Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

Weill Cornell Medicine (WCM)

Status: Invitation-only

Conditions: Terbinafine Adverse Reaction

Treatments: Other: Decaffeinated Coffee; Other: Caffeinated Coffee

Study type: Interventional

Funder types: Other

Identifiers

NCT05667246

22-03024634

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups, including a placebo group

Caffeinated Group

Active Comparator group

Description:

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

Treatment:

Other: Caffeinated Coffee

Decaffeinated Group

Placebo Comparator group

Description:

Decaffeinated coffee, 1 cup, 8 oz water setting

Treatment:

Other: Decaffeinated Coffee