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Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05667246
Recruitment Status : Not yet recruiting
First Posted : December 28, 2022
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Terbinafine Adverse Reaction Other: Caffeinated Coffee Other: Decaffeinated Coffee Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Samantha J Albucker, BA 516-425-8270 sja4002@med.cornell.edu
Contact: Shari Lipner, MD, PhD shl9032@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10021
Contact: Shari Lipner, MD,PhD       shl9032@med.cornell.edu   
Contact: Samantha J Albucker, BA    516-425-8270    sja4002@med.cornell.edu   
Principal Investigator: Shari Lipner, MD,PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Shari Lipner, MD, PhD Weill Medical College of Cornell University
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT05667246    
Other Study ID Numbers: 22-03024634
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

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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