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Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Primary Purpose

Cannabinoid Hyperemesis Syndrome

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Capsaicin
Placebo
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabinoid Hyperemesis Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UVA Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Capsaicin

Placebo

Arm Description

capsaicin 0.075% cream applied once topically

placebo cream applied once topically

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2020
Last Updated
January 15, 2021
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04283292
Brief Title
Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
Official Title
Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabinoid Hyperemesis Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).
Masking
Care ProviderInvestigator
Masking Description
investigational pharmacists and designated personell will the only unblinded study staff.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capsaicin
Arm Type
Experimental
Arm Description
capsaicin 0.075% cream applied once topically
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
placebo cream applied once topically
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Other Intervention Name(s)
Zostrix
Intervention Description
Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo cream that is applied once topically
Primary Outcome Measure Information:
Title
Time to resolution of symptoms
Description
Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome
Time Frame
1 day (During emergency department admission)
Secondary Outcome Measure Information:
Title
Clinical improvement in pain score
Description
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
Time Frame
1 day (During emergency department admission)
Other Pre-specified Outcome Measures:
Title
Symptom improvement at thirty days
Description
Follow-up phone call at thirty days to investigate any symptom improvement or change in cannabinoid usage.
Time Frame
30 days (outpatient phone call)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Holian, PharmD
Phone
434-465-1981
Email
ARH6J@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Miranda West, MS
Phone
434-243-2681
Email
MW7YV@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Holian, PharmD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Holian, PharmD
Phone
434-465-1981
Email
arh6j@virginia.edu
First Name & Middle Initial & Last Name & Degree
Miranda West, MS
Email
mw7yv@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

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