Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

Study Overview
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Brief Summary
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The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

Detailed Description
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Terbinafine is a common oral medication used for moderate to severe nail onychomycosis. On the terbinafine package insert, it states that terbinafine can reduce clearance of caffeine by 19%. However, the clinical effects of this finding in patients have yet to really be studied. Decreased clearance of caffeine can physically present with measurable signs such as an increased blood pressure or increased heart rate, as well as less measurable symptoms of GI upset, irritability, headache, insomnia. As a result, dermatologists do not always know how to counsel patients taking terbinafine on their caffeine intake. Hence, recommendations vary as no studies have been done on whether caffeine consumption while taking terbinafine is associated with clinical outcomes, such as measurable changes in blood pressure or heart rate. This will be a preliminary single-blind randomized control clinical study. Patients being started on oral terbinafine by video visit will be approached for enrollment in the study. Patients will be provided with the baseline survey, to assess demographic information, BMI, and daily caffeine intake. Patients with a history of hypertension and anxiety will not be enrolled per the exclusion criteria. If the patient's blood pressure or heart rate are abnormal, they will be removed from the study We hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

Official Title
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Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

Conditions
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Terbinafine Adverse Reaction

Intervention / Treatment
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* Other: Caffeinated Coffee
* Other: Decaffeinated Coffee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient of any gender at least 18 years of age Diagnosed with onychomycosis Planning to start oral terbinafine Exclusion Criteria: Pregnant or breastfeeding Any history of anxiety or hypertension Any patient with an inability to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caffeinated Group<br>Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine | Other: Caffeinated Coffee<br>* Subjects would be randomized to a group Caffeinated and subjects will be 95 mg of caffeine in caffeinated coffee.<br>|
| Placebo Comparator: Decaffeinated Group<br>Decaffeinated coffee, 1 cup, 8 oz water setting | Other: Decaffeinated Coffee<br>* Subjects would be randomized to a group Decaffeinated and subjects will be no caffeine in decaffeinated coffee.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure | An inflatable cuff will be placed around the subject's arm. The cuff has a gauge on it that will measure the blood pressure. | Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine | 
| Change in Heart Rate | A heart rate monitor will be used to measure the pulse of the subject. | Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine |