Droperidol on Prevention of Cannabis Hyperemesis Syndrome

Cannabis Hyperemesis Syndrome Clinical Trial

— DOPE  

Official title:

Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05244460
• Other study ID #: 21-029
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2023
• Source: Mercy Health Ohio
• Contact: Todd Bolotin, MD
• Phone: 3302193838
• Email: tbolotin[@]mercy.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Hyperemesis Syndrome
• Hyperemesis Gravidarum
• Marijuana Abuse
• Syndrome

Intervention

Drug:
• Droperidol Injectable Product
Treatment
• Diphenhydramine
Treatment

Locations

Country	Name	City	State
United States	Mercy Health - Austintown	Austintown	Ohio
United States	St Elizabeth Boardman Hospital	Boardman	Ohio
United States	St. Joseph-Warren Hospital	Warren	Ohio
United States	St Elizabeth Youngstown Hospital	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Mercy Health Ohio	Lake Erie College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hickey JL, Witsil JC, Mycyk MB. Haloperidol for treatment of cannabinoid hyperemesis syndrome. Am J Emerg Med. 2013 Jun;31(6):1003.e5-6. doi: 10.1016/j.ajem.2013.02.021. Epub 2013 Apr 10. — View Citation

Lee C, Greene SL, Wong A. The utility of droperidol in the treatment of cannabinoid hyperemesis syndrome. Clin Toxicol (Phila). 2019 Sep;57(9):773-777. doi: 10.1080/15563650.2018.1564324. Epub 2019 Feb 7. — View Citation

Ruberto AJ, Sivilotti MLA, Forrester S, Hall AK, Crawford FM, Day AG. Intravenous Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized, Controlled Trial. Ann Emerg Med. 2021 Jun;77(6):613-619. doi: 10.1016/j.annemergmed.2020.08.021. Epub 2020 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in symptoms after treatment with droperidol and diphenhydramine	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)	Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.