Droperidol on Prevention of Cannabis Hyperemesis Syndrome (DOPE)

Mercy Health Ohio

Status and phase: Enrolling; Phase 3

Conditions: Cannabis Hyperemesis Syndrome

Treatments: Drug: Droperidol Injectable Product; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other

Identifiers

NCT05244460

21-029

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Drug: Diphenhydramine

Drug: Droperidol Injectable Product