Using a Novel Connected Device for the Collection of Puffing Topography Data for the Vuse Solo Electronic Nicotine Delivery System in a Real-World Setting: Prospective Ambulatory Clinical Study (Preprint)

Abstract

BACKGROUND Over the last decade the use of electronic nicotine delivery systems (ENDS) has been on the rise, while studies which describe how consumers use these products have been limited. Most studies related to the use of ENDS products have primarily involved study designs focused on use in a central location environment, providing only a snapshot of use behavior at a specific moment in time. The development of accurate and reliable data collection methods, generation of operational definitions for novel endpoints, and expansion of primary endpoints beyond those traditionally used for combustible cigarettes to reflect the additional complexity of ENDS use behavior may allow for a better understanding of how patterns of ENDS use change over time. OBJECTIVE The Product Use and Behavior (PUB) instrument was developed and used to capture the use of Vuse Solo in an ambulatory setting to best replicate real-world use behavior. METHODS A prospective ambulatory clinical study was performed with the PUB instrument. Participants were between the ages of 21 and 60, considered in good health, and were required to be established regular users of ENDS. A novel analytical approach was employed to define sessions of use with ENDS and to better understand use across the sample population. By combining this technology with a novel analytical approach, we were able to define sessions of use with an ENDS product. RESULTS This approach allowed us to determine traditional topography endpoints such as total puffs, mean puff duration, and inter-puff interval while also determining novel session-related endpoints including puffs per session, time between sessions, sessions per day, and session length. CONCLUSIONS Collecting topography data in an ambulatory setting and understanding product use in the context of sessions allows for a more complete understanding of ENDS use patterns. This approach to capturing and analyzing ENDS data provides a better understanding of the potential impact the use of ENDS products on public health. CLINICALTRIAL NCT04226404