Capsaicin for the Treatment of Cannabinoid Hyperemesis SyndromeLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Same as current
- Cannabinoid Hyperemesis Syndrome
- Phase 4
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).Masking: Double (Care Provider, Investigator)Masking Description: investigational pharmacists and designated personell will the only unblinded study staff.Primary Purpose: Treatment
- Between 18 years and 125 years
- Both males and females
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...
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.
- NCT #
- Not Provided
- Principal Investigator: Angela Holian, PharmD University of Virginia