Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department (CH2O)

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.

Study Overview

• Status: Recruiting
• Conditions: Cannabinoid Hyperemesis Syndrome
• Intervention / Treatment: Drug: Haloperidol; Drug: Olanzapine 10 milligram

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 Type: Interventional
• Enrollment (Estimated): 114
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Joseph Jabour, DO FACEP; Phone Number: 3303476487; Email: jabourj1@gmail.com
• Study Contact Backup: Name: Amanda Gutek; Email: agutek@mercy.com

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Recruiting
      • Mercy Saint Vincent Medical Center
      • Contact: Amanda Gutek; Phone Number: 6148492288; Email: agutek@mercy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

  1. Have documented previous diagnosis of cannabinoid hyperemesis, or
  2. 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
  3. The provider suspects cannabinoid hyperemesis as the primary or equally likely primary diagnosis.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Haloperidol arm; haloperidol	Drug: Haloperidol; Haloperidol 5 mg IM
Active Comparator: Olanzapine arm; olanzapine	Drug: Olanzapine 10 milligram; olanzapine 10 mg IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea VAS scale	nausea symptoms on a scale of 0-10 with 0 being no nausea and 10 being the worst nausea	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	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	Change from Baseline abdominal pain before medication administration to 60-120 minutes after medication administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
admission versus discharge	admission versus discharge	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	60-120 minutes after medication administration

Collaborators and Investigators

• Sponsor: Mercy Bon Secours Saint Vincent Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Abuse; Cannabinoid Hyperemesis Syndrome; Organic Chemicals; Butyrophenones; Ketones; Haloperidol
• Other Study ID Numbers: 1398377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No outside people will be involved, single center study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No