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Completed

NCT Number: NCT04283292

Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UVA Health System

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsaicin

Drug

Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome

Other names: Zostrix

Placebo

Drug

Placebo cream that is applied once topically

Primary outcomes

  1. Time to resolution of symptoms

    Time frame: 1 day (During emergency department admission)

    Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome

Secondary outcomes

  1. Clinical improvement in pain score

    Time frame: 1 day (During emergency department admission)

    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

Other outcomes

  1. Symptom improvement at thirty days

    Time frame: 30 days (outpatient phone call)

    Follow-up phone call at thirty days to investigate any symptom improvement or change in cannabinoid usage.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2020
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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