Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

NCT ID: NCT05667246

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2026-12-31

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.

Conditions

Terbinafine Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Caffeinated Group

Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine

Group Type: ACTIVE_COMPARATOR

Caffeinated Coffee

Intervention Type: OTHER

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

Decaffeinated Group

Decaffeinated coffee, 1 cup, 8 oz water setting

Group Type: PLACEBO_COMPARATOR

Decaffeinated Coffee

Intervention Type: OTHER

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

Interventions

Caffeinated Coffee

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

Intervention Type: OTHER

Decaffeinated Coffee

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shari Lipner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

22-03024634

Identifier Type: -

Identifier Source: org_study_id