Cannabinoid Hyperemesis SyndromePhase 3CH2ONCT07246187
Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department
A Phase 3 study testing Olanzapine 10 milligram and Haloperidol in people with Cannabinoid Hyperemesis Syndrome, run by Mercy Bon Secours Saint Vincent Medical Center at 1 site in United States.
Trial summary
The aim of the study is to identify which medication (haloperidol or olanzapine) is most effective in treating nausea and abdominal pain associated with cannabinoid hyperemesis using a 10-point visual analog scale with intervals of 0.5. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cannabinoid Hyperemesis Syndrome
- What is being tested?
- Olanzapine 10 milligram and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to 1 Oct 2026
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects must meet ONE of the below criteria AND are a near-daily to daily user of cannabis by inhalation for greater than or equal to 6 months.
- Have documented previous diagnosis of cannabinoid hyperemesis, or
- Report (or on chart review) greater than or equal to 3 episodes of emesis in a cyclic pattern separated by greater than 1 month during the preceding 2 years, or
- The provider suspects cannabinoid hyperemesis as the primary or equally likely primary diagnosis.
Who cannot join
- Ineligible subjects include age less than 18 years, weight less than 50 kg, pregnancy, daily benzodiazepines use, prolonged QTc interval on the electrocardiogram (ECG), breastfeeding mothers, previously known allergy to or intolerance of either study drug, subjects taking drugs that are contraindicated with haloperidol or olanzapine, subjects with Parkison's Disease, subjects already taking haloperidol, olanzapine, or other antipsychotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy Saint Vincent Medical Center
Toledo, Ohio, 43608
About this study
The aim of the study is to identify which medication (haloperidol or olanzapine) is most effective in treating nausea and abdominal pain associated with cannabinoid hyperemesis using a 10-point visual analog scale with intervals of 0.5.
Read the detailed description
Subjects will be weighed, have blood drawn (~20 mL, 5 teaspoons) and analyzed (CBC w/diff, CMP, lipase, quantitative hcG (if female)), urinalysis with microscopy if indicated, urine drug screen, and an ECG as part of standard routine care for such complaint in the emergency department. After consent is obtained, subjects will then be asked to rate their baseline nausea and abdominal pain on two separate 10-cm visual analog scales (VASs) [0-10, 0.5 for minor symptoms, 10 for severe symptoms].
The subjects will be pre-randomized with a computer program by an unaffiliated person to evenly distribute participants. Envelopes will be prepared by pharmacy staff with the participant number and assigned study drug, Haloperidol 5 mg or Olanzapine 10 mg, to be ready for use when a patient is enrolled. Opaque or otherwise concealed syringes will be used to maintain blinding of the administering nurse. Using a standardized order set within the EMR, subjects will be given the assigned study drug intramuscularly, and the nurse will document "CH2O study drug administered" in the electronic medical record. The subject will be monitored with five cardiac leads and pulse oximeter after receiving the study drug. While receiving intravenous crystalloid and sips of oral rehydration solution as needed, patients again will score their nausea and abdominal pain 60 minutes after medication administration, using a parallel 10-point VAS with prior score(s) visible. At 60-120 minutes after treatment, the treating physician identifies discharge readiness or, failing that, provides further orders including any rescue antiemetics (ondansetron, prochlorperazine, promethazine, or metoclopramide recommended), fluids, or imaging deemed necessary. Lastly, if appropriate, record to the nearest minute the time the patient was deemed discharge ready. After the patient's ED visit, no further collaboration will be needed from the patient. The ED chart will be reviewed to collect data including ability to tolerate liquids PO at one hour, if abdominal imaging was ordered, time of medication administration to ED discharge, admission status, need for rescue antiemetic or analgesics. The subject's information will not be used or distributed for future research studies
Subjects, all physicians, nurses, ED pharmacists, research personnel, and the investigators, including the biostatistician, will be blinded to treatment allocation until the end of the trial. In case of emergency, the unblinding will be permitted.
- Conditions
- Cannabinoid Hyperemesis Syndrome
- Being tested
- Olanzapine 10 milligram, Haloperidol
- Medical subject headings
- Cannabinoid Hyperemesis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine 10 milligramDrug
olanzapine 10 mg IM
HaloperidolDrug
Haloperidol 5 mg IM
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol arm | Active comparator | haloperidol Receives: Drug: Haloperidol |
| Olanzapine arm | Active comparator | olanzapine Receives: Drug: Olanzapine 10 milligram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea VAS scale
nausea symptoms on a scale of 0-10 with 0 being no nausea and 10 being the worst nausea
Measured: Change from Baseline nausea before medication administration to 60-120 minutes after medication administration
vomiting
vomiting symptoms on a scale of 0-10 with 0 being no vomiting and 10 being the worst vomiting
Measured: Change from Baseline vomiting before medication administration to 60-120 minutes after medication administration
abdominal pain
VAS scale abdominal pain symptoms on a scale of 0-10 with 0 being no abdominal pain and 10 being the worst abdominal pain
Measured: Change from Baseline abdominal pain before medication administration to 60-120 minutes after medication administration
Secondary outcomes (2)
admission versus discharge
admission versus discharge
Measured: Admission versus discharge status to be determined after the patient has been reassessed for their post medication nausea, vomiting, and abdominal pain VAS score. This occurs 60-120 minutes after study drug administration.
Ability to tolerate PO
Ability to tolerate liquids by mouth, the unit is binary, yes or no
Measured: 60-120 minutes after medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start6 Nov 2025
- Primary completion25 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabinoid Hyperemesis SyndromeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Bon Secours Saint Vincent Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Jabour, Mercy Bon Secours Saint Vincent Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246187
- Sponsor's protocol ID
- 1398377
- Acronym
- CH2O
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No outside people will be involved, single center study
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department
- ClinicalTrials.gov ID
- NCT07246187
- Acronym / sponsor ID
- CH2O / 1398377
- Conditions
- Cannabinoid Hyperemesis Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mercy Bon Secours Saint Vincent Medical CenterUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 24 Nov 2025 (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 aim of the study is to identify which medication (haloperidol or olanzapine) is most effective in treating nausea and abdominal pain associated with cannabinoid hyperemesis using a 10-point visual analog scale with intervals of 0.5.
Detailed description
Subjects will be weighed, have blood drawn (~20 mL, 5 teaspoons) and analyzed (CBC w/diff, CMP, lipase, quantitative hcG (if female)), urinalysis with microscopy if indicated, urine drug screen, and an ECG as part of standard routine care for such complaint in the emergency department. After consent is obtained, subjects will then be asked to rate their baseline nausea and abdominal pain on two separate 10-cm visual analog scales (VASs) [0-10, 0.5 for minor symptoms, 10 for severe symptoms].
The subjects will be pre-randomized with a computer program by an unaffiliated person to evenly distribute participants. Envelopes will be prepared by pharmacy staff with the participant number and assigned study drug, Haloperidol 5 mg or Olanzapine 10 mg, to be ready for use when a patient is enrolled. Opaque or otherwise concealed syringes will be used to maintain blinding of the administering nurse. Using a standardized order set within the EMR, subjects will be given the assigned study drug intramuscularly, and the nurse will document "CH2O study drug administered" in the electronic medical record. The subject will be monitored with five cardiac leads and pulse oximeter after receiving the study drug. While receiving intravenous crystalloid and sips of oral rehydration solution as needed, patients again will score their nausea and abdominal pain 60 minutes after medication administration, using a parallel 10-point VAS with prior score(s) visible. At 60-120 minutes after treatment, the treating physician identifies discharge readiness or, failing that, provides further orders including any rescue antiemetics (ondansetron, prochlorperazine, promethazine, or metoclopramide recommended), fluids, or imaging deemed necessary. Lastly, if appropriate, record to the nearest minute the time the patient was deemed discharge ready. After the patient's ED visit, no further collaboration will be needed from the patient. The ED chart will be reviewed to collect data including ability to tolerate liquids PO at one hour, if abdominal imaging was ordered, time of medication administration to ED discharge, admission status, need for rescue antiemetic or analgesics. The subject's information will not be used or distributed for future research studies
Subjects, all physicians, nurses, ED pharmacists, research personnel, and the investigators, including the biostatistician, will be blinded to treatment allocation until the end of the trial. In case of emergency, the unblinding will be permitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haloperidol arm | Active comparator | Drug: Haloperidolhaloperidol |
| Olanzapine arm | Active comparator | Drug: Olanzapine 10 milligramolanzapine |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects must meet ONE of the below criteria AND are a near-daily to daily user of cannabis by inhalation for greater than or equal to 6 months.
Key exclusion criteria (1 listed)
- Ineligible subjects include age less than 18 years, weight less than 50 kg, pregnancy, daily benzodiazepines use, prolonged QTc interval on the electrocardiogram (ECG), breastfeeding mothers, previously known allergy to or intolerance of either study drug, subjects taking drugs that are contraindicated with haloperidol or olanzapine, subjects with Parkison's Disease, subjects already taking haloperidol, olanzapine, or other antipsychotics
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 |
|---|---|---|
| Olanzapine 10 milligramolanzapine 10 mg IM | Drug | Olanzapine arm |
| HaloperidolHaloperidol 5 mg IM | Drug | Haloperidol arm |
Primary outcome
Nausea VAS scale
Time frame: Change from Baseline nausea before medication administration to 60-120 minutes after medication administration
nausea symptoms on a scale of 0-10 with 0 being no nausea and 10 being the worst nausea
vomiting
Time frame: Change from Baseline vomiting before medication administration to 60-120 minutes after medication administration
vomiting symptoms on a scale of 0-10 with 0 being no vomiting and 10 being the worst vomiting
abdominal pain
Time frame: Change from Baseline abdominal pain before medication administration to 60-120 minutes after medication administration
VAS scale abdominal pain symptoms on a scale of 0-10 with 0 being no abdominal pain and 10 being the worst abdominal pain
2 secondary outcomes
admission versus discharge
Time frame: Admission versus discharge status to be determined after the patient has been reassessed for their post medication nausea, vomiting, and abdominal pain VAS score. This occurs 60-120 minutes after study drug administration.
Ability to tolerate PO
Time frame: 60-120 minutes after medication administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. No outside people will be involved, single center study
Related trials for Cannabinoid Hyperemesis Syndrome
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruitingEarly Phase 1
Haloperidol For Outpatient Symptom Management in Patients Diagnosed With Cannabinoid Hyperemesis Syndrome in the Emergrency Department
Cannabinoid Hyperemesis Syndrome
RecruitingObservational study
Cannabinoid Hyperemesis Syndrome. Prospective Multicenter Study of Patients Admitted to Adult Emergency Departments in Maine-et-Loire.
D000096704, Cannabinoid Hyperemesis Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine 10 milligram and Haloperidol in people with Cannabinoid Hyperemesis Syndrome, run by Mercy Bon Secours Saint Vincent Medical Center at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 14 Oct 2026. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea VAS scale (time frame: Change from Baseline nausea before medication administration to 60-120 minutes after medication administration). The study lists 3 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 14 Oct 2026.