Evaluating Selected Constituents in the Exhaled Breath Samples
Condition: Electronic Cigarette Use; Cigarette Use, Electronic; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      An Open-Label, Multi-Center Study to Evaluate Selected Constituents in the Exhaled Breath
      Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco,
      Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors)
    

Detailed description: 
      The objective of this study is to evaluate the baseline-adjusted level of selected
      constituents in the exhaled breath sample (EBS) between the two JUUL NSPS products (5% vs 3%
      nicotine by weight) for Virginia Tobacco, Mint, Mango and Menthol flavor and to compare the
      change in absolute level of selected constituents in EBS before and after the use of JUUL
      NSPS (5% and 3% nicotine by weight; Virginia Tobacco, Mint, Mango, Menthol flavors) to the
      change in absolute level of selected constituents before and after the use of menthol and
      non-menthol cigarettes.

      Subjects will be screened for participation in the trial up to 28 days before Day 1. Along
      with screening procedures, all subjects will receive training on EBS collection procedures.
      All subjects will be further trained on the CPS using a training video and site instructions.
      Trained subjects will have the opportunity to try the JUUL NSPS.

      Eligible subjects will be scheduled for a Day 1 clinic visit. Within 24 to 48 hours prior to
      Check-in, the clinic staff will provide a courtesy phone call to subjects to remind them to
      abstain from the use of alcohol, any nicotine-containing products and mint/mentholated
      products for at least 12 hours prior and xanthines/caffeine for at least 24 hours prior to
      screening and Day 1.

      Following completion of the check-in events, including re-instruction on the EBS sample
      collection technique and CPS instructions, subjects will participate in the exhaled breath
      collection test sessions.

      Groups I - IV will complete two periods of baseline and test sample collections with a 3-hour
      break in between each period. Each period will consist of two baseline samples (the first for
      analysis of nicotine, propylene glycol and glycerin and the second for analysis of
      acetaldehyde, acrolein, benzoic acid, formaldehyde, and menthol), followed by product use,
      and then two test samples (similar to baseline). Exhaled CO will be measured before the first
      baseline sample, after the second baseline sample, before the first test sample and after the
      second test sample. Pods used during the test sessions will be weighed before and after use.

      Groups V and VI will complete only one period of baseline and test sample collections,
      consisting of two baseline sample collections and two test sample collections similar to that
      noted above.

      A follow-up phone call with subjects will be made the day after Check-out (or early
      withdrawal). Provided there are no adverse events which require further attention, the
      subject's participation in the trial will be complete.
    

Intervention name(s): JUUL ENDS 5% Virginia Tobacco; JUUL 3% Virginia Tobacco ENDS; JUUL 5% Mint ENDS; JUUL 3% Mint ENDS; JUUL 5% Menthol ENDS; JUUL 3% Menthol ENDS; JUUL 5% Mango ENDS; JUUL 3% Mango ENDS; US Cigarette, Non-menthol - Marlboro Gold King Size; US Cigarette, Menthol - Newport King Size
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): JUUL ENDS Virginia Tobacco 5% nicotine strength; JUUL ENDS Virginia Tobacco 3% nicotine strength; JUUL ENDS Mint 5% nicotine strength; JUUL ENDS Mint 3% nicotine strength; JUUL ENDS Menthol 5% nicotine strength; JUUL ENDS Menthol 3% nicotine strength; JUUL ENDS Mango 5% nicotine strength; JUUL ENDS Mango 3% nicotine strength; US Cigarette, Non-menthol - Marlboro Gold King Size; US Cigarette, Menthol - Newport King Size
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Four crossover groups and two single arm groups
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery; Combustible Cigarettes; Nicotine; Exhaled Breath