Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers (RVA Flavors)
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- STATUS
- Recruiting
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- End date
- Jun 15, 2024
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- participants needed
- 210
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- sponsor
- Virginia Commonwealth University
Summary
This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.
Description
Black/African American (AA) menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated electronic nicotine delivery systems (ENDS). The current study will evaluate whether ENDS flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers by performing a 3-arm, 6-week clinical trial of ENDS provision with follow-up to 30 days. Results of this work will help FDA make predictions about the impact of moving from the current regulatory market were menthol/tobacco flavored ENDS cartridges are available, to one where only tobacco or unflavored cartridges are available, in order to maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.
Details
| Condition | Electronic Nicotine Delivery System Flavors |
|---|---|
| Treatment | Tobacco product administration and assessment |
| Clinical Study Identifier | NCT05023096 |
| Sponsor | Virginia Commonwealth University |
| Last Modified on | 4 October 2022 |
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