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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
71
Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
Virginia Commonwealth University
Richmond, Virginia, United States
Change in Average Daily Cigarette Use
Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Time frame: Week 1 vs. Week 6
Change in Carbon Monoxide Exposure
A biomarker of combusted cigarette use collected from exhaled breath
Time frame: Week 1 vs. Week 6
Willingness to Substitute from Cigarettes to ENDS
Measure of substitution for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced.
Time frame: Week 6
Change in Average Daily ENDS Use
Number of ENDS puffs in the past day, collected via daily text survey, averaged over the past week
Time frame: Week 1 vs. Week 6
Change in NNAL Exposure
A biomarker of combusted cigarette use collected from urine
Time frame: Week 1 vs. Week 6
Change in Proplyne Glycol Exposure
A biomarker of ENDS use collected from urine
Time frame: Week 1 vs. Week 6
Willingness to Pay for ENDS
Willingness to pay for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced.
Time frame: Week 6
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