Droperidol on Prevention of Cannabis Hyperemesis Syndrome

NCT ID: NCT05244460

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2023-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cannabis Hyperemesis Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Droperidol Injectable Product

Intervention Type DRUG

Treatment

Diphenhydramine

Intervention Type DRUG

Treatment

Interventions

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Droperidol Injectable Product

Treatment

Intervention Type DRUG

Diphenhydramine

Treatment

Intervention Type DRUG

Other Intervention Names

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Inapsine Benadryl

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lake Erie College of Osteopathic Medicine

OTHER

Sponsor Role collaborator

Mercy Health Ohio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Bolotin, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Health

Locations

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Mercy Health - Austintown

Austintown, Ohio, United States

Site Status RECRUITING

St Elizabeth Boardman Hospital

Boardman, Ohio, United States

Site Status RECRUITING

St. Joseph-Warren Hospital

Warren, Ohio, United States

Site Status RECRUITING

St Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Todd Bolotin, MD

Role: CONTACT

3302193838

Quincy Chopra, MD

Role: CONTACT

4128059742

Facility Contacts

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Benjamin Pugsley, DO

Role: primary

619-972-5453

Joseph Noga, DO

Role: primary

724-944-7500

Benjamin Pugsley, DO

Role: primary

619-972-5453

Chad Donley, MD

Role: primary

330-729-7960

References

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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.

Reference Type BACKGROUND
PMID: 33160719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30729854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23583118 (View on PubMed)

Other Identifiers

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21-029

Identifier Type: -

Identifier Source: org_study_id

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