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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.
Electronic Cigarette Use
Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS, Switch from UB of Combustible Cigarette to JU
Woodland International Research Group
Enrolling by invitation
Juul Labs, Inc.
Published on BioPortfolio: 2019-10-03T07:54:45-0400
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Genes that cause the epigenotype (i.e., the interrelated developmental pathways through which the adult organism is realized) to switch to an alternate cell lineage-related pathway. Switch complexes control the expression of normal functional development as well as oncogenic transformation.
A state bounded on the north by Pennsylvania, on the east by Delaware and the Atlantic Ocean, on the south by Virginia and West Virginia, and on the west by West Virginia.
Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.
The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.
State bounded on the north by Maryland and West Virginia, on the east by the Atlantic Ocean, the Chesapeake Bay and Maryland, and on the south by North Carolina and Tennessee, and on the west by Kentucky and West Virginia.