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

September 28, 2021 updated by: Poitiers University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: regular cannabis consumer patients
Procedure: 1 blood sample
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
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)
Time Frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
on the day of subjects inclusion
THC (Tetrahydrocannabinol)
Time Frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
on the day of subjects inclusion
metabolite of THC : THC-OH (11-hydroxy-Δ⁹-tétrahydrocannabinol)
Time Frame: on the day of subjects inclusion
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)
Time Frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
on the day of subjects inclusion
CBD (Cannabidiol)
Time Frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
on the day of subjects inclusion
CBN (Cannabinol)
Time Frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
on the day of subjects inclusion
CBG (Cannabigerol)
Time Frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
on the day of subjects inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2021

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CANEMESE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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