Cannabinoid Hyperemesis Syndrome
Conditions
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.
Interventions
DRUGCapsaicin
Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome
DRUGPlacebo
Placebo cream that is applied once topically
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
investigational pharmacists and designated personell will the only unblinded study staff.
Intervention model description
Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to resolution of symptoms | 1 day (During emergency department admission) | Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement in pain score | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptom improvement at thirty days | 30 days (outpatient phone call) | Follow-up phone call at thirty days to investigate any symptom improvement or change in cannabinoid usage. |
Countries
United States
Outcome results
None listed