Chronic Consumption of CannabisNCT04836611
Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
A study testing 1 blood sample in people with Chronic Consumption of Cannabis, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Consumption of Cannabis
- What is being tested?
- 1 blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Poitiers, 86000
GUENEZAN Jérémy, MD, +33(0)549444444, jeremy.guenezan@chu-poitiers.fr
About this study
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.
- Conditions
- Chronic Consumption of Cannabis
- Being tested
- 1 blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 blood sampleProcedure or surgery
Also called 1 urine 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
| Study group | Role | What they receive |
|---|---|---|
| regular cannabis consumer patients | Other | Not described Receives: Procedure: 1 blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: on the day of subjects inclusion
THC (Tetrahydrocannabinol)
blood and urine concentration, unit of measure ng/mL
Measured: on the day of subjects inclusion
metabolite of THC : THC-OH (11-hydroxy-Δ⁹-tétrahydrocannabinol)
blood and urine concentration, unit of measure ng/mL
Measured: 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
Measured: on the day of subjects inclusion
CBD (Cannabidiol)
blood and urine concentration, unit of measure ng/mL
Measured: on the day of subjects inclusion
CBN (Cannabinol)
blood and urine concentration, unit of measure ng/mL
Measured: on the day of subjects inclusion
CBG (Cannabigerol)
blood and urine concentration, unit of measure ng/mL
Measured: on the day of subjects inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Consumption of CannabisStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836611
- Sponsor's protocol ID
- CANEMESE
- Status last verified
- Sep 2021
- First submitted
- 29 Mar 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
- ClinicalTrials.gov ID
- NCT04836611
- Acronym / sponsor ID
- CANEMESE
- Conditions
- Chronic Consumption of Cannabis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| regular cannabis consumer patients | Other | Procedure: 1 blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 blood sampleAlso: 1 urine sample2 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 | Procedure or surgery | regular cannabis consumer patients |
Primary outcome
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
THC (Tetrahydrocannabinol)
Time frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
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
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
CBD (Cannabidiol)
Time frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
CBN (Cannabinol)
Time frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
CBG (Cannabigerol)
Time frame: on the day of subjects inclusion
blood and urine concentration, unit of measure ng/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 blood sample in people with Chronic Consumption of Cannabis, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.