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Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283292
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Angela Holian, University of Virginia

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).

Condition or disease Intervention/treatment Phase
Cannabinoid Hyperemesis Syndrome Drug: Capsaicin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).
Masking: Double (Care Provider, Investigator)
Masking Description: investigational pharmacists and designated personell will the only unblinded study staff.
Primary Purpose: Treatment
Official Title: Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Capsaicin
capsaicin 0.075% cream applied once topically
Drug: Capsaicin
Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome
Other Name: Zostrix

Active Comparator: Placebo
placebo cream applied once topically
Drug: Placebo
Placebo cream that is applied once topically




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283292


Contacts
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Contact: Angela Holian, PharmD 434-465-1981 ARH6J@hscmail.mcc.virginia.edu
Contact: Miranda West, MS 434-243-2681 MW7YV@hscmail.mcc.virginia.edu

Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Angela Holian, PharmD University of Virginia
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Responsible Party: Angela Holian, Emergency Medicine Clinical Pharmacist, University of Virginia
ClinicalTrials.gov Identifier: NCT04283292    
Other Study ID Numbers: 21957
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Syndrome
Disease
Pathologic Processes
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs