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Developing and Testing Health Warning Labels on the ENDS Device

Florida International University · with University of Miami · NCT04907136

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–35 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
80
US sites recruiting
1
Study start
December 13, 2023
Record last updated
June 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Preferred ENDS; Preferred ENDS with HWL

Conditions: Electronic Cigarette Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Florida International University

    Miami, FL 33199

    Site contact: Katherine Pita, BSN · 786-209-9642 · kmpita@fiu.edu

Study contacts (from the official record)

  • Wasim Maziak, MD, PhD · 305-348-4501 · wmaziak@fiu.edu
Developing and Testing Health Warning Labels on the ENDS Device (NCT04907136) | Bored Studies