- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07524088
Forurening af små børns hår under akut cannabisforgiftning (INTERACTION)
Sudoral Kontaminering af Unge Børns Hår Under Akut Cannabisforgiftning
Hair analysis in pediatric cannabis intoxication is limited by possible sudoral self-contamination, especially in young children due to hair porosity. However, adult studies show no THC-COOH in sweat, challenging this hypothesis. THC-COOH presence in sweat has to this day never been studied in young children. Its absence would help assess the reliability of hair testing for prior exposure. Thus, our main objective is to describe whether THC-COOH can be detected in sweat following cannabis intoxication using gold standard techniques.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Nadège Algans
- Telefonnummer: 0561777204
- E-mail: algans.n@chu-toulouse.fr
Studiesteder
-
-
-
Toulouse, Frankrig
- Rekruttering
- Centre Hospitalier Universitaire
-
Kontakt:
- Thomas Lanot
-
Ledende efterforsker:
- Thomas LANOT
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Acide 11-nor-9-carboxy-THC (THC-COOH) concentrations in sweat collected during the first 24 hours following emergency admission.
Tidsramme: Day 1
|
concentration measured in sudoral sample (in µg/l) |
Day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tétrahydrocannabinol (THC), 11-hydroxy-tétrahydrocannabinol (OH-THC) and THC-COOH measured in blood and sweat collected during the first 24 hours following emergency admission.
Tidsramme: 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.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas Lanot, University Hospital of Toulouse
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- RC31/24/0572
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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