NCT05667246

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

December 19, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

December 19, 2022

Last Update Submit

September 29, 2025

Conditions

Terbinafine Adverse Reaction

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine

Study Arms (2)

Caffeinated Group

ACTIVE COMPARATOR

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

Other: Caffeinated Coffee

Decaffeinated Group

PLACEBO COMPARATOR

Decaffeinated coffee, 1 cup, 8 oz water setting

Other: Decaffeinated Coffee

Interventions

Caffeinated CoffeeOTHER

Subjects would be randomized to a group "Caffeinated" and subjects will be 95 mg of caffeine in caffeinated coffee.

Caffeinated Group
Decaffeinated CoffeeOTHER

Subjects would be randomized to a group "Decaffeinated" and subjects will be no caffeine in decaffeinated coffee.

Decaffeinated Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient of any gender at least 18 years of age
  • Diagnosed with onychomycosis
  • Planning to start oral terbinafine

You may not qualify if:

  • Pregnant or breastfeeding
  • Any history of anxiety or hypertension
  • Any patient with an inability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Study Officials

  • Shari Lipner, MD, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2022

First Posted

December 28, 2022

Study Start

July 25, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)