NCT07524088

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

April 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

April 2, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

cannabis intoxicationchildrensudroral contamination

Outcome Measures

Primary Outcomes (1)

  • Acide 11-nor-9-carboxy-THC (THC-COOH) concentrations in sweat collected during the first 24 hours following emergency admission.

    concentration measured in sudoral sample (in µg/l)

    Day 1

Secondary Outcomes (2)

  • Tétrahydrocannabinol (THC), 11-hydroxy-tétrahydrocannabinol (OH-THC) and THC-COOH measured in blood and sweat collected during the first 24 hours following emergency admission.

    Day 1

  • THC, OH-THC and THC-COOH measured in two hair samples.

    day 1 and the day of follow-up visit at month 1 or month 2

Study Arms (1)

intoxicated children

EXPERIMENTAL

children with an intoxication of cannabis admitted to emergency

Other: sudoral and hairing sampling

Interventions

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

intoxicated children

Eligibility Criteria

Age3 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • History of cannabis intoxication identified during the interview and/or consultation of the medical record.
  • Contraindication to sweat sampling (described in section 6).
  • Ongoing breastfeeding (exclusive and mixed).
  • Inability to provide study-related informations to the holders of parental authority.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Thomas Lanot

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 13, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

February 20, 2028

Study Completion (Estimated)

April 15, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04