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Droperidol on Prevention of Cannabis Hyperemesis Syndrome

Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05244460
Acronym
DOPE
Enrollment
45
Registered
2022-02-17
Start date
2021-12-02
Completion date
2023-01-31
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Hyperemesis Syndrome

Brief summary

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

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.

Interventions

DRUGDroperidol Injectable Product

Treatment

DRUGDiphenhydramine

Treatment

Sponsors

Lake Erie College of Osteopathic Medicine
CollaboratorOTHER
Mercy Health Ohio
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in symptoms after treatment with droperidol and diphenhydramineBaseline, 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)

Countries

United States

Contacts

Primary ContactTodd Bolotin, MD
tbolotin@mercy.com3302193838
Backup ContactQuincy Chopra, MD
qchopra@mercy.com4128059742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026