Developing and Testing Health Warning Labels on the ENDS Device

Launched by FLORIDA INTERNATIONAL UNIVERSITY · May 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of special health warning labels on electronic cigarettes, also known as ENDS devices, to see how they influence young adults' feelings about using these products. Researchers have created pictorial warning labels that will be tested in a lab setting. They want to understand how these labels affect things like users' satisfaction, their perception of harm, their dependence on nicotine, and their intentions to quit using ENDS. The study also looks at actual nicotine levels in the participants' bodies and how they use the devices.

To participate, you must be a generally healthy adult aged 21 to 35 who has used ENDS in the last month but is willing to stop using them for 12 hours before each lab session. You cannot be a regular smoker or user of other tobacco products, and certain health conditions or recent illnesses may disqualify you. If you decide to join the study, you will attend lab sessions where your responses to the warning labels will be measured and analyzed. This research aims to provide valuable insights into how effective these health warnings can be in reducing electronic cigarette use among young adults.

Gender

ALL

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 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.