Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10021
- Weill Cornell Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Caffeinated Group
Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine
|
Subjects would be randomized to a group "Caffeinated" and subjects will be 95 mg of caffeine in caffeinated coffee.
|
|
Placebo Comparator: Decaffeinated Group
Decaffeinated coffee, 1 cup, 8 oz water setting
|
Subjects would be randomized to a group "Decaffeinated" and subjects will be no caffeine in decaffeinated coffee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Blood Pressure
Time Frame: Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
|
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
Time Frame: Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shari Lipner, MD, PhD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-03024634
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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