Studying Health Warning Labels on E-Cigarette Devices

This study is looking at how health warning labels (HWLs) placed directly on electronic nicotine delivery systems (ENDS, also known as e-cigarettes) affect young adults. Researchers will compare using your preferred ENDS device without a HWL to using the same device with a HWL. They want to see how these labels impact things like your satisfaction with the device, how harmful you perceive it to be, your nicotine dependence, and your intention to quit. They will also measure objective things like the nicotine levels in your blood. You may be able to join if you are a generally healthy individual between 21 and 35 years old, use ENDS, and are willing to attend lab visits. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 80 participants. It compares two different interventions: using your preferred ENDS device without a health warning label, and using it with a health warning label.
What's involved
You will need to attend lab visits as required by the study protocol. Blood will be taken twice during each ENDS use session: once before and once after an approximately 60-minute use period.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT04907136

Developing and Testing Health Warning Labels on the ENDS Device

Recruiting
NAAges 21–35InterventionalPrevention
Florida International University
~80 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Preferred ENDSPreferred ENDS with HWL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma nicotine
Measured over During the 2 participant visits. Blood will be taken 2 times in each ENDS use session: before and after an approximately 60-min ad lib use period
Electronic Cigarette Use
1 sites across 1 states
Florida1
  • Wasim Maziak, MD, PhD · PRINCIPAL_INVESTIGATOR · Florida International University

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Eligibility criteria

Inclusion

Generally healthy individuals (determined by physical examination).
Age of 21-35 years.
Is willing to provide informed consent.
Is willing to attend the lab as required by the study protocol.
ENDS users (defined as using ENDS either daily or occasionally in the past 30 days)
Have abstained from ENDS use for 12 hours prior to each session.

Exclusion

Report smoking cigarettes regularly (\> 5 cigarettes/month in the past year).
Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
Individuals with self-reported history of chronic disease or psychiatric conditions.
Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
Individuals that report the use of non-commercial (i.e., street) e-cigarette liquid or products
Individuals that report current EVALI or COVID-19 related symptoms (i.e., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, diarrhea, fever, chills, or weight loss)
Individuals that have or have been exposed to COVID-19 in the last 14 days.
  • Plasma nicotineDuring the 2 participant visits. Blood will be taken 2 times in each ENDS use session: before and after an approximately 60-min ad lib use period

    Change in plasma nicotine level