Droperidol on Prevention of Cannabis Hyperemesis Syndrome (DOPE)

January 18, 2023 updated by: Mercy Health Ohio

Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Austintown, Ohio, United States, 44515
        • Recruiting
        • Mercy Health - Austintown
        • Contact:
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • St Elizabeth Boardman Hospital
        • Contact:
      • Warren, Ohio, United States, 44484
        • Recruiting
        • St. Joseph-Warren Hospital
        • Contact:
      • Youngstown, Ohio, United States, 44501
        • Recruiting
        • St Elizabeth Youngstown Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in symptoms after treatment with droperidol and diphenhydramine
Time Frame: 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)
Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Health Ohio

Collaborators

Lake Erie College of Osteopathic Medicine

Investigators

  • Principal Investigator: Todd Bolotin, MD, Mercy Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2021

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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