Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Phase 4

Completed

• Conditions: Cannabinoid Hyperemesis Syndrome
• Interventions: Drug: Placebo; Drug: Capsaicin

• Registration Number: NCT04283292
• Lead Sponsor: University of Virginia

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-25
• Study Start: 2020-12-01
• Status Verified: 2021-01
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• At least 18 years old
• Diagnosis of cannabinoid hyperemesis syndrome

Exclusion Criteria

• Patients who receive more than 2 anti-emetic therapies prior to screening for enrollment
• Patients who receive haloperidol as an anti-emetic therapy
• Pregnant women
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo cream applied once topically
Capsaicin	Capsaicin	capsaicin 0.075% cream applied once topically

Primary Outcome Measures

Name	Time	Method
Time to resolution of symptoms	1 day (During emergency department admission)	Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome

Secondary Outcome Measures

Name	Time	Method
Clinical improvement in pain score	1 day (During emergency department admission)	Clinical improvement in pain score as defined by visual analog score with a scale from 0-10 where is 0 is no pain and 10 is unbearable pain. Pain should decrease over time and this will be measure by the visual analog scale

Trial Locations

Locations (1)

UVA Health System; 🇺🇸 Charlottesville, Virginia, United States