Recruiting

Health Warning Labels

Sponsor:

Florida International University

Code:

NCT04907136

Conditions

Electronic Cigarette Use

Eligibility Criteria

Sex: All

Age: 21 - 35

Healthy Volunteers: Accepted

Interventions

Preferred ENDS

Preferred ENDS with HWL

Study Details

Brief summary:

In this project, after systematically developing electronic nicotine delivery systems (ENDS) pictorial health warning labels (HWLs), a proven clinical lab model will be used to examine and test their effect when these are placed on the ENDS device on a variety of subjective (e.g. satisfaction, harm perception, nicotine dependence, intention to quit) and objective outcomes (e.g. plasma nicotine, puff topography) in young adults.

Conditions

Electronic Cigarette Use

Study ID

NCT04907136

Start date

Dec 13, 2023

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Preferred ENDS

All participants will complete a lab visit where they will use their preferred ENDS ad libitum for up to 60 minutes

experimental: Preferred ENDS with HWL

All participants will complete a lab visit where they will use their preferred ENDS with a HWL on the device ad libitum for up to 60 minutes

Interventions

Preferred ENDS

Preferred ENDS without HWL on device

Preferred ENDS with HWL

Preferred ENDS with a HWL on device

Primary outcome measure

  • Plasma nicotine [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Wasim Maziak, MD, PhD

305-348-4501wmaziak@fiu.edu

Locations

Florida International University

Recruiting

Miami, Florida, United States, 33199

Contacts

Katherine Pita, BSN

786-209-9642kmpita@fiu.edu

More Information

Sponsor

Florida International University

Last update posted

Jun 5, 2026

Last verified

Mar, 2026

Keywords

  • Health Warning Labels

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida International University on 2026-06-05.