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

52 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Caffeinated Coffee, Decaffeinated Coffee for Terbinafine Reaction?

Caffeine has been shown to inhibit the growth of certain fungi and reduce allergen production, which might suggest a potential benefit in managing reactions related to fungal infections. ^{1 2 3 4 5}

Is caffeine generally safe for human use?

Caffeine is generally safe for human use, but excessive amounts can lead to poisoning, as seen in a case where a large amount was applied to the skin. Normal consumption through coffee is not a major health risk, although it can interfere with certain tests. ^{1 5 6 7 8}

How does caffeine consumption differ from other treatments for terbinafine reaction?

Caffeine consumption is unique because it may prevent the production of harmful compounds like ochratoxin A (OTA) by inhibiting the growth of certain fungi, which is not a typical mechanism for treating reactions to terbinafine. This approach is novel compared to standard treatments, which usually focus on managing symptoms rather than preventing fungal growth. ^{1 2 9 10 11}

What is the purpose of this trial?

This trial studies if drinking caffeine while taking terbinafine for nail fungus affects heart rate or blood pressure. Terbinafine can make caffeine stay in the body longer, possibly causing these changes.

Research Team

Shari Lipner, MD,PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Caffeine as main interfering compound in radioimmunoassay of aflatoxin B1 in coffee samples. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Stability of ochratoxin A (OTA) during processing and decaffeination in commercial roasted coffee beans. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Response Surface Optimization for Decaffeination and Theophylline Production by Fusarium solani. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Caffeine, a naturally occurring acaricide. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Percutaneous caffeine poisoning (author's transl)]. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Ochratoxin A (OTA) in coffee: nation-wide evaluation of data collected by German Food Control 1995-1999. [2012]

7. Netherlands pubmed.ncbi.nlm.nih.gov

An OECD TG 428 study ring trial with 14C-Caffeine demonstrating repeatability and robustness of the dermal absorption in vitro method. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Survey of ochratoxin A in UK retail coffees. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Anti-genotoxicity and glutathione S-transferase activity in mice pretreated with caffeinated and decaffeinated coffee. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A reproduction/teratology study of brewed and instant decaffeinated coffees. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Mutagenic activity of caffeinated and decaffeinated coffee. [2013]