NCT05667246

Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Terbinafine Adverse Reaction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-12-28
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States