Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Cannabinoid Hyperemesis Syndrome Clinical Trial

Official title:

Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283292
• Other study ID #: 21957
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: University of Virginia
• Contact: Angela Holian, PharmD
• Phone: 434-465-1981
• Email: ARH6J[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cannabinoid Hyperemesis Syndrome
• Hyperemesis Gravidarum
• Syndrome

Intervention

Drug:
• Capsaicin
Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome
• Placebo
Placebo cream that is applied once topically

Locations

Country	Name	City	State
United States	UVA Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)