Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine
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|ClinicalTrials.gov Identifier: NCT05667246|
Recruitment Status : Not yet recruiting
First Posted : December 28, 2022
Last Update Posted : March 17, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Terbinafine Adverse Reaction||Other: Caffeinated Coffee Other: Decaffeinated Coffee||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine|
|Estimated Study Start Date :||May 2023|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
Active Comparator: Caffeinated Group
Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine
Other: Caffeinated Coffee
Subjects would be randomized to a group "Caffeinated" and subjects will be 95 mg of caffeine in caffeinated coffee.
Placebo Comparator: Decaffeinated Group
Decaffeinated coffee, 1 cup, 8 oz water setting
Other: Decaffeinated Coffee
Subjects would be randomized to a group "Decaffeinated" and subjects will be no caffeine in decaffeinated coffee.
- Change in Blood Pressure [ Time Frame: 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 [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Patient of any gender at least 18 years of age
- Diagnosed with onychomycosis
- Planning to start oral terbinafine
- Pregnant or breastfeeding
- Any history of anxiety or hypertension
- Any patient with an inability to give consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05667246
|Contact: Samantha J Albucker, BAemail@example.com|
|Contact: Shari Lipner, MD, PhDfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicine|
|New York, New York, United States, 10021|
|Contact: Shari Lipner, MD,PhD email@example.com|
|Contact: Samantha J Albucker, BA 516-425-8270 firstname.lastname@example.org|
|Principal Investigator: Shari Lipner, MD,PhD|
|Principal Investigator:||Shari Lipner, MD, PhD||Weill Medical College of Cornell University|
|Responsible Party:||Weill Medical College of Cornell University|
|Other Study ID Numbers:||
|First Posted:||December 28, 2022 Key Record Dates|
|Last Update Posted:||March 17, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|