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Caffeine Consumption for Terbinafine Reaction
N/A
Waitlist Available
Led By Shari Lipner, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
Awards & highlights
Study Summary
This trial will test if caffeine affects blood pressure/heart rate when taking a common anti-fungal drug.
Who is the study for?
This trial is for adults over 18 with a nail infection called onychomycosis who are about to begin treatment with terbinafine. It's not open to pregnant or breastfeeding individuals, those unable to consent, or anyone with a history of anxiety or high blood pressure.Check my eligibility
What is being tested?
The study aims to see if drinking caffeinated coffee affects heart rate and blood pressure differently than decaffeinated coffee in patients taking the antifungal medication terbinafine.See study design
What are the potential side effects?
Potential side effects may include changes in heart rate and blood pressure due to caffeine consumption while on terbinafine. Other common side effects from caffeine like jitteriness, insomnia, or digestive issues might also be observed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Blood Pressure
Change in Heart Rate
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Caffeinated GroupActive Control1 Intervention
Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine
Group II: Decaffeinated GroupPlacebo Group1 Intervention
Decaffeinated coffee, 1 cup, 8 oz water setting
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,476 Total Patients Enrolled
Shari Lipner, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
3 Previous Clinical Trials
41 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with nail fungus.I am planning to start taking oral terbinafine.I am 18 years old or older.I am unable to give consent for medical procedures.I have a history of anxiety.I have a history of high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Caffeinated Group
- Group 2: Decaffeinated Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the current research protocol include participant recruitment?
"According to the information hosted on clinicaltrials.gov, this medical investigation is no longer recruiting participants, with the earliest posted date being January 1st 2023 and the most recent update taking place on December 19th 2022. Nevertheless, there are still other trials that are currently enrolling patients right now."
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