NCT04907136 Developing and Testing Health Warning Labels on the ENDS Device
| NCT ID | NCT04907136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida International University |
| Condition | Electronic Cigarette Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-12-13 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Wasim Maziak, MD, PhD
PRINCIPAL INVESTIGATOR
Florida International University
Frequently Asked Questions
Who can join the NCT04907136 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 35 Years, studying Electronic Cigarette Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04907136 currently recruiting?
Yes, NCT04907136 is actively recruiting participants. Contact the research team at wmaziak@fiu.edu for enrollment information.
Where is the NCT04907136 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT04907136 clinical trial?
NCT04907136 is sponsored by Florida International University. The principal investigator is Wasim Maziak, MD, PhD at Florida International University. The trial plans to enroll 80 participants.