Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

Not Applicable

• Conditions: Terbinafine Adverse Reaction
• Interventions: Other: Caffeinated Coffee; Other: Decaffeinated Coffee

• Registration Number: NCT05667246
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-28
• Study Start: 2024-07-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffeinated Group	Caffeinated Coffee	Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine
Decaffeinated Group	Decaffeinated Coffee	Decaffeinated coffee, 1 cup, 8 oz water setting

Primary Outcome Measures

Name	Time	Method
Change in Blood Pressure	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.
Change in Heart Rate	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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States