Cannabidiol Into Breastmilk (CBD-ALLT)

January 29, 2026 updated by: Centre Hospitalier Régional d'Orléans

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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).
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: Day 21 postpartum
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
Time Frame: Day 42 postpartum
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
Time Frame: Month 3 postpartum
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
Time Frame: Month 4 postpartum
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
Time Frame: Month 6 postpartum
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
Time Frame: Month 9 postpartum
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
Time Frame: Month 12 postpartum
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Concentration of CBD in maternal blood
Time Frame: Day 2 postpartum
Day 2 postpartum
Concentration of CBD in maternal blood
Time Frame: Day 21 postpartum
Day 21 postpartum
Concentration of CBD in maternal blood
Time Frame: Day 42 postpartum
Day 42 postpartum
Concentration of CBD in maternal blood
Time Frame: Month 3 postpartum
Month 3 postpartum
Concentration of CBD in maternal blood
Time Frame: Month 4 postpartum
Month 4 postpartum
Concentration of CBD in maternal blood
Time Frame: Month 6 postpartum
Month 6 postpartum
Concentration of CBD in maternal blood
Time Frame: Month 9 postpartum
Month 9 postpartum
Concentration of CBD in maternal blood
Time Frame: Month 12 postpartum
Month 12 postpartum
Concentration of CBD metabolites in maternal blood
Time Frame: Day 2 postpartum
Day 2 postpartum
Concentration of CBD metabolites in maternal blood
Time Frame: Day 21 postpartum
Day 21 postpartum
Concentration of CBD metabolites in maternal blood
Time Frame: Month 3 postpartum
Month 3 postpartum
Concentration of CBD metabolites in maternal blood
Time Frame: Month 4 postpartum
Month 4 postpartum
Concentration of CBD metabolites in maternal blood
Time Frame: Month 6 postpartum
Month 6 postpartum
Concentration of CBD metabolites in maternal blood
Time Frame: Month 9 postpartum
Month 9 postpartum
Concentration of CBD metabolites in maternal blood
Time Frame: Month 12 postpartum
Month 12 postpartum
Concentration of CBD in breast-milk
Time Frame: Day 2 postpartum
Day 2 postpartum
Concentration of CBD in breast-milk
Time Frame: Day 21 postpartum
Day 21 postpartum
Concentration of CBD in breast-milk
Time Frame: Day 42 postpartum
Day 42 postpartum
Concentration of CBD in breast-milk
Time Frame: Month 3 postpartum
Month 3 postpartum
Concentration of CBD in breast-milk
Time Frame: Month 4 postpartum
Month 4 postpartum
Concentration of CBD in breast-milk
Time Frame: Month 6 postpartum
Month 6 postpartum
Concentration of CBD in breast-milk
Time Frame: Month 9 postpartum
Month 9 postpartum
Concentration of CBD in breast-milk
Time Frame: Month 12 postpartum
Month 12 postpartum
THC concentrations in mother's blood
Time Frame: Day 2 postpartum
Day 2 postpartum
THC concentrations in mother's blood
Time Frame: Day 21 postpartum
Day 21 postpartum
THC concentrations in mother's blood
Time Frame: Day 42 postpartum
Day 42 postpartum
THC concentrations in mother's blood
Time Frame: Month 3 postpartum
Month 3 postpartum
THC concentrations in mother's blood
Time Frame: Month 4 postpartum
Month 4 postpartum
THC concentrations in mother's blood
Time Frame: Month 6 postpartum
Month 6 postpartum
THC concentrations in mother's blood
Time Frame: Month 9 postpartum
Month 9 postpartum
THC concentrations in mother's blood
Time Frame: Month 12 postpartum
Month 12 postpartum
THC concentrations in breast milk
Time Frame: Day 2 postpartum
Day 2 postpartum
THC concentrations in breast milk
Time Frame: Day 21 postpartum
Day 21 postpartum
THC concentrations in breast milk
Time Frame: Day 42 postpartum
Day 42 postpartum
THC concentrations in breast milk
Time Frame: Month 3 postpartum
Month 3 postpartum
THC concentrations in breast milk
Time Frame: Month 4 postpartum
Month 4 postpartum
THC concentrations in breast milk
Time Frame: Month 6 postpartum
Month 6 postpartum
THC concentrations in breast milk
Time Frame: Month 9 postpartum
Month 9 postpartum
THC concentrations in breast milk
Time Frame: Month 12 postpartum
Month 12 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Day 2 postpartum
Day 2 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Day 21 postpartum
Day 21 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Day 42 postpartum
Day 42 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Month 3 postpartum
Month 3 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Month 4 postpartum
Month 4 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Month 6 postpartum
Month 6 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Month 9 postpartum
Month 9 postpartum
THC/CBD ratio
Time Frame: Day 2 postpartum
Day 2 postpartum
Percentage of breastfeeding child with CBD in urine
Time Frame: Day 2 postpartum
Day 2 postpartum
Percentage of breastfeeding child with CBD in urine
Time Frame: Day 21 postpartum
Day 21 postpartum
Percentage of breastfeeding child with CBD in urine
Time Frame: Day 42 postpartum
Day 42 postpartum
Percentage of breastfeeding child with CBD in urine
Time Frame: Month 3 postpartum
Month 3 postpartum
Percentage of breastfeeding child with CBD in urine
Time Frame: Month 4 postpartum
Month 4 postpartum
Percentage of breastfeeding child with CBD in urine
Time Frame: Month 6 postpartum
Month 6 postpartum
Percentage of breastfeeding child with CBD in urine
Time Frame: Month 9 postpartum
Month 9 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Day 2 postpartum
Day 2 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Day 21 postpartum
Day 21 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Day 42 postpartum
Day 42 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Month 3 postpartum
Month 3 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Month 4 postpartum
Month 4 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Month 6 postpartum
Month 6 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Month 9 postpartum
Month 9 postpartum
impact of ethnicity
Time Frame: Day 2 postpartum
Day 2 postpartum
Percentage of breastfeeding mother's with CBD in urine
Time Frame: Day 2 postpartum
Day 2 postpartum
Percentage of breastfeeding mother's with CBD in urine
Time Frame: Day 21 postpartum
Day 21 postpartum
Percentage of breastfeeding mother's with CBD in urine
Time Frame: Day 42 postpartum
Day 42 postpartum
Percentage of breastfeeding mother's with CBD in urine
Time Frame: Month 4 postpartum
Month 4 postpartum
Percentage of breastfeeding mother's with CBD in urine
Time Frame: Month 6 postpartum
Month 6 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time Frame: Month 12 postpartum
Month 12 postpartum
Percentage of breastfeeding mother's with CBD in urine
Time Frame: Month 12 postpartum
Month 12 postpartum
Percentage of breastfeeding mother's with CBD in urine
Time Frame: Month 3 postpartum
Month 3 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Time Frame: Month 12 postpartum
Month 12 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Day 2 postpartum
Day 2 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Day 21 postpartum
Day 21 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Day 42 postpartum
Day 42 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Month 3 postpartum
Month 3 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Month 4 postpartum
Month 4 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Month 6 postpartum
Month 6 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Month 9 postpartum
Month 9 postpartum
Percentage of breastfeeding mother's with THC in urine
Time Frame: Month 12 postpartum
Month 12 postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Régional d'Orléans

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr, Chu Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUO-2024-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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