Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Conditions
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Cannabinoid Hyperemesis Syndrome

Intervention / Treatment
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* Drug: Capsaicin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |