Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      A randomized, open label, 2-group, 4-period cross-over study in adult closed system ENDS
      consumers designed to evaluate puff topography parameters with use of JUUL ENDS products
      (Virginia Tobacco, Menthol, Mint, and Mango flavors, each at 5% and 3% nicotine strengths).
    

Detailed description: 
      Subjects who successfully complete screening procedures, including a brief trial with each of
      the JUUL flavors at the 5% strength, will be eligible to participate in the study.

      Subjects will be randomized into one of two (2) groups (Virginia Tobacco and Menthol or Mint
      and Mango, each at both nicotine strengths) and to one of four (4) product use sequences
      specifying the order for which they will use the assigned products.

      Apart from the final in-clinic visit, study visits will include two puff topography sessions;
      each session will be separated by 2 hours (minimum) after completion of the previous
      topography session. Puff topography sessions will include 1 hour of ad libitum product use
      according to the subject's usual ENDS product use procedures. A Baseline topography session
      will be done using the subject's usual ENDS product to provide context to the JUUL results.
      The Baseline session will be followed by a topography session with a JUUL product. Subsequent
      clinic visits will include two different JUUL products: (1) The JUUL product used during the
      current study period and (2) The JUUL product for the next study period. The final in-clinic
      visit will only include one puff topography session with the JUUL product used during the
      final study period.

      Puff topography measurements will be collected with a Clinical Research Support System
      (CReSS) device. Subjects who present with a preferred ENDS product that is not compatible
      with adapters fitting the CReSS device will participate in the 1 hour product use session
      without using the CReSS device. The weight of the product (pod/cartomizer without the
      battery; resolution of 0.1 mg) will be measured before and after use.

      Subjects will complete subjective effects questionnaires (Product Liking and PES) after
      completion of each topography session. The subjective effects questionnaires and product use
      data will be used to assess potential factors that might impact the puff topography
      parameters.

      After completion of required study events at each clinic visit, subjects will be discharged
      with a 7-day supply of the appropriate JUUL product and with instructions that the provided
      product is the only tobacco/nicotine containing product that they are to use, and to reach
      out to the clinic if it appears that they will run out of JUUL products before the next
      clinic visit. Subjects will be also be asked to complete an at-home product use log each day
      until returning to the clinic.
    

Intervention name(s): JUUL ENDS - Virginia Tobacco 5% nicotine strength; JUUL ENDS - Virginia Tobacco 3% nicotine strength; JUUL ENDS - Menthol 5% nicotine strength; JUUL ENDS - Menthol 3% nicotine strength; JUUL ENDS - Mint 5% nicotine strength; JUUL ENDS - Mint 3% nicotine strength; JUUL ENDS - Mango 5% nicotine strength; JUUL ENDS - Mango 3% nicotine strength
Intervention type(s): 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 - Menthol 5% nicotine strength; JUUL ENDS - Menthol 3% nicotine strength; JUUL ENDS - Mint 5% nicotine strength; JUUL ENDS - Mint 3% nicotine strength; JUUL ENDS - Mango 5% nicotine strength; JUUL ENDS - Mango 3% nicotine strength
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, open label, 2-group, 4-period cross-over study in adult closed system ENDS consumers designed to evaluate puff topography parameters with use of JUUL ENDS products .
Masking: None (Open Label)
Primary purpose: Other
Keywords: Topography