Breast FeedingCBD-ALLTNCT06589258
Cannabidiol Into Breastmilk
A study testing Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding in people with Breast Feeding, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18
- Breastfeeding CBD user
- Having given written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr contact
France1 site, 1 recruiting
- Recruiting
CHU Orléans
Orléans
Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr, marie-philippe.lebouchard-maakaroun@chu-orleans.fr
Marie-Philippe LEBOUCHARD-MAAKAROUN
About this study
Official title: 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.
- Conditions
- Breast Feeding
- Being tested
- Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding
- Keywords
- cannabidiol, Breast milk, Breast-feeding, Breast-feed children, PK POP
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing maternal and lactational plasma CBD uptake at different stages of breastfeedingBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| breastfeeding mothers with CBD's consumption | Other | 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). Receives: Biological: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Day 2 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Day 21 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Day 42 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Month 3 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Month 4 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Month 6 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Month 9 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Measured: Month 12 postpartum
Secondary outcomes (79)
Concentration of CBD in maternal blood
Measured: Day 2 postpartum
Concentration of CBD in maternal blood
Measured: Day 21 postpartum
Concentration of CBD in maternal blood
Measured: Day 42 postpartum
Concentration of CBD in maternal blood
Measured: Month 3 postpartum
Concentration of CBD in maternal blood
Measured: Month 4 postpartum
Concentration of CBD in maternal blood
Measured: Month 6 postpartum
Concentration of CBD in maternal blood
Measured: Month 9 postpartum
Concentration of CBD in maternal blood
Measured: Month 12 postpartum
Concentration of CBD metabolites in maternal blood
Measured: Day 2 postpartum
Concentration of CBD metabolites in maternal blood
Measured: Day 21 postpartum
Concentration of CBD metabolites in maternal blood
Measured: Month 3 postpartum
Concentration of CBD metabolites in maternal blood
Measured: Month 4 postpartum
Concentration of CBD metabolites in maternal blood
Measured: Month 6 postpartum
Concentration of CBD metabolites in maternal blood
Measured: Month 9 postpartum
Concentration of CBD metabolites in maternal blood
Measured: Month 12 postpartum
Concentration of CBD in breast-milk
Measured: Day 2 postpartum
Concentration of CBD in breast-milk
Measured: Day 21 postpartum
Concentration of CBD in breast-milk
Measured: Day 42 postpartum
Concentration of CBD in breast-milk
Measured: Month 3 postpartum
Concentration of CBD in breast-milk
Measured: Month 4 postpartum
Concentration of CBD in breast-milk
Measured: Month 6 postpartum
Concentration of CBD in breast-milk
Measured: Month 9 postpartum
Concentration of CBD in breast-milk
Measured: Month 12 postpartum
THC concentrations in mother's blood
Measured: Day 2 postpartum
THC concentrations in mother's blood
Measured: Day 21 postpartum
THC concentrations in mother's blood
Measured: Day 42 postpartum
THC concentrations in mother's blood
Measured: Month 3 postpartum
THC concentrations in mother's blood
Measured: Month 4 postpartum
THC concentrations in mother's blood
Measured: Month 6 postpartum
THC concentrations in mother's blood
Measured: Month 9 postpartum
THC concentrations in mother's blood
Measured: Month 12 postpartum
THC concentrations in breast milk
Measured: Day 2 postpartum
THC concentrations in breast milk
Measured: Day 21 postpartum
THC concentrations in breast milk
Measured: Day 42 postpartum
THC concentrations in breast milk
Measured: Month 3 postpartum
THC concentrations in breast milk
Measured: Month 4 postpartum
THC concentrations in breast milk
Measured: Month 6 postpartum
THC concentrations in breast milk
Measured: Month 9 postpartum
THC concentrations in breast milk
Measured: Month 12 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Day 2 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Day 21 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Day 42 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Month 3 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Month 4 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Month 6 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Month 9 postpartum
THC/CBD ratio
Measured: Day 2 postpartum
Percentage of breastfeeding child with CBD in urine
Measured: Day 2 postpartum
Percentage of breastfeeding child with CBD in urine
Measured: Day 21 postpartum
Percentage of breastfeeding child with CBD in urine
Measured: Day 42 postpartum
Percentage of breastfeeding child with CBD in urine
Measured: Month 3 postpartum
Percentage of breastfeeding child with CBD in urine
Measured: Month 4 postpartum
Percentage of breastfeeding child with CBD in urine
Measured: Month 6 postpartum
Percentage of breastfeeding child with CBD in urine
Measured: Month 9 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Day 2 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Day 21 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Day 42 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Month 3 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Month 4 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Month 6 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Month 9 postpartum
impact of ethnicity
Measured: Day 2 postpartum
Percentage of breastfeeding mother's with CBD in urine
Measured: Day 2 postpartum
Percentage of breastfeeding mother's with CBD in urine
Measured: Day 21 postpartum
Percentage of breastfeeding mother's with CBD in urine
Measured: Day 42 postpartum
Percentage of breastfeeding mother's with CBD in urine
Measured: Month 4 postpartum
Percentage of breastfeeding mother's with CBD in urine
Measured: Month 6 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Measured: Month 12 postpartum
Percentage of breastfeeding mother's with CBD in urine
Measured: Month 12 postpartum
Percentage of breastfeeding mother's with CBD in urine
Measured: Month 3 postpartum
Percentage of breastfeeding child with CBD metabolites in urine
Measured: Month 12 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Day 2 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Day 21 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Day 42 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Month 3 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Month 4 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Month 6 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Month 9 postpartum
Percentage of breastfeeding mother's with THC in urine
Measured: Month 12 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr, Principal investigator, CHU Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589258
- Sponsor's protocol ID
- CHUO-2024-02
- Acronym
- CBD-ALLT
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34008796Costentin 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.
PubMed 32296244Potenza 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.
PubMed 37133830Johnson 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.
PubMed 34115948Batalla 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.
PubMed 31330972Hurd 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.
PubMed 26269227Paulus 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.
PubMed 35580370
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Passage of (CBD) Into Breast Milk and Its Biological Impact on Breast-fed Children
- ClinicalTrials.gov ID
- NCT06589258
- Acronym / sponsor ID
- CBD-ALLT / CHUO-2024-02
- Conditions
- Breast Feeding
- Keywords
- cannabidiol, Breast milk, Breast-feeding, Breast-feed children, PK POP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| breastfeeding mothers with CBD's consumption | Other | Biological: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeedingDetermination 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over 18
- Breastfeeding CBD user
- Having given written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessing maternal and lactational plasma CBD uptake at different stages of breastfeedingDetermination 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). | Biological | breastfeeding mothers with CBD's consumption |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
79 secondary outcomes
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
Concentration of CBD metabolites in maternal blood
Time frame: Month 6 postpartum
Concentration of CBD metabolites in maternal blood
Time frame: Month 9 postpartum
Concentration of CBD metabolites in maternal blood
Time frame: Month 12 postpartum
Concentration of CBD in breast-milk
Time frame: Day 2 postpartum
Concentration of CBD in breast-milk
Time frame: Day 21 postpartum
Concentration of CBD in breast-milk
Time frame: Day 42 postpartum
Concentration of CBD in breast-milk
Time frame: Month 3 postpartum
Concentration of CBD in breast-milk
Time frame: Month 4 postpartum
Concentration of CBD in breast-milk
Time frame: Month 6 postpartum
Concentration of CBD in breast-milk
Time frame: Month 9 postpartum
Concentration of CBD in breast-milk
Time frame: Month 12 postpartum
THC concentrations in mother's blood
Time frame: Day 2 postpartum
THC concentrations in mother's blood
Time frame: Day 21 postpartum
THC concentrations in mother's blood
Time frame: Day 42 postpartum
THC concentrations in mother's blood
Time frame: Month 3 postpartum
THC concentrations in mother's blood
Time frame: Month 4 postpartum
THC concentrations in mother's blood
Time frame: Month 6 postpartum
THC concentrations in mother's blood
Time frame: Month 9 postpartum
THC concentrations in mother's blood
Time frame: Month 12 postpartum
THC concentrations in breast milk
Time frame: Day 2 postpartum
THC concentrations in breast milk
Time frame: Day 21 postpartum
THC concentrations in breast milk
Time frame: Day 42 postpartum
THC concentrations in breast milk
Time frame: Month 3 postpartum
THC concentrations in breast milk
Time frame: Month 4 postpartum
THC concentrations in breast milk
Time frame: Month 6 postpartum
THC concentrations in breast milk
Time frame: Month 9 postpartum
THC concentrations in breast milk
Time frame: Month 12 postpartum
Percentage of breastfeeding mother's with CBD metabolites in urine
Time frame: Day 2 postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 34008796Kessler 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.
- Background: PubMed 32296244Costentin 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.
- Background: PubMed 37133830Potenza 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.
- Background: PubMed 34115948Johnson 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.
- Background: PubMed 31330972Batalla 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.
- Background: PubMed 26269227Hurd 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.
- Background: PubMed 35580370Paulus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr contact
Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr principal investigator
CHU Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding in people with Breast Feeding, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Philippe LEBOUCHARD-MAAKAROUN, Dr (+33238744181, marie-philippe.lebouchard-maakaroun@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theoretical dose of CBD received by the breastfed child over 24 hours (time frame: Day 2 postpartum). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589258, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.