NCT05244460

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

February 7, 2022

Last Update Submit

January 18, 2023

Conditions

Cannabis Hyperemesis Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: Droperidol Injectable ProductDrug: Diphenhydramine

Interventions

Droperidol Injectable ProductDRUG

Treatment

Also known as: Inapsine
Intervention
DiphenhydramineDRUG

Treatment

Also known as: Benadryl
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mercy Health - Austintown

Austintown, Ohio, 44515, United States

RECRUITING

St Elizabeth Boardman Hospital

Boardman, Ohio, 44512, United States

RECRUITING

St. Joseph-Warren Hospital

Warren, Ohio, 44484, United States

RECRUITING

St Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 33160719BACKGROUND

  • 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.

    PMID: 30729854BACKGROUND

  • 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.

    PMID: 23583118BACKGROUND

MeSH Terms

Conditions

Cannabinoid Hyperemesis Syndrome

Interventions

DroperidolDiphenhydramine

Condition Hierarchy (Ancestors)

Marijuana AbuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthylaminesAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Todd Bolotin, MD

    Mercy Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Bolotin, MD

CONTACT

3302193838tbolotin@mercy.com

Quincy Chopra, MD

CONTACT

4128059742qchopra@mercy.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 17, 2022

Study Start

December 2, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)