Developing and Testing Health Warning Labels on the ENDS Device
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
| Condition(s) | Electronic Cigarette Use |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 ca |
| Ages | 21 Years to 35 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Florida International University |
| Locations | Miami, Florida, United States |
| Start date | 2023-12-13 |
| NCT ID | NCT04907136 |
| Official listing | https://clinicaltrials.gov/study/NCT04907136 |