Chronic Consumption of Cannabis Clinical Trial
Official title:
Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
| NCT number | NCT04836611 |
| Other study ID # | CANEMESE |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 1, 2021 |
| Est. completion date | June 30, 2023 |
| Verified date | September 2021 |
| Source | Poitiers University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | June 30, 2023 |
| Est. primary completion date | June 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | THC (Tetrahydrocannabinol) | blood and urine concentration, unit of measure ng/mL | on the day of subjects inclusion | |
| Primary | metabolite of THC : THC-OH (11-hydroxy-??-tétrahydrocannabinol) | blood and urine concentration, unit of measure ng/mL | on the day of subjects inclusion | |
| Primary | metabolite of THC : THC-COOH (11-nor-9-carboxy-??-tétrahydrocannabinol) | blood and urine concentration, unit of measure ng/mL | on the day of subjects inclusion | |
| Primary | CBD (Cannabidiol) | blood and urine concentration, unit of measure ng/mL | on the day of subjects inclusion | |
| Primary | CBN (Cannabinol) | blood and urine concentration, unit of measure ng/mL | on the day of subjects inclusion | |
| Primary | CBG (Cannabigerol) | blood and urine concentration, unit of measure ng/mL | on the day of subjects inclusion |