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

NCT07246187 | Recruiting Phase 3 DMC

• 1 other identifier: 1398377
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cannabinoid Hyperemesis Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

  60-120 minutes after medication administration

Study Arms (2)

Haloperidol arm

ACTIVE COMPARATOR

haloperidol

Drug: Haloperidol

Olanzapine arm

ACTIVE COMPARATOR

olanzapine

Drug: Olanzapine 10 milligram

Interventions

Olanzapine 10 milligram DRUG

olanzapine 10 mg IM

Olanzapine arm

Haloperidol DRUG

Haloperidol 5 mg IM

Haloperidol arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Bon Secours Saint Vincent Medical Center: lead

Study Sites (1)

Mercy Saint Vincent Medical Center

Toledo, Ohio, 43608, United States

RECRUITING

MeSH Terms

Conditions

Cannabinoid Hyperemesis Syndrome

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Central Study Contacts

Joseph Jabour, DO FACEP

CONTACT

3303476487; jabourj1@gmail.com

Amanda Gutek

CONTACT

agutek@mercy.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Joseph Jabour DO FACEP

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)