Caffeine Consumption for Terbinafine Reaction

Overseen By Shari Lipner, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Terbinafine

Disqualifiers: Pregnancy, Anxiety, Hypertension, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how drinking coffee affects people taking terbinafine, a medicine for toenail fungus (onychomycosis). Researchers aim to determine if caffeine alters blood pressure or heart rate when combined with the medication. Participants will drink either caffeinated or decaffeinated coffee. This trial suits those planning to start oral terbinafine treatment and who do not have anxiety or high blood pressure. As an unphased trial, it offers a unique opportunity to contribute to understanding the interaction between common beverages and medications.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mixing caffeine with terbinafine might cause some problems. Terbinafine can prolong caffeine's presence in the body, potentially affecting heart rate or blood pressure.

Terbinafine itself may cause common side effects, such as headaches, upset stomachs, or skin rashes. In rare cases, it can affect the liver and lead to serious issues.

The trial aims to determine if adding caffeine changes these effects. The trial phase is labeled "Not Applicable," indicating that the safety of the treatment is still under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using caffeinated and decaffeinated coffee to explore how caffeine might affect reactions to terbinafine, a common antifungal medication. Unlike traditional treatments that focus solely on the medication itself, this trial looks at a simple dietary change—coffee consumption—as a way to potentially enhance or alter the drug's effectiveness. The unique aspect here is caffeine's potential impact on drug metabolism, which could lead to more personalized and effective treatment plans. This approach could offer a more accessible and natural method to optimize terbinafine's performance in treating fungal infections.

What evidence suggests that this trial's treatments could be effective for changes in blood pressure or heart rate?

This trial will compare the effects of caffeinated coffee with decaffeinated coffee in participants taking terbinafine. Research has shown that caffeine can impact blood pressure and heart rate, especially when combined with certain medications. Terbinafine, a common antifungal drug, might cause caffeine to remain in the body longer, potentially intensifying its effects on the heart and blood vessels. Although specific data on how this combination changes blood pressure or heart rate is not yet available, the concern exists because caffeine is known to raise these vital signs. People taking terbinafine often receive advice to limit caffeine to avoid possible side effects. ^{1 6 7 8 9}

Who Is on the Research Team?

Shari Lipner, MD,PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with nail fungus.

I am planning to start taking oral terbinafine.

Exclusion Criteria

Pregnant or breastfeeding

I am unable to give consent for medical procedures.

I have a history of anxiety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants consume either caffeinated or decaffeinated coffee and are monitored for changes in heart rate and blood pressure

1 day

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caffeinated Coffee
• Decaffeinated Coffee

Trial Overview 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.

How Is the Trial Designed?

Group I: Caffeinated Group Active Control 1 Intervention

Caffeinated coffee, 1 cup, 8 oz water setting, 95 mg caffeine

Group II: Decaffeinated Group Placebo Group 1 Intervention

Decaffeinated coffee, 1 cup, 8 oz water setting

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05667246

Clinical Effect of Caffeine Consumption in Patients Taking ... The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

2. ctv.veeva.com ctv.veeva.com/study/clinical-effect-of-caffeine-consumption-in-patients-taking-oral-terbinafine

Clinical Effect of Caffeine Consumption in Patients Taking Oral ... The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

3. mayoclinic.org mayoclinic.org/drugs-supplements/terbinafine-oral-route/description/drg-20066265

Terbinafine (oral route) - Side effects & dosage Avoid caffeine (coffee, soda, chocolate) while you are using this medicine. Terbinafine may cause caffeine to stay in your body longer than usual.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545218/

Terbinafine - StatPearls - NCBI Bookshelf - NIH Although most side effects are mild and self-limited, such as headache and gastrointestinal symptoms, taste disturbances (dysgeusia) can range from mild to ...

5. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/terbinafine

Terbinafine - an overview | ScienceDirect Topics The most frequently reported adverse events are mild and transient, including gastrointestinal symptoms (eg, diarrhea, dyspepsia, abdominal pain), liver ...

6. nhs.uk nhs.uk/medicines/terbinafine/side-effects-of-terbinafine/

Side effects of terbinafine Common side effects · Peeling or itching skin. If you're using the cream, gel or spray, try using smaller amounts or stop using it completely. · Rash · Headache.

7. drugs.com drugs.com/drug-interactions/caffeine-with-terbinafine-450-0-2161-0.html

Drug Interactions between caffeine and terbinafine Terbinafine may be hepatotoxic. Rare cases of cholestatic hepatitis and liver failure, some resulting in liver transplant or death, have been reported during ...

8. webmd.com webmd.com/drugs/2/drug-6188/terbinafine-hcl-oral/details

Terbinafine (Lamisil) - Uses, Side Effects, and More The most common side effects are a headache, diarrhea, an upset stomach, itching, nausea, and gas. Terbinafine can make you sensitive to the sun ...

9. goodrx.com goodrx.com/terbinafine/terbinafine-side-effects?srsltid=AfmBOoooKO2nYyMlhzy3ArZSUEoWMDm8_8_uLSyhnwMlD2aAyNcALTrt

10 Terbinafine Side Effects to Know When Taking Lamisil ... Terbinafine tablets may cause headache, diarrhea, and stomach pain. Long-term use may lead to liver damage. Here are 10 side effects to know about taking ...