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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Consumption of Cannabis

Intervention / Treatment
-----------------
* Procedure: 1 blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: regular cannabis consumer patients<br> | Procedure: 1 blood sample<br>* 2 groups of subjects (group 1 : with diagnosis of CHS - group 2 : no diagnosis of CHS) will have 2 blood and 1 urine samples + 1 questionnaire<br>* Other names: 1 urine sample;|

What is the study measuring?
-----------------
Primary Outcome Measures

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