Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
March 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedOctober 6, 2021
September 1, 2021
2 years
March 29, 2021
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (7)
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
Study Arms (1)
regular cannabis consumer patients
OTHERInterventions
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
Eligibility Criteria
You may qualify if:
- Subjects without protection by a legal regime (guardianship, trusteeship)
- Subjects affiliated to an appropriate social security system
- Subjects must sign an informed consent form
- \- Subjects must have the CHS diagnosis confirmed
- \- Subjects must be chronic cannabis consumers and never had CHS
You may not qualify if:
- Subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU
Poitiers, 86000, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 8, 2021
Study Start
July 1, 2021
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
October 6, 2021
Record last verified: 2021-09