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OpenTrials
Enrolling by Invitation

NCT Number: NCT05667246

Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

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

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeinated coffee

Other

Subjects would be randomized to a group "Caffeinated" and subjects will be 95 mg of caffeine in caffeinated coffee.

Decaffeinated coffee

Other

Subjects would be randomized to a group "Decaffeinated" and subjects will be no caffeine in decaffeinated coffee.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 28, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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