Cannabidiol Into Breastmilk

NCT06589258 | Recruiting

• 1 other identifier: CHUO-2024-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Feeding

Keywords

cannabidiol; Breast milk; Breast-feeding; Breast-feed children; PK POP

Outcome Measures

Primary Outcomes (8)

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

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

  Day 2 postpartum

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

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

  Day 21 postpartum

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

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

  Day 42 postpartum

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

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

  Month 3 postpartum

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

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

  Month 4 postpartum

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

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

  Month 6 postpartum

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

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

  Month 9 postpartum

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

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

  Month 12 postpartum

Secondary Outcomes (79)

• Concentration of CBD in maternal blood

  Day 2 postpartum

• Concentration of CBD in maternal blood

  Day 21 postpartum

• Concentration of CBD in maternal blood

  Day 42 postpartum

• Concentration of CBD in maternal blood

  Month 3 postpartum

• Concentration of CBD in maternal blood

  Month 4 postpartum

Study Arms (1)

breastfeeding mothers with CBD's consumption

OTHER

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

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

Interventions

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).

breastfeeding mothers with CBD's consumption

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18
• Breastfeeding CBD user
• Having given written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU Orléans

Orléans, France

RECRUITING

Related Publications (7)

• Kessler FH, von Diemen L, Ornell F, Sordi AO. Cannabidiol and mental health: possibilities, uncertainties, and controversies for addiction treatment. Braz J Psychiatry. 2021 Sep-Oct;43(5):455-457. doi: 10.1590/1516-4446-2021-1838. No abstract available.

  PMID: 34008796 BACKGROUND

• Costentin J. [Epigenetic effects of cannabis/tetrahydrocannabinol]. Bull Acad Natl Med. 2020 Jun;204(6):570-576. doi: 10.1016/j.banm.2020.04.004. Epub 2020 Apr 15. French.

  PMID: 32296244 BACKGROUND

• Potenza MN, Bunt G, Khalsa JH. Addiction Medicine Physicians and Medicinal Cannabinoids. JAMA Psychiatry. 2023 Jul 1;80(7):659-660. doi: 10.1001/jamapsychiatry.2023.0731.

  PMID: 37133830 BACKGROUND

• Johnson CT, Bradshaw HB. Modulatory Potential of Cannabidiol on the Opioid-Induced Inflammatory Response. Cannabis Cannabinoid Res. 2021 Jun;6(3):211-220. doi: 10.1089/can.2020.0181.

  PMID: 34115948 BACKGROUND

• Batalla A, Janssen H, Gangadin SS, Bossong MG. The Potential of Cannabidiol as a Treatment for Psychosis and Addiction: Who Benefits Most? A Systematic Review. J Clin Med. 2019 Jul 19;8(7):1058. doi: 10.3390/jcm8071058.

  PMID: 31330972 BACKGROUND

• Hurd YL, Yoon M, Manini AF, Hernandez S, Olmedo R, Ostman M, Jutras-Aswad D. Early Phase in the Development of Cannabidiol as a Treatment for Addiction: Opioid Relapse Takes Initial Center Stage. Neurotherapeutics. 2015 Oct;12(4):807-15. doi: 10.1007/s13311-015-0373-7.

  PMID: 26269227 BACKGROUND

• Paulus V, Billieux J, Benyamina A, Karila L. Cannabidiol in the context of substance use disorder treatment: A systematic review. Addict Behav. 2022 Sep;132:107360. doi: 10.1016/j.addbeh.2022.107360. Epub 2022 May 7.

  PMID: 35580370 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr

  CHU Orleans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr

CONTACT

+33238744181; marie-philippe.lebouchard-maakaroun@chu-orleans.fr

Elodie POUGOUE

CONTACT

+33238744086; elodie.pougoue-touko@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of sixty breastfeeding mothers with CBD's consumption Two subgroups: thirty subjects by group: * only CBD intake * CBD and others psychoactive substances

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

FR (1)