- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524088
Contamination of Young Children Hair During Acute Cannabis Intoxication (INTERACTION)
Sudoral Contamination of Young Children Hair During Acute Cannabis Intoxication
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In cases of pediatric cannabis intoxication, hair analysis is frequently used to assess prior exposure. However, in young children, especially under 3 years old, hair porosity raises concerns about external contamination, notably through sweat. It has been hypothesized that cannabinoids could migrate into the hair via sweat shortly after ingestion, leading to self-contamination and potentially compromising the interpretation of results. This is particularly relevant when trying to distinguish acute ingestion from chronic exposure. In adults, several studies have shown no detectable sudoral concentrations of THC-COOH, the main metabolite used in hair testing, suggesting that such contamination is unlikely. However, due to developmental differences in pharmacokinetics, these findings cannot yet be extrapolated to children. Confirming the absence of THC-COOH in pediatric sweat would strengthen the validity of hair testing as a retrospective exposure tool.
This study would be performed on young children admitted to the emergency department for accidental cannabis intoxication. Sweat would be collected at inclusion using a similar procedure to a sweat test by stimulating sudation using pilocarpine and mild electrical stimulation. Cannabinoids would be analyzed by liquid chromatography coupled with mass spectrometry (LC-MS), which is the gold standard technique.
Follow-up would be simple, consisting in a single consultation 1 to 2 months following inclusion. This consultation is part of the usual medical care for young children following cannabis intoxication.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nadège ALGANS
- Phone Number: 0561777204
- Email: algans.n@chu-toulouse.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child admitted to the Specialized Emergency Pole (POSU) and pediatric medico-surgical emergencies for acute cannabis intoxication.
- Child older than 3 months and younger than 3 years.
- Holders of parental authority, affiliated with or beneficiaries of a social security system.
Exclusion Criteria:
- History of cannabis intoxication identified during the interview and/or consultation of the medical record.
- Contraindication to sweat sampling (described in section 6).
- Absence of hair and/or hair length < 1 cm at the time of inclusion.
- Ongoing breastfeeding (exclusive and mixed).
- Inability to provide study-related informations to the holders of parental authority.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intoxicated children
children with an intoxication of cannabis admitted to emergency
|
Sweat sampling using the "sweat test" method, performed after skin stimulation with pilocarpine and a low electrical stimulation.
Hair sampling during the follow-up consultation.
Sweat, and capillary assays of THC and its main metabolites
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acide 11-nor-9-carboxy-THC (THC-COOH) concentrations in sweat collected during the first 24 hours following emergency admission.
Time Frame: Day 1
|
concentration measured in sudoral sample (in µg/l)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tétrahydrocannabinol (THC), 11-hydroxy-tétrahydrocannabinol (OH-THC) and THC-COOH measured in blood and sweat collected during the first 24 hours following emergency admission.
Time Frame: Day 1
|
Determination whether blood and sweat THC, OH-THC and THC-COOH concentrations, if present, are correlated following intoxication (in µg/l)
|
Day 1
|
|
THC, OH-THC and THC-COOH measured in two hair samples.
Time Frame: day 1 and the day of follow-up visit at month 1 or month 2
|
Describing the evolution of THC, OH-THC and THC-COOH hair concentrations in young children (in µg/l)
|
day 1 and the day of follow-up visit at month 1 or month 2
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Lanot, University Hospital of Toulouse
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RC31/24/0572
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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