Cannabidiol Into Breastmilk (CBD-ALLT)

Centre Hospitalier Régional d'Orléans

Status: Enrolling

Conditions: Breast Feeding

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06589258

CHUO-2024-02

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

breastfeeding mothers with CBD's consumption

Other group

Description:

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).

Treatment:

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