Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

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).

Study Overview

• Status: Recruiting
• Conditions: Cannabinoid Hyperemesis Syndrome
• Intervention / Treatment: Drug: Capsaicin; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Angela Holian, PharmD; Phone Number: 434-465-1981; Email: ARH6J@hscmail.mcc.virginia.edu
• Study Contact Backup: Name: Miranda West, MS; Phone Number: 434-243-2681; Email: MW7YV@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • UVA Health System
      • Contact: Angela Holian, PharmD; Phone Number: 434-465-1981; Email: arh6j@virginia.edu
      • Contact: Miranda West, MS; Email: mw7yv@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsaicin; capsaicin 0.075% cream applied once topically	Drug: Capsaicin; Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome; Other Names: Zostrix
Active Comparator: Placebo; placebo cream applied once topically	Drug: Placebo; Placebo cream that is applied once topically

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement in pain score	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	1 day (During emergency department admission)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom improvement at thirty days	Follow-up phone call at thirty days to investigate any symptom improvement or change in cannabinoid usage.	30 days (outpatient phone call)

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Angela Holian, PharmD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Signs and Symptoms, Digestive; Pregnancy Complications; Morning Sickness; Vomiting; Syndrome; Hyperemesis Gravidarum; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: 21957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No