Cannabinoid Hyperemesis Syndrome. Prospective Multicenter Study of Patients Admitted to Adult Emergency Departments in Maine-et-Loire.

NCT ID: NCT06660901

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-10-31

Brief Summary

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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

Detailed Description

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Conditions

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D000096704 Cannabinoid Hyperemesis Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cannabinoid hyperemesis syndrome

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Refusal to participate in the study
* Patient unable to answer questionnaire (allophone, under guardianship, under protection, incapable of age, under legal proceedings)
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien DENIS, Doctor

Role: PRINCIPAL_INVESTIGATOR

Saumur Hospital Center

Locations

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Angers Centre Hospitalier Universitaire (CHU)

Angers, , France

Site Status RECRUITING

Centre Hospitalier de Cholet

Cholet, , France

Site Status RECRUITING

Centre Hospitalier de Saumur

Saumur, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien DENIS, Doctor

Role: CONTACT

+33 2 41 53 30 30

Facility Contacts

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LUCILE RONZI, MD

Role: primary

06 65 80 66 10

Recherche Clinique MU, MS

Role: backup

Caroline SOULIE-CHAVIGNON, MD

Role: primary

02 41 49 69 85

Marion Jacob, MS

Role: backup

Julien DENIS, MD

Role: primary

02 41 53 30 30

Other Identifiers

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49RC24_0175

Identifier Type: -

Identifier Source: org_study_id

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