Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS
Condition: Electronic Cigarette Use; Cigarette Use, Electronic; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): 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 JUUL 3% Mint ENDS; Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDS; Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDS; Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDS; Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDS; Switch to Dual-use of JUUL 5% and UB of Combustible Cigarette; Tobacco/Nicotine Abstention; Usual Brand of cigarettes
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): JUUL 5%, ENDS for 6-days in confinement; JUUL 3%, ENDS for 6-days in confinement; JUUL 5%, ENDS for 6-days in confinement; JUUL 3%, ENDS for 6-days in confinement; JUUL 5%, ENDS for 6-days in confinement; JUUL 3%, ENDS for 6-days in confinement; JUUL 5%, ENDS for 6-days in confinement; JUUL 3%, ENDS for 6-days in confinement; Combination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement; No smoking for 6-days in confinement.; Continue smoking UB for 6-days in confinement.
Other intervention name(s): JUUL
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Open-Label, Parallel-Group
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Combustible Cigarettes; Nicotine