Status:
RECRUITING
Developing and Testing Health Warning Labels on the ENDS Device
Lead Sponsor:
Florida International University
Collaborating Sponsors:
University of Miami
Conditions:
Electronic Cigarette Use
Eligibility:
All Genders
21-35 years
Phase:
NA
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 ...
Detailed Description
The use of electronic nicotine delivery systems (ENDS or e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS emit toxic substances, including nicotine that irr...
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 current THC (marijuana) smoking/vaping.
- 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.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04907136
Start Date
December 13 2023
End Date
April 30 2026
Last Update
February 13 2025
Active Locations (1)
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1
Florida International University
Miami, Florida, United States, 33199