Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

Clinical Trial Details

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

After starting terbinafine, participants will be asked to avoid caffeine consumption for three weeks before a standard follow-up visit. At the end of the visit, patients will have their vitals measured.

After this visit, patients will be randomized to a group, “Decaffeinated” or “Caffeinated,” and given a corresponding cup of coffee. After the patient starts drinking the coffee, vitals will be taken again after 30 minutes and 60 minutes.

Patients will then continue to receive their standard-of-care and there will be no further study visits.

Key Eligibility:

Males and females who are at least 18 years of age, diagnosed with onychomycosis and planning to start oral terbinafine.
Participants must not be pregnant or breastfeeding, have any history of anxiety or hypertension, or be unable to give consent.

Detailed eligibility will be discussed with the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Zachary Neubauer
646-962-3376
zan4003@med.cornell.edu

Primary Investigator(s)

Shari Lipner, MD, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2203024634

ClinicalTrials.gov:

NCT05667246

Status

Open to Enrollment

Age Group

Adult

Disease

Onychomycosis