Clinical trial NCT06589258: Cannabidiol Into Breastmilk
Official title: Study of the Passage of (CBD) Into Breast Milk and Its Biological Impact on Breast-fed Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Feeding
Keywords: cannabidiol
Breast milk
Breast-feeding
Breast-feed children
PK POP
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group of sixty breastfeeding mothers with CBD's consumption

Two subgroups: thirty subjects by group:

* only CBD intake
* CBD and others psychoactive substances
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Day 2 postpartum
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Day 21 postpartum
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Day 42 postpartum
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Month 3 postpartum
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Month 4 postpartum
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Month 6 postpartum
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Month 9 postpartum
measure: Theoretical dose of CBD received by the breastfed child over 24 hours
timeFrame: Month 12 postpartum
Secondary outcomes:
measure: Concentration of CBD in maternal blood
timeFrame: Day 2 postpartum
measure: Concentration of CBD in maternal blood
timeFrame: Day 21 postpartum
measure: Concentration of CBD in maternal blood
timeFrame: Day 42 postpartum
measure: Concentration of CBD in maternal blood
timeFrame: Month 3 postpartum
measure: Concentration of CBD in maternal blood
timeFrame: Month 4 postpartum
measure: Concentration of CBD in maternal blood
timeFrame: Month 6 postpartum
measure: Concentration of CBD in maternal blood
timeFrame: Month 9 postpartum
measure: Concentration of CBD in maternal blood
timeFrame: Month 12 postpartum
measure: Concentration of CBD metabolites in maternal blood
timeFrame: Day 2 postpartum
measure: Concentration of CBD metabolites in maternal blood
timeFrame: Day 21 postpartum
measure: Concentration of CBD metabolites in maternal blood
timeFrame: Month 3 postpartum
measure: Concentration of CBD metabolites in maternal blood
timeFrame: Month 4 postpartum
measure: Concentration of CBD metabolites in maternal blood
timeFrame: Month 6 postpartum
measure: Concentration of CBD metabolites in maternal blood
timeFrame: Month 9 postpartum
measure: Concentration of CBD metabolites in maternal blood
timeFrame: Month 12 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Day 2 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Day 21 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Day 42 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Month 3 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Month 4 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Month 6 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Month 9 postpartum
measure: Concentration of CBD in breast-milk
timeFrame: Month 12 postpartum
measure: THC concentrations in mother's blood
timeFrame: Day 2 postpartum
measure: THC concentrations in mother's blood
timeFrame: Day 21 postpartum
measure: THC concentrations in mother's blood
timeFrame: Day 42 postpartum
measure: THC concentrations in mother's blood
timeFrame: Month 3 postpartum
measure: THC concentrations in mother's blood
timeFrame: Month 4 postpartum
measure: THC concentrations in mother's blood
timeFrame: Month 6 postpartum
measure: THC concentrations in mother's blood
timeFrame: Month 9 postpartum
measure: THC concentrations in mother's blood
timeFrame: Month 12 postpartum
measure: THC concentrations in breast milk
timeFrame: Day 2 postpartum
measure: THC concentrations in breast milk
timeFrame: Day 21 postpartum
measure: THC concentrations in breast milk
timeFrame: Day 42 postpartum
measure: THC concentrations in breast milk
timeFrame: Month 3 postpartum
measure: THC concentrations in breast milk
timeFrame: Month 4 postpartum
measure: THC concentrations in breast milk
timeFrame: Month 6 postpartum
measure: THC concentrations in breast milk
timeFrame: Month 9 postpartum
measure: THC concentrations in breast milk
timeFrame: Month 12 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Day 2 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Day 21 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Day 42 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Month 3 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Month 4 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Month 6 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Month 9 postpartum
measure: THC/CBD ratio
timeFrame: Day 2 postpartum
measure: Percentage of breastfeeding child with CBD in urine
timeFrame: Day 2 postpartum
measure: Percentage of breastfeeding child with CBD in urine
timeFrame: Day 21 postpartum
measure: Percentage of breastfeeding child with CBD in urine
timeFrame: Day 42 postpartum
measure: Percentage of breastfeeding child with CBD in urine
timeFrame: Month 3 postpartum
measure: Percentage of breastfeeding child with CBD in urine
timeFrame: Month 4 postpartum
measure: Percentage of breastfeeding child with CBD in urine
timeFrame: Month 6 postpartum
measure: Percentage of breastfeeding child with CBD in urine
timeFrame: Month 9 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Day 2 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Day 21 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Day 42 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Month 3 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Month 4 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Month 6 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Month 9 postpartum
measure: impact of ethnicity
timeFrame: Day 2 postpartum
measure: Percentage of breastfeeding mother's with CBD in urine
timeFrame: Day 2 postpartum
measure: Percentage of breastfeeding mother's with CBD in urine
timeFrame: Day 21 postpartum
measure: Percentage of breastfeeding mother's with CBD in urine
timeFrame: Day 42 postpartum
measure: Percentage of breastfeeding mother's with CBD in urine
timeFrame: Month 4 postpartum
measure: Percentage of breastfeeding mother's with CBD in urine
timeFrame: Month 6 postpartum
measure: Percentage of breastfeeding mother's with CBD metabolites in urine
timeFrame: Month 12 postpartum
measure: Percentage of breastfeeding mother's with CBD in urine
timeFrame: Month 12 postpartum
measure: Percentage of breastfeeding mother's with CBD in urine
timeFrame: Month 3 postpartum
measure: Percentage of breastfeeding child with CBD metabolites in urine
timeFrame: Month 12 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Day 2 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Day 21 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Day 42 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Month 3 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Month 4 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Month 6 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Month 9 postpartum
measure: Percentage of breastfeeding mother's with THC in urine
timeFrame: Month 12 postpartum
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHU Orléans
Study officials:
affiliation: CHU Orleans
name: Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.