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Recruiting NCT06589258

Cannabidiol Into Breastmilk

No phase Interventional Breast Feeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding.
Who it may be relevant to
Registry conditions: Breast Feeding. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding
    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 outcome measures

  • 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 [Time frame: Day 21 postpartum]
  • 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 [Time frame: Month 3 postpartum]
  • 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 [Time frame: Month 6 postpartum]
  • 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 [Time frame: Month 12 postpartum]
Secondary outcome measures (12)
  • Concentration of CBD in maternal blood [Time frame: Day 2 postpartum]
  • Concentration of CBD in maternal blood [Time frame: Day 21 postpartum]
  • Concentration of CBD in maternal blood [Time frame: Day 42 postpartum]
  • Concentration of CBD in maternal blood [Time frame: Month 3 postpartum]
  • Concentration of CBD in maternal blood [Time frame: Month 4 postpartum]
  • Concentration of CBD in maternal blood [Time frame: Month 6 postpartum]
  • Concentration of CBD in maternal blood [Time frame: Month 9 postpartum]
  • Concentration of CBD in maternal blood [Time frame: Month 12 postpartum]
  • Concentration of CBD metabolites in maternal blood [Time frame: Day 2 postpartum]
  • Concentration of CBD metabolites in maternal blood [Time frame: Day 21 postpartum]
  • Concentration of CBD metabolites in maternal blood [Time frame: Month 3 postpartum]
  • Concentration of CBD metabolites in maternal blood [Time frame: Month 4 postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU Orléans — Orléans

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06589258 · CHUO-2024-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗