Tobacco Use Clinical Trial
Official title:
A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to Using JUUL Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations
A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to using JUUL Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations
Previous studies and data reported in the literature support that Electronic Nicotine
Delivery Systems (ENDS) have less toxicant exposure. This study will serve as a clinical
evaluation of exclusive-use of selected JUUL ENDS in 2 different nicotine concentrations (5%,
3%), with the purpose of gaining data to support the hypothesis that exclusive-use of JUUL
ENDS over the course of 6 days will result in a significant reduction in toxicant exposure
compared to combustible cigarettes.
This will be a randomized, open label, parallel group study in adult smokers to be conducted
at up to 5 sites in the United States. Changes in Biomarkers of Exposure (BoEs) from baseline
when using four JUUL ENDS with 2 different nicotine concentrations (5%, 3%) relative to Usual
Brand (UB) of combustible cigarettes and a study group abstaining from any tobacco/nicotine
product use will be assessed in this study. JUUL ENDS will be used either exclusively or
partially (dual-use), with subjects in the dual-use group using both JUUL 5% ENDS (choice of
Virginia Tobacco (VT), Mint, Menthol or Mango flavors) and UB of combustible cigarettes.
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