Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)

Not Applicable

• Conditions: Chronic Consumption of Cannabis
• Interventions: Procedure: 1 blood sample

• Registration Number: NCT04836611
• Lead Sponsor: Poitiers University Hospital

Brief Summary

The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018).

The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Study Start: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects without protection by a legal regime (guardianship, trusteeship)
• Subjects affiliated to an appropriate social security system
• Subjects must sign an informed consent form

Inclusion Criteria for Group 1:

• Subjects must have the CHS diagnosis confirmed

Inclusion Criteria for Group 2:

• Subjects must be chronic cannabis consumers and never had CHS

Exclusion Criteria

• Subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
regular cannabis consumer patients	1 blood sample	-

Primary Outcome Measures

Name	Time	Method
involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS (see details below for exogenous cannabinoids)	on the day of subjects inclusion	blood and urine concentration, unit of measure ng/mL
THC (Tetrahydrocannabinol)	on the day of subjects inclusion	blood and urine concentration, unit of measure ng/mL
metabolite of THC : THC-COOH (11-nor-9-carboxy-Δ⁹-tétrahydrocannabinol)	on the day of subjects inclusion	blood and urine concentration, unit of measure ng/mL
CBN (Cannabinol)	on the day of subjects inclusion	blood and urine concentration, unit of measure ng/mL
metabolite of THC : THC-OH (11-hydroxy-Δ⁹-tétrahydrocannabinol)	on the day of subjects inclusion	blood and urine concentration, unit of measure ng/mL
CBD (Cannabidiol)	on the day of subjects inclusion	blood and urine concentration, unit of measure ng/mL
CBG (Cannabigerol)	on the day of subjects inclusion	blood and urine concentration, unit of measure ng/mL

Trial Locations

Locations (1)

CHU; 🇫🇷 Poitiers, France