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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsaicin | Experimental | capsaicin 0.075% cream applied once topically |
|
| Placebo | Active Comparator | placebo cream applied once topically |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of symptoms | Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome | 1 day (During emergency department admission) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day (During emergency department admission) |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom improvement at thirty days | Follow-up phone call at thirty days to investigate any symptom improvement or change in cannabinoid usage. | 30 days (outpatient phone call) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Holian, PharmD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Health System | Charlottesville | Virginia | 22908 | United States |
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| ID | Term |
|---|---|
| D000096704 | Cannabinoid Hyperemesis Syndrome |
| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).
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investigational pharmacists and designated personell will the only unblinded study staff.
| Placebo | Drug | Placebo cream that is applied once topically |
|
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |