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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
56
JUUL ENDS - Virginia Tobacco 5% nicotine strength
JUUL ENDS - Virginia Tobacco 3% nicotine strength
JUUL ENDS - Menthol 5% nicotine strength
Los Angeles Clinical Trials
Burbank, California, United States
Battelle Public Health Lab
Baltimore, Maryland, United States
Puff Topography Parameter - Puff Duration
To characterize post-acclimatization mean and total puff duration
Time frame: 29 Days
Puff Topography Parameter - Puff Volume
To characterize post-acclimatization mean and total puff volume
Time frame: 29 Days
Puff Topography Parameter - Flow Rate
To characterize post-acclimatization mean and peak puff flow rate
Time frame: 29 Days
Puff Topography Parameter - Inter-puff interval
To characterize post-acclimatization mean and total inter-puff interval
Time frame: 29 Days
Puff Topography Parameter - Number of Puffs
To characterize post-acclimatization total number of puffs
Time frame: 29 Days
Product Use - Product Weight Changes
To measure product weight changes during each puff topography session
Time frame: 29 Days
Product Use - Number of Pods Started Each Day
To measure number of pods started each day during the ambulatory period
Time frame: 29 Days
Product Use - Number of Puffs Per Day
To measure number of puffs per day during the ambulatory period
Time frame: 29 Days
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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
Subjective Measure of product liking
To assess the relationship between puff topography parameters and JUUL ENDS liking using a "Product Liking Questionnaire". Visual analogue scale with scale 0 (Not at all) to 100 (A Great Deal) in response to the instruction "Please indicate on the line below how much you liked the electronic cigarette product you used during this topography session."
Time frame: 29 Days
Subjective Measure of product evaluation
To assess the relationship between puff topography parameters and JUUL ENDS product evaluation using a "Modified Product Evaluation Scale". Scale consists of 21 questions that are categorized into four multi-item sub-scales: (1) "Satisfaction" (items 1, 2, 3, and 12); (2) "Psychological Reward" (items 4 through 8); (3) "Aversion" (items 9, 10, 16, and 18); and (4) "Relief" (item 11, 13, 14, 15, and reversed for item 20). Items 17 and 21 will be summarized individually.
Time frame: 29 Days