Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

University of Virginia

Status and phase: Completed; Phase 4

Conditions: Cannabinoid Hyperemesis Syndrome

Treatments: Drug: Capsaicin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04283292

21957

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Capsaicin

Experimental group

Description:

capsaicin 0.075% cream applied once topically

Treatment:

Drug: Capsaicin

Placebo

Active Comparator group

Description:

placebo cream applied once topically

Treatment:

Drug: Placebo