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

Primary Purpose

Chronic Consumption of Cannabis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
1 blood sample
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Consumption of Cannabis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHURecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

regular cannabis consumer patients

Arm Description

Outcomes

Primary Outcome Measures

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
THC (Tetrahydrocannabinol)
blood and urine concentration, unit of measure ng/mL
metabolite of THC : THC-OH (11-hydroxy-Δ⁹-tétrahydrocannabinol)
blood and urine concentration, unit of measure ng/mL
metabolite of THC : THC-COOH (11-nor-9-carboxy-Δ⁹-tétrahydrocannabinol)
blood and urine concentration, unit of measure ng/mL
CBD (Cannabidiol)
blood and urine concentration, unit of measure ng/mL
CBN (Cannabinol)
blood and urine concentration, unit of measure ng/mL
CBG (Cannabigerol)
blood and urine concentration, unit of measure ng/mL

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
September 28, 2021
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04836611
Brief Title
Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
Official Title
Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Consumption of Cannabis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
regular cannabis consumer patients
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
1 blood sample
Other Intervention Name(s)
1 urine sample
Intervention Description
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
Primary Outcome Measure Information:
Title
involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS (see details below for exogenous cannabinoids)
Description
blood and urine concentration, unit of measure ng/mL
Time Frame
on the day of subjects inclusion
Title
THC (Tetrahydrocannabinol)
Description
blood and urine concentration, unit of measure ng/mL
Time Frame
on the day of subjects inclusion
Title
metabolite of THC : THC-OH (11-hydroxy-Δ⁹-tétrahydrocannabinol)
Description
blood and urine concentration, unit of measure ng/mL
Time Frame
on the day of subjects inclusion
Title
metabolite of THC : THC-COOH (11-nor-9-carboxy-Δ⁹-tétrahydrocannabinol)
Description
blood and urine concentration, unit of measure ng/mL
Time Frame
on the day of subjects inclusion
Title
CBD (Cannabidiol)
Description
blood and urine concentration, unit of measure ng/mL
Time Frame
on the day of subjects inclusion
Title
CBN (Cannabinol)
Description
blood and urine concentration, unit of measure ng/mL
Time Frame
on the day of subjects inclusion
Title
CBG (Cannabigerol)
Description
blood and urine concentration, unit of measure ng/mL
Time Frame
on the day of subjects inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
CHU
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GUENEZAN Jérémy, MD
Phone
+33(0)549444444
Email
jeremy.guenezan@chu-poitiers.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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