Testing health warning labels on e-cigarettes

Developing and Testing Health Warning Labels on the ENDS Device

This study is testing new health warning labels on e-cigarettes to see if they can change how young adults feel about using them and help them think about quitting.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 21 Years to 35 Years
• Sex: All
• Sponsor: Florida International University (other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT04907136 on ClinicalTrials.gov

What this trial studies

This project aims to develop and test pictorial health warning labels (HWLs) for electronic nicotine delivery systems (ENDS) to assess their impact on young adult users. The study will utilize a clinical lab model to evaluate both subjective outcomes, such as satisfaction and intention to quit, and objective measures, including plasma nicotine levels. The research will involve a systematic approach, starting with literature review and expert feedback to create candidate HWLs, followed by focus groups with young ENDS users to refine these labels. Ultimately, the study seeks to understand how these labels can influence perceptions and behaviors related to ENDS use among young adults.

Who should consider this trial

Good fit: Ideal candidates for this study are generally healthy young adults aged 21-35 who are current users of ENDS.

Not a fit: Patients who smoke cigarettes regularly or use other tobacco products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective health communication strategies that reduce e-cigarette use among young adults.

How similar studies have performed: Other studies have shown that health warning labels can influence smoking behaviors, suggesting potential success for this approach.

Eligibility 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.

Where this trial is running

Miami, Florida

• Florida International University — Miami, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Wasim Maziak, MD, PhD — Florida International University
• Study coordinator: Wasim Maziak, MD, PhD

Conditions: Electronic Cigarette Use, Health Warning Labels