Terbinafine Adverse ReactionNCT05667246
Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine
A study testing Caffeinated Coffee and Decaffeinated Coffee in people with Terbinafine Adverse Reaction, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Terbinafine Adverse Reaction
- What is being tested?
- Caffeinated Coffee and Decaffeinated Coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient of any gender at least 18 years of age
- Diagnosed with onychomycosis
- Planning to start oral terbinafine
Who cannot join
- Pregnant or breastfeeding
- Any history of anxiety or hypertension
- Any patient with an inability to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.
Read the 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
- Being tested
- Caffeinated Coffee, Decaffeinated Coffee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeinated CoffeeOther
Subjects would be randomized to a group "Caffeinated" and subjects will be 95 mg of caffeine in caffeinated coffee.
Decaffeinated CoffeeOther
Subjects would be randomized to a group "Decaffeinated" and subjects will be no caffeine in decaffeinated coffee.
| Study group | Role | What they receive |
|---|---|---|
| Caffeinated Group | Active comparator | Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine Receives: Other: Caffeinated Coffee |
| Decaffeinated Group | Placebo comparator | Decaffeinated coffee, 1 cup, 8 oz water setting Receives: Other: Decaffeinated Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure
An inflatable cuff will be placed around the subject's arm. The cuff has a gauge on it that will measure the blood pressure.
Measured: Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
Change in Heart Rate
A heart rate monitor will be used to measure the pulse of the subject.
Measured: Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start25 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terbinafine Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Lipner, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667246
- Sponsor's protocol ID
- 22-03024634
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2022
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine
- ClinicalTrials.gov ID
- NCT05667246
- Acronym / sponsor ID
- 22-03024634
- Conditions
- Terbinafine Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeinated Group | Active comparator | Other: Caffeinated CoffeeCaffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine |
| Decaffeinated Group | Placebo comparator | Other: Decaffeinated CoffeeDecaffeinated coffee, 1 cup, 8 oz water setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient of any gender at least 18 years of age
- Diagnosed with onychomycosis
- Planning to start oral terbinafine
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding
- Any history of anxiety or hypertension
- Any patient with an inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinated CoffeeSubjects would be randomized to a group "Caffeinated" and subjects will be 95 mg of caffeine in caffeinated coffee. | Other | Caffeinated Group |
| Decaffeinated CoffeeSubjects would be randomized to a group "Decaffeinated" and subjects will be no caffeine in decaffeinated coffee. | Other | Decaffeinated Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari Lipner, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeinated Coffee and Decaffeinated Coffee in people with Terbinafine Adverse Reaction, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure (time frame: Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.