Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Last updated: October 15, 2024
Sponsor: University of Virginia
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Placebo

Capsaicin

Clinical Study ID

NCT04283292
21957
  • Ages > 18
  • All Genders

Study Summary

This study aims to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome (condition that leads to repeated and severe bouts of vomiting).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old

  • Diagnosis of cannabinoid hyperemesis syndrome

Exclusion

Exclusion Criteria:

  • Patients who receive more than 2 anti-emetic therapies prior to screening forenrollment

  • Patients who receive haloperidol as an anti-emetic therapy

  • Pregnant women

  • Prisoners

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
December 01, 2020
Estimated Completion Date:
March 18, 2022

Study Description

Objectives:

The purpose of this study is to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome. We hypothesize that the use of topical capsaicin may provide effective symptomatic relief more quickly than conventional anti-emetic therapy alone thereby decreasing costs for continued drug therapies, repeat laboratory testing, radiographic imaging, and specialist consults.

Primary endpoint:

Time to resolution of symptoms, clinical improvement in pain score as defined by visual analog score.

Approach and methods:

Patients presenting to the UVA Emergency Department with chief complaint of nausea and vomiting who endorse cannabinoid use via inhalation or consumption. Patients 18 years of age and older will be included in the study and patients who have another clear indication for nausea/vomiting or cyclic vomiting (infection, appendicitis, pain, etc.) will be excluded. Patients who are enrolled in the study will be randomized 1:1 to treatment vs. placebo. All patients will be allowed 1L of intravenous fluids and one to two standard anti-emetics. The Investigational Drug Services team at UVA will be involved in compounding the capsaicin treatment versus placebo and drug/placebo shall remain in place for at least 30 minutes. Clinical improvement will be scored based on visual analog score for pain and assessment at hourly increments until discharge or admission.

Connect with a study center

  • UVA Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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