Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers
- Conditions
- Electronic Nicotine Delivery System Flavors
- Interventions
- Other: Tobacco product administration and assessment
- Registration Number
- NCT05023096
- Lead Sponsor
- Virginia Commonwealth University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 21+ years of age
- identify as Black/African American (single or multi-race)
- have used ≥5 cigarettes per day for ≥1 year
- biochemically confirmed cigarette smoking status
- regular cigarette brand is flavored to taste like menthol or mint
- ENDS use in the past 3 months
- report no intent to quit smoking in the next 6 months
- previous quit attempt using evidence-based method
- have a working mobile phone with a texting/data plan
- are willing receive phone calls/text messages and complete internet-based/online surveys related to the study.
- read and write in English
- are unwilling to use ENDS as part of the trial
- unstable or significant medical condition in the past 12 months
- report any other illegal drug use in past 30 days
- report intent to become pregnant or current pregnancy/breastfeeding
- report any other condition that may affect participant safety or not allow them to fully participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tobacco Tobacco product administration and assessment Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems Menthol+Tobacco Tobacco product administration and assessment Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from Unflavored Tobacco product administration and assessment Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
- Primary Outcome Measures
Name Time Method Change in Average Daily Cigarette Use Week 1 vs. Week 6 Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Change in Carbon Monoxide Exposure Week 1 vs. Week 6 A biomarker of combusted cigarette use collected from exhaled breath
Willingness to Substitute from Cigarettes to ENDS Week 6 Measure of substitution for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced.
- Secondary Outcome Measures
Name Time Method Change in Proplyne Glycol Exposure Week 1 vs. Week 6 A biomarker of ENDS use collected from urine
Willingness to Pay for ENDS Week 6 Willingness to pay for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced.
Change in NNAL Exposure Week 1 vs. Week 6 A biomarker of combusted cigarette use collected from urine
Change in Average Daily ENDS Use Week 1 vs. Week 6 Number of ENDS puffs in the past day, collected via daily text survey, averaged over the past week
Trial Locations
- Locations (1)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States