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幼儿头发在急性大麻中毒期间的污染 (INTERACTION)

2026年9月15日 更新者:University Hospital, Toulouse

急性大麻中毒期间幼童头发的汗液污染

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.

研究概览

地位

招聘中

详细说明

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.

研究类型

介入性

注册 (估计的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Toulouse、法国
        • 招聘中
        • Centre Hospitalier Universitaire
        • 接触:
          • Thomas Lanot
        • 首席研究员:
          • Thomas LANOT

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3个月 至 3年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Acide 11-nor-9-carboxy-THC (THC-COOH) concentrations in sweat collected during the first 24 hours following emergency admission.
大体时间:Day 1

concentration measured in sudoral sample (in µg/l)

Day 1

次要结果测量

结果测量
措施说明
大体时间
Tétrahydrocannabinol (THC), 11-hydroxy-tétrahydrocannabinol (OH-THC) and THC-COOH measured in blood and sweat collected during the first 24 hours following emergency admission.
大体时间: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.
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Thomas Lanot、University Hospital of Toulouse

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月31日

初级完成 (估计的)

2028年2月20日

研究完成 (估计的)

2028年4月15日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年4月9日

首次发布 (实际的)

2026年4月13日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • RC31/24/0572

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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