DOPE: Droperidol on Prevention of Cannabis Hyperemesis Syndrome

Sponsor

Mercy Health Ohio (Other)

Overall Status

Recruiting

CT.gov ID

NCT05244460

Collaborator

Lake Erie College of Osteopathic Medicine (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

11.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cannabis Hyperemesis Syndrome	Drug: Droperidol Injectable Product Drug: Diphenhydramine	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome

Actual Study Start Date :

Dec 2, 2021

Anticipated Primary Completion Date :

Dec 2, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once	Drug: Droperidol Injectable Product Treatment Other Names: Inapsine Drug: Diphenhydramine Treatment Other Names: Benadryl

Arm

Intervention/Treatment

Experimental: Intervention

Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once

Drug: Droperidol Injectable Product

Treatment

Other Names:

Inapsine

Drug: Diphenhydramine

Treatment

Other Names:

Benadryl

Outcome Measures

Primary Outcome Measures

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 vomitting and/or abdominal pain. Possible scores range from 0 (symptom-free) to 10 (worst possible symptom)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
QTc interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females
any prisoners
pregnant females.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Health - Austintown	Austintown	Ohio	United States	44515
2	St Elizabeth Boardman Hospital	Boardman	Ohio	United States	44512
3	St. Joseph-Warren Hospital	Warren	Ohio	United States	44484
4	St Elizabeth Youngstown Hospital	Youngstown	Ohio	United States	44501