Cannabidiol Into Breastmilk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Feeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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breastfeeding mothers with CBD's consumption

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).

Group Type OTHER

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

Intervention Type 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).

Interventions

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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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No