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Droperidol on Prevention of Cannabis Hyperemesis Syndrome (DOPE)

Primary Purpose

Cannabis Hyperemesis Syndrome

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Droperidol Injectable Product
Diphenhydramine
Sponsored by
Mercy Health Ohio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Hyperemesis Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mercy Health - AustintownRecruiting
  • St Elizabeth Boardman HospitalRecruiting
  • St. Joseph-Warren HospitalRecruiting
  • St Elizabeth Youngstown HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 7, 2022
Last Updated
January 18, 2023
Sponsor
Mercy Health Ohio
Collaborators
Lake Erie College of Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05244460
Brief Title
Droperidol on Prevention of Cannabis Hyperemesis Syndrome
Acronym
DOPE
Official Title
Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mercy Health Ohio
Collaborators
Lake Erie College of Osteopathic Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Hyperemesis Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once
Intervention Type
Drug
Intervention Name(s)
Droperidol Injectable Product
Other Intervention Name(s)
Inapsine
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Intervention Description
Treatment
Primary Outcome Measure Information:
Title
Change from baseline in symptoms after treatment with droperidol and diphenhydramine
Description
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)
Time Frame
Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Bolotin, MD
Phone
3302193838
Email
tbolotin@mercy.com
First Name & Middle Initial & Last Name or Official Title & Degree
Quincy Chopra, MD
Phone
4128059742
Email
qchopra@mercy.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Bolotin, MD
Organizational Affiliation
Mercy Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Health - Austintown
City
Austintown
State/Province
Ohio
ZIP/Postal Code
44515
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Pugsley, DO
Phone
619-972-5453
Email
bpugsley1@mercy.com
Facility Name
St Elizabeth Boardman Hospital
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Noga, DO
Phone
724-944-7500
Email
jnoga@mercy.com
Facility Name
St. Joseph-Warren Hospital
City
Warren
State/Province
Ohio
ZIP/Postal Code
44484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Pugsley, DO
Phone
619-972-5453
Email
bpugsley1@mercy.com
Facility Name
St Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Donley, MD
Phone
330-729-7960
Email
chad_donley1@mercy.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33160719
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.
Results Reference
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PubMed Identifier
30729854
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.
Results Reference
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PubMed Identifier
23583118
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.
Results Reference
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Droperidol on Prevention of Cannabis Hyperemesis Syndrome

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