Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

NCT ID: NCT04283292

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-03-18

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.

Conditions

Cannabinoid Hyperemesis Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Capsaicin

capsaicin 0.075% cream applied once topically

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DRUG

Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome

Placebo

placebo cream applied once topically

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo cream that is applied once topically

Interventions

Capsaicin

Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome

Intervention Type: DRUG

Placebo

Placebo cream that is applied once topically

Intervention Type: DRUG

Other Intervention Names

Zostrix

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Angela Holian

Emergency Medicine Clinical Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Holian, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

UVA Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

21957

Identifier Type: -

Identifier Source: org_study_id