Clinical trial NCT05244460: Droperidol on Prevention of Cannabis Hyperemesis Syndrome
Official title: Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cannabis Hyperemesis Syndrome
Lead sponsor: Mercy Health Ohio
Sponsor class: OTHER
Collaborators: name: Lake Erie College of Osteopathic Medicine
First posted: 2022-02-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in symptoms after treatment with droperidol and diphenhydramine
timeFrame: Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Austintown
country: United States
facility: Mercy Health - Austintown
state: Ohio
city: Boardman
country: United States
facility: St Elizabeth Boardman Hospital
state: Ohio
city: Warren
country: United States
facility: St. Joseph-Warren Hospital
state: Ohio
city: Youngstown
country: United States
facility: St Elizabeth Youngstown Hospital
state: Ohio
Study officials:
affiliation: Mercy Health
name: Todd Bolotin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.