D000096704CANN-AIENCT06660901
Cannabinoid Hyperemesis Syndrome. Prospective Multicenter Study of Patients Admitted to Adult Emergency Departments in Maine-et-Loire.
An observational study of D000096704 and Cannabinoid Hyperemesis Syndrome, run by University Hospital, Angers at 3 sites in France.
Trial summary
Cannabinoid hyperemesis syndrome (CHS) is characterized by incoercible abdominal pain and vomiting in patients with chronic cannabis use. Patients are relieved by hot showers, an easily performed diagnostic test. The prevalence of this syndrome in France is not well known. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- D000096704, Cannabinoid Hyperemesis Syndrome
- How many people
- 3,000 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Jul 2025to 31 Oct 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Adult, Older adult
Study population: At present, there are no data on the incidence of CHS in the French literature. In order to assess the number of subjects required, we made a projection based on the only French study to date. In this study, carried out in two departments in Marseille, the percentage of patients with CHS among those consulting the emergency department for acute abdominal pain was 1.6%. Thus, assuming that the proportion of the event will be identical to that of the study carried out in Marseille, i.e. 1.6%, it would be necessary to recruit 3,000 people with abdominal pain and/or vomiting to have around 50 patients with CHS.
Who may be able to join
- Patient aged 18 to 65 years,
- Consulted the Maine et Loire adult emergency department for abdominal pain and/or vomiting for the 1st time during the study period.
Who cannot join
- Refusal to participate in the study
- Patient unable to answer questionnaire (allophone, under guardianship, under protection, incapable of age, under legal proceedings)
- Pregnant women
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Angers Centre Hospitalier Universitaire (CHU)
Angers, 49100
LUCILE RONZI, MD, 06 65 80 66 10, lucile.bruere@chu-angers.fr
Recherche Clinique MU, MS, Recherche-Clinique-MU@chu-angers.fr
- Recruiting
Centre Hospitalier de Cholet
Cholet, 49300
Caroline SOULIE-CHAVIGNON, MD, 02 41 49 69 85, caroline.soulie-chavignon@ch-cholet.fr
Marion Jacob, MS, marion.jacob@ch-cholet.fr
- Recruiting
Centre Hospitalier de Saumur
Saumur, 49400
Julien DENIS, MD, 02 41 53 30 30, julien.denis@ch-saumur.fr
Julien DENIS, MD
About this study
Cannabinoid hyperemesis syndrome (CHS) is characterized by incoercible abdominal pain and vomiting in patients with chronic cannabis use. Patients are relieved by hot showers, an easily performed diagnostic test.
The prevalence of this syndrome in France is not well known. A single French study from 2021, carried out in two Marseille emergency departments, estimated a 1.6% prevalence of CHS (48 cases / 2848 patients) in patients consulting for acute abdominal pain with no etiology found over a 10-month period.
Read more
Cannabis is the most widely used illicit substance in France. France is also the second biggest cannabis consumer in Europe, with around 11% of the French population currently using the drug (use within the year).
Despite growing attention to CHS, the diagnosis and management of this syndrome remains difficult, with repeated visits to emergency departments often required before a diagnosis is made. What's more, once the diagnosis has been made, the severity of symptoms can lengthen the emergency room length of stay.
Main objective:
To estimate the incidence of cannabinoid hyperemesis syndrome among patients admitted on a first visit for abdominal pain and/or vomiting to the Maine et Loire emergency department.
Primary endpoint:
The incidence of cannabinoid hyperemesis syndrome among patients presenting with abdominal pain and/or vomiting, consulting adult emergency departments in Maine et Loire. Cannabinoid hyperemesis syndrome will be considered in all patients admitted for abdominal pain and/or vomiting, who are regular cannabis users (weekly use for more than 6 months declared by questionnaire) and in whom no other etiology is accepted after any additional examinations.
Research plan and procedure:
It is an observational, prospective, multi-center cohort study. Participation in the study is offered to any emergency room patient who meets all inclusion criteria and none of the non-inclusion criteria. Patients are included after reading the information note. Consent is obtained on a no-objection basis.
A questionnaire is given to participants via a QR code with an identification number generated by the investigating physician. This QR code opens an online questionnaire that the patient can fill in while in the emergency department. In the absence of access to the QR code (no cell phone), the questionnaire will be given to the participant in paper format by the investigating physician. It will be collected at the end of the inclusion visit.
Participants who have revealed cannabis use (at least 1 time per week for at least 6 months) via the questionnaire are followed up at 3 months (+/- 15 days) by telephone to assess the evolution of symptoms, any recurrences, medical treatment and whether or not cannabis has been withdrawn.
Inclusion criteria:
- Patients aged 18 to 65 years,
- Consulted an adult emergency department in Maine et Loire for abdominal pain and/or vomiting for the 1st time during the study period.
Non-inclusion criteria:
- Refusal to participate in the study
- Patient unable to answer the questionnaire (allophone, under guardianship, under protection, incapable of major age, in the process of legal proceedings)
- Pregnant women
Number of research participants:
At present, there are no data on the incidence of CHS in the French literature. In order to assess the number of subjects required, we made a projection based on the only French study to date. In this study, carried out in two departments in Marseille, the percentage of patients with CHS among those consulting the emergency department for acute abdominal pain was 1.6%. Thus, assuming that the proportion of the event will be identical to that of the study carried out in Marseille, i.e. 1.6%, it would be necessary to recruit 3,000 people with abdominal pain and/or vomiting to have around 50 patients with CHS.
Research duration:
Inclusion period: 12 months Duration of participation: 3 months +/- 15 days (for patients with CHS) Study duration: 15 months
- Conditions
- D000096704, Cannabinoid Hyperemesis Syndrome
- Keywords
- marijuana, cannabis, Recurrent vomiting, nausea, abdominal pain, compulsive hot bathing behavior
- Medical subject headings
- Cannabinoid Hyperemesis Syndrome, Marijuana Abuse, Vomiting, Nausea, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cannabinoid hyperemesis syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with confirmed cannabinoid hyperemesis syndrome (CHS) among patients presenting with abdominal pain and/or vomiting, consulting adult emergency departments in Maine et Loire
The incidence of cannabinoid hyperemesis syndrome among patients presenting with abdominal pain and/or vomiting, consulting adult emergency departments in Maine et Loire. Cannabinoid hyperemesis syndrome will be considered in all patients admitted for abdominal pain and/or vomiting, who are regular cannabis users (weekly use for more than 6 months declared by questionnaire) and in whom no other etiology is accepted after further investigations.
Measured: Inclusion period will last 12 month and the whole study 15 month. Participation of each CHS positive patient is expected to last 3 month +/- 15 days.
Secondary outcomes (9)
Gender and age distribution of patients with cannabinoid hyperhaemesis syndrome (CHS)
Socio-demographic data for the CHS population: gender, age
Measured: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Description and Distribution of CHS patients across clinical characteristics listing
Clinical characteristics of patients with CHS:
frequency, type and location of abdominal pain, schedule of vomiting, improved by hot shower or not.
Measured: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Describe cannabis use in patients with CHS: duration and frequency of use
Measured: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Describe hospital management and therapies used for patients with CHS: additional tests performed, effectiveness of therapies (analgesics, antiemetics), patient pathway (discharge, short-term hospitalization unit, hospitalization).
Measured: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Number of cannabis withdrawal attempts at 3 months in patients with CHS
Measured: 3 months +/- 15 days
Number of patients with recurrence of symptoms (abdominal pain and/or vomiting) at 3 months
Measured: 3 monts +/- 15 days
Number of patients reporting total cessation of cannabis use at 3 months post-inclusion
Measured: 3 months +/- 15 days
Number of patients who need to consult again (emergency, general practitioner, other) at 3 months
Measured: 3 months +/- 15 days
Number of patients reporting a consultation with an addictology referral at 3 months
Measured: 3 months +/- 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start25 Jul 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D000096704Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Julien DENIS, Doctor, Principal investigator, Saumur Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660901
- Sponsor's protocol ID
- 49RC24_0175
- Acronym
- CANN-AIE
- Status last verified
- Aug 2025
- First submitted
- 24 Oct 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoid Hyperemesis Syndrome. Prospective Multicenter Study of Patients Admitted to Adult Emergency Departments in Maine-et-Loire.
- ClinicalTrials.gov ID
- NCT06660901
- Acronym / sponsor ID
- CANN-AIE / 49RC24_0175
- Conditions
- D000096704, Cannabinoid Hyperemesis Syndrome
- Keywords
- marijuana, cannabis, Recurrent vomiting, nausea, abdominal pain, compulsive hot bathing behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Oct 2024 (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.
Cannabinoid hyperemesis syndrome (CHS) is characterized by incoercible abdominal pain and vomiting in patients with chronic cannabis use. Patients are relieved by hot showers, an easily performed diagnostic test.
The prevalence of this syndrome in France is not well known. A single French study from 2021, carried out in two Marseille emergency departments, estimated a 1.6% prevalence of CHS (48 cases / 2848 patients) in patients consulting for acute abdominal pain with no etiology found over a 10-month period.
Cannabis is the most widely used illicit substance in France. France is also the second biggest cannabis consumer in Europe, with around 11% of the French population currently using the drug (use within the year).
Despite growing attention to CHS, the diagnosis and management of this syndrome remains difficult, with repeated visits to emergency departments often required before a diagnosis is made. What's more, once the diagnosis has been made, the severity of symptoms can lengthen the emergency room length of stay.
Main objective:
To estimate the incidence of cannabinoid hyperemesis syndrome among patients admitted on a first visit for abdominal pain and/or vomiting to the Maine et Loire emergency department.
Primary endpoint:
The incidence of cannabinoid hyperemesis syndrome among patients presenting with abdominal pain and/or vomiting, consulting adult emergency departments in Maine et Loire. Cannabinoid hyperemesis syndrome will be considered in all patients admitted for abdominal pain and/or vomiting, who are regular cannabis users (weekly use for more than 6 months declared by questionnaire) and in whom no other etiology is accepted after any additional examinations.
Research plan and procedure:
It is an observational, prospective, multi-center cohort study. Participation in the study is offered to any emergency room patient who meets all inclusion criteria and none of the non-inclusion criteria. Patients are included after reading the information note. Consent is obtained on a no-objection basis.
A questionnaire is given to participants via a QR code with an identification number generated by the investigating physician. This QR code opens an online questionnaire that the patient can fill in while in the emergency department. In the absence of access to the QR code (no cell phone), the questionnaire will be given to the participant in paper format by the investigating physician. It will be collected at the end of the inclusion visit.
Participants who have revealed cannabis use (at least 1 time per week for at least 6 months) via the questionnaire are followed up at 3 months (+/- 15 days) by telephone to assess the evolution of symptoms, any recurrences, medical treatment and whether or not cannabis has been withdrawn.
Inclusion criteria:
- Patients aged 18 to 65 years,
- Consulted an adult emergency department in Maine et Loire for abdominal pain and/or vomiting for the 1st time during the study period.
Non-inclusion criteria:
- Refusal to participate in the study
- Patient unable to answer the questionnaire (allophone, under guardianship, under protection, incapable of major age, in the process of legal proceedings)
- Pregnant women
Number of research participants:
At present, there are no data on the incidence of CHS in the French literature. In order to assess the number of subjects required, we made a projection based on the only French study to date. In this study, carried out in two departments in Marseille, the percentage of patients with CHS among those consulting the emergency department for acute abdominal pain was 1.6%. Thus, assuming that the proportion of the event will be identical to that of the study carried out in Marseille, i.e. 1.6%, it would be necessary to recruit 3,000 people with abdominal pain and/or vomiting to have around 50 patients with CHS.
Research duration:
Inclusion period: 12 months Duration of participation: 3 months +/- 15 days (for patients with CHS) Study duration: 15 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cannabinoid hyperemesis syndrome | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- At present, there are no data on the incidence of CHS in the French literature. In order to assess the number of subjects required, we made a projection based on the only French study to date. In this study, carried out in two departments in Marseille, the percentage of patients with CHS among those consulting the emergency department for acute abdominal pain was 1.6%. Thus, assuming that the proportion of the event will be identical to that of the study carried out in Marseille, i.e. 1.6%, it would be necessary to recruit 3,000 people with abdominal pain and/or vomiting to have around 50 patients with CHS.
Key inclusion criteria (2 listed)
- Patient aged 18 to 65 years,
- Consulted the Maine et Loire adult emergency department for abdominal pain and/or vomiting for the 1st time during the study period.
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Patient unable to answer questionnaire (allophone, under guardianship, under protection, incapable of age, under legal proceedings)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with confirmed cannabinoid hyperemesis syndrome (CHS) among patients presenting with abdominal pain and/or vomiting, consulting adult emergency departments in Maine et Loire
Time frame: Inclusion period will last 12 month and the whole study 15 month. Participation of each CHS positive patient is expected to last 3 month +/- 15 days.
The incidence of cannabinoid hyperemesis syndrome among patients presenting with abdominal pain and/or vomiting, consulting adult emergency departments in Maine et Loire. Cannabinoid hyperemesis syndrome will be considered in all patients admitted for abdominal pain and/or vomiting, who are regular cannabis users (weekly use for more than 6 months declared by questionnaire) and in whom no other etiology is accepted after further investigations.
9 secondary outcomes
Gender and age distribution of patients with cannabinoid hyperhaemesis syndrome (CHS)
Time frame: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Description and Distribution of CHS patients across clinical characteristics listing
Time frame: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Describe cannabis use in patients with CHS: duration and frequency of use
Time frame: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Describe hospital management and therapies used for patients with CHS: additional tests performed, effectiveness of therapies (analgesics, antiemetics), patient pathway (discharge, short-term hospitalization unit, hospitalization).
Time frame: Inclusion period will last 12 months and the whole study 15 months. Participation of each CHS positive patient is expected to last 3 months +/- 15 days.
Number of cannabis withdrawal attempts at 3 months in patients with CHS
Time frame: 3 months +/- 15 days
Number of patients with recurrence of symptoms (abdominal pain and/or vomiting) at 3 months
Time frame: 3 monts +/- 15 days
Number of patients reporting total cessation of cannabis use at 3 months post-inclusion
Time frame: 3 months +/- 15 days
Number of patients who need to consult again (emergency, general practitioner, other) at 3 months
Time frame: 3 months +/- 15 days
Number of patients reporting a consultation with an addictology referral at 3 months
Time frame: 3 months +/- 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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.
Julien DENIS, Doctor principal investigator
Saumur Hospital Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of D000096704 and Cannabinoid Hyperemesis Syndrome, run by University Hospital, Angers at 3 sites 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien DENIS, Doctor (+33 2 41 53 30 30, julien.denis@ch-saumur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with confirmed cannabinoid hyperemesis syndrome (CHS) among patients presenting with abdominal pain and/or vomiting, consulting adult emergency departments in Maine et Loire (time frame: Inclusion period will last 12 month and the whole study 15 month. Participation of each CHS positive patient is expected to last 3 month +/- 15 days.). 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 28 Aug 2025.