in urine

    Time frame: Day 2 postpartum

  64. Percentage of breastfeeding mother's with CBD in urine

    Time frame: Day 21 postpartum

  65. Percentage of breastfeeding mother's with CBD in urine

    Time frame: Day 42 postpartum

  66. Percentage of breastfeeding mother's with CBD in urine

    Time frame: Month 4 postpartum

  67. Percentage of breastfeeding mother's with CBD in urine

    Time frame: Month 6 postpartum

  68. Percentage of breastfeeding mother's with CBD metabolites in urine

    Time frame: Month 12 postpartum

  69. Percentage of breastfeeding mother's with CBD in urine

    Time frame: Month 12 postpartum

  70. Percentage of breastfeeding mother's with CBD in urine

    Time frame: Month 3 postpartum

  71. Percentage of breastfeeding child with CBD metabolites in urine

    Time frame: Month 12 postpartum

  72. Percentage of breastfeeding mother's with THC in urine

    Time frame: Day 2 postpartum

  73. Percentage of breastfeeding mother's with THC in urine

    Time frame: Day 21 postpartum

  74. Percentage of breastfeeding mother's with THC in urine

    Time frame: Day 42 postpartum

  75. Percentage of breastfeeding mother's with THC in urine

    Time frame: Month 3 postpartum

  76. Percentage of breastfeeding mother's with THC in urine

    Time frame: Month 4 postpartum

  77. Percentage of breastfeeding mother's with THC in urine

    Time frame: Month 6 postpartum

  78. Percentage of breastfeeding mother's with THC in urine

    Time frame: Month 9 postpartum

  79. Percentage of breastfeeding mother's with THC in urine

    Time frame: Month 12 postpartum

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie POUGOUE

CONTACT

[email protected]

+33238744086

Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr

CONTACT

[email protected]

+33238744181

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: CBD-ALLT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.