Contaminación del Cabello de Niños Pequeños Durante una Intoxicación Aguda por Cannabis (INTERACTION)
Contaminación Sudoral del Cabello de Niños Pequeños Durante una Intoxicación Aguda por Cannabis
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nadège Algans
- Número de teléfono: 0561777204
- Correo electrónico: algans.n@chu-toulouse.fr
Ubicaciones de estudio
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Toulouse, Francia
- Reclutamiento
- Centre Hospitalier Universitaire
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Contacto:
- Thomas Lanot
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Investigador principal:
- Thomas LANOT
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acide 11-nor-9-carboxy-THC (THC-COOH) concentrations in sweat collected during the first 24 hours following emergency admission.
Periodo de tiempo: Day 1
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concentration measured in sudoral sample (in µg/l) |
Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tétrahydrocannabinol (THC), 11-hydroxy-tétrahydrocannabinol (OH-THC) and THC-COOH measured in blood and sweat collected during the first 24 hours following emergency admission.
Periodo de tiempo: 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
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THC, OH-THC and THC-COOH measured in two hair samples.
Periodo de tiempo: day 1 and the day of follow-up visit at month 1 or month 2
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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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas Lanot, University Hospital of Toulouse
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RC31/24/0572
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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