NCT04088175

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

A Randomized, Open-Label, Cross-Over Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Electronic Cigarette Use

Interventions

Type	Name	Description
OTHER	JUUL ENDS - Virginia Tobacco 5% nicotine strength	JUUL ENDS - Virginia Tobacco 5% nicotine strength
OTHER	JUUL ENDS - Virginia Tobacco 3% nicotine strength	JUUL ENDS - Virginia Tobacco 3% nicotine strength
OTHER	JUUL ENDS - Menthol 5% nicotine strength	JUUL ENDS - Menthol 5% nicotine strength
OTHER	JUUL ENDS - Menthol 3% nicotine strength	JUUL ENDS - Menthol 3% nicotine strength
OTHER	JUUL ENDS - Mint 5% nicotine strength	JUUL ENDS - Mint 5% nicotine strength
OTHER	JUUL ENDS - Mint 3% nicotine strength	JUUL ENDS - Mint 3% nicotine strength
OTHER	JUUL ENDS - Mango 5% nicotine strength	JUUL ENDS - Mango 5% nicotine strength
OTHER	JUUL ENDS - Mango 3% nicotine strength	JUUL ENDS - Mango 3% nicotine strength

Timeline

• Start date: 2019-10-28
• Primary completion: 2020-01-23
• Completion: 2020-01-23
• First posted: 2019-09-12
• Last updated: 2021-06-14

Locations

2 sites across 1 country: United States