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
About this trial
This is an interventional treatment trial for Cannabinoid Hyperemesis Syndrome
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
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
NCT ID
NCT04283292
First Posted
February 21, 2020
Last Updated
January 15, 2021
Sponsor
University of Virginia
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
We'll reach out to this number within 24 hrs