Recruiting
Phase 3

Haloperidol vs. Olanzapine

Sponsor:

Mercy Bon Secours Saint Vincent Medical Center

Code:

NCT07246187

Conditions

Cannabinoid Hyperemesis Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Olanzapine 10 milligram

Haloperidol

Study Details

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

Study ID

NCT07246187

Start date

Nov 6, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Haloperidol arm

haloperidol

active comparator: Olanzapine arm

olanzapine

Interventions

Olanzapine 10 milligram

olanzapine 10 mg IM

Haloperidol

Haloperidol 5 mg IM

Primary outcome measure

  • Nausea VAS scale [ Time Frame: Change from Baseline nausea before medication administration to 60-120 minutes after medication administration ]
  • vomiting [ Time Frame: Change from Baseline vomiting before medication administration to 60-120 minutes after medication administration ]
  • abdominal pain [ Time Frame: Change from Baseline abdominal pain before medication administration to 60-120 minutes after medication administration ]

Central Contacts and Locations

Central contacts

Joseph Jabour, DO FACEP

3303476487jabourj1@gmail.com

Amanda Gutek

agutek@mercy.com

Locations

Mercy Saint Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43608

Contacts

Amanda Gutek

6148492288agutek@mercy.com

More Information

Sponsor

Mercy Bon Secours Saint Vincent Medical Center

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercy Bon Secours Saint Vincent Medical Center on 2025-11-24.