Clinical trial NCT04283292: Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
Official title: Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cannabinoid Hyperemesis Syndrome
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to resolution of symptoms
timeFrame: 1 day (During emergency department admission)
Secondary outcomes:
measure: Clinical improvement in pain score
timeFrame: 1 day (During emergency department admission)
Other outcomes:
measure: Symptom improvement at thirty days
timeFrame: 30 days (outpatient phone call)
Locations:
city: Charlottesville
country: United States
facility: UVA Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Angela Holian, PharmD
role: PRINCIPAL_INVESTIGATOR
References: