Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
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|ClinicalTrials.gov Identifier: NCT04283292|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cannabinoid Hyperemesis Syndrome||Drug: Capsaicin Drug: Placebo||Phase 4|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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.|
|Official Title:||Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
capsaicin 0.075% cream applied once topically
Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome
Other Name: Zostrix
Active Comparator: Placebo
placebo cream applied once topically
Placebo cream that is applied once topically
- 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
- 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
- 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.
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
|Contact: Angela Holian, PharmD||434-465-1981||ARH6J@hscmail.mcc.virginia.edu|
|Contact: Miranda West, MS||434-243-2681||MW7YV@hscmail.mcc.virginia.edu|
|Principal Investigator:||Angela Holian, PharmD||University of Virginia|