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Droperidol on Prevention of Cannabis Hyperemesis Syndrome (DOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05244460
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : February 17, 2022
Sponsor:
Collaborator:
Lake Erie College of Osteopathic Medicine
Information provided by (Responsible Party):
Mercy Health Ohio

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2, 2021
Estimated Primary Completion Date : December 2, 2022
Estimated Study Completion Date : January 31, 2023


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

Drug: Diphenhydramine
Treatment
Other Name: Benadryl




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • QTc interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females
  • any prisoners
  • pregnant females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05244460


Contacts
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Contact: Todd Bolotin, MD 3302193838 tbolotin@mercy.com
Contact: Quincy Chopra, MD 4128059742 qchopra@mercy.com

Locations
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United States, Ohio
Mercy Health - Austintown Recruiting
Austintown, Ohio, United States, 44515
Contact: Benjamin Pugsley, DO    619-972-5453    bpugsley1@mercy.com   
St Elizabeth Boardman Hospital Recruiting
Boardman, Ohio, United States, 44512
Contact: Joseph Noga, DO    724-944-7500    jnoga@mercy.com   
St. Joseph-Warren Hospital Recruiting
Warren, Ohio, United States, 44484
Contact: Benjamin Pugsley, DO    619-972-5453    bpugsley1@mercy.com   
St Elizabeth Youngstown Hospital Recruiting
Youngstown, Ohio, United States, 44501
Contact: Chad Donley, MD    330-729-7960    chad_donley1@mercy.com   
Sponsors and Collaborators
Mercy Health Ohio
Lake Erie College of Osteopathic Medicine
Investigators
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Principal Investigator: Todd Bolotin, MD Mercy Health
Publications:
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Responsible Party: Mercy Health Ohio
ClinicalTrials.gov Identifier: NCT05244460    
Other Study ID Numbers: 21-029
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Syndrome
Marijuana Abuse
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive
Diphenhydramine
Promethazine
Droperidol
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents