Droperidol on Prevention of Cannabis Hyperemesis Syndrome

Phase 3

Recruiting

• Conditions: Cannabis Hyperemesis Syndrome
• Interventions: Drug: Droperidol Injectable Product; Drug: Diphenhydramine

• Registration Number: NCT05244460
• Lead Sponsor: Mercy Health Ohio

Brief Summary

The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.

Detailed Description

Patients presenting to the Emergency Department with nausea, vomiting and/or abdominal pain with a significant history of cannabis use and symptoms in a cyclic pattern will be assessed for study inclusion. After given written informed consent, patients will be treated with droperidol and diphenhydramine and symptoms will be assessed using a visual analog scale at time intervals up to 120 minutes. Patient will then be contacted at 24 and 48 hour intervals to assess symptoms on the same scale. This is a multicenter, prospective interventional study with results compared to a historical cohort using haloperidol.

Study Timeline

• Study Start: 2021-12-02
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.

Exclusion Criteria

• any patient with a contraindication to the use of droperidol
• Corrected QT interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females
• any prisoners
• pregnant females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Droperidol Injectable Product	Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once
Intervention	Diphenhydramine	Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once

Primary Outcome Measures

Name	Time	Method
Change from baseline in symptoms after treatment with droperidol and diphenhydramine	Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.	The Visual Analog Scale is a 100-mm patient-reported score measurement used to assess nausea and/or vomiting and/or abdominal pain. Possible scores range from 0 (symptom-free) to 10 (worst possible symptom)

Trial Locations

Locations (4)

Mercy Health - Austintown; 🇺🇸 Austintown, Ohio, United States

St. Joseph-Warren Hospital; 🇺🇸 Warren, Ohio, United States

St Elizabeth Youngstown Hospital; 🇺🇸 Youngstown, Ohio, United States

St Elizabeth Boardman Hospital; 🇺🇸 Boardman, Ohio, United States