Recruiting
Phase 3

Droperidol

Sponsor:

Mercy Health Ohio

Code:

NCT05244460

Conditions

Cannabis Hyperemesis Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Droperidol Injectable Product

Diphenhydramine

Study Details

Brief summary:

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

Conditions

Cannabis Hyperemesis Syndrome

Study ID

NCT05244460

Start date

Dec 2, 2021

Status verified date

Jan, 2023

Completion date

Jan 31, 2023

Anticipated

Primary completion date

Jan 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

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

Interventions

Droperidol Injectable Product

Treatment

Diphenhydramine

Treatment

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Todd Bolotin, MD

3302193838tbolotin@mercy.com

Quincy Chopra, MD

4128059742qchopra@mercy.com

Locations

Mercy Health - Austintown

Recruiting

Austintown, Ohio, United States, 44515

Contacts

Benjamin Pugsley, DO

619-972-5453bpugsley1@mercy.com

St Elizabeth Boardman Hospital

Recruiting

Boardman, Ohio, United States, 44512

Contacts

Joseph Noga, DO

724-944-7500jnoga@mercy.com

St. Joseph-Warren Hospital

Recruiting

Warren, Ohio, United States, 44484

Contacts

Benjamin Pugsley, DO

619-972-5453bpugsley1@mercy.com

St Elizabeth Youngstown Hospital

Recruiting

Youngstown, Ohio, United States, 44501

Contacts

Chad Donley, MD

330-729-7960chad_donley1@mercy.com

More Information

Sponsor

Mercy Health Ohio

Last update posted

Jan 20, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercy Health Ohio on 2023-01-20.