Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caffeinated Coffee, Decaffeinated Coffee.
- Who it may be relevant to
- Registry conditions: Terbinafine Adverse Reaction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.
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.
Interventions
- Other Caffeinated Coffee
Subjects would be randomized to a group "Caffeinated" and subjects will be 95 mg of caffeine in caffeinated coffee. - Other Decaffeinated Coffee
Subjects would be randomized to a group "Decaffeinated" and subjects will be no caffeine in decaffeinated coffee.
Primary outcome measures
- Change in Blood Pressure [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT05667246 · 22-03024634