Using Doxepin for Urticaria

Study Overview
=================
Brief Summary
-----------------
Isolated urticaria in the emergency department is widely treated by physicians with histamine blocking agents such as diphenhydramine, cetirizine, and cimetidine. Doxepin is a tricyclic antidepressant that has been shown to have much higher concentrations of histamine blocking activity and therefore may be useful in treating urticaria. The purpose of this study is to compare the effectiveness of using doxepin verses a traditional medication, diphenhydramine (Benadryl), in the treatment of isolated urticaria in the emergency department.

Official Title
-----------------
The Use of Doxepin for Urticaria in the Emergency Department

Conditions
-----------------
Urticaria

Intervention / Treatment
-----------------
* Drug: Doxepin
* Drug: Diphenhydramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18-65 years of age Presenting to Upstate Adult Emergency Department at either the Downtown or Community campuses. Diagnosed with isolated/acute urticaria Requires treatment with antihistamines to alleviate symptoms Exclusion Criteria: Pregnant women Prisoners Patients with altered mental status/have impaired decision-making capacity. Presenting with symptoms suggesting life threatening illness or anaphylaxis. Patients who have received any antihistamine (H1 antagonist) within the past 2 hours via any route of administration. Patients who have received an H2 antagonist within the past 2 hours. Patient received steroids by any route within the past 4 hours. Patient received epinephrine within the past 20 minutes. Patients currently taking concomitant p-glycoprotein inhibitors. Patients on any of the following CYP2D6 inhibitors: Bupropion, Fluoxetine, Paroxetine, Quinidine, Tipranavir. Patients with a history of serotonin syndrome. Patients currently taking another tricyclic antidepressant, selective serotonin reuptake inhibitor, and/or serotonin-norepinephrine reuptake inhibitor. Patients who have a condition where an antihistamine may be contraindicated. Patients with a contraindication to anticholinergic medications. History of adverse effects to tricyclic antidepressants or antihistamines. Patient who, based on their medical history or in the opinion of the clinician, have chronic urticaria, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response. Patients taking antileukotriene compounds (montelukast), calcineurin inhibitors (tacrolimus) or anti-serotonin agents (cyproheptadine)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxepin<br>25mg PO one time | Drug: Doxepin<br>* 25mg dose of Doxepin will be administered one time, by mouth<br>|
| Active Comparator: Diphenhydramine<br>50mg PO one time | Drug: Diphenhydramine<br>* 50 mg dose of Diphenhydramine will be administered one time, by mouth<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of urticaria | Improvement of urticaria based on pruritis score. Scale is from 1-5, lower the score the better. | 1 hour after med administration, 2 hours after administration, and prior to discharge. | 
| Improvement of urticaria | Improvement of urticaria based percent of body area affected. Scale being utilized is the % of body area chart. | 1 hour after med administration, 2 hours after administration, and prior to discharge |