CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).

Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility and, based on meeting eligibility requirements, will be enrolled into the study on the same day of the Screening Visit. Once enrolled, the subjects will be randomized to either the 5.0% nicotine ENDS products or the 2.4% nicotine ENDS products. Once randomized to the nicotine level, subjects will be assigned to one of the four flavor variants based on alignment with their preferred UB flavor. Subjects will be provided an orientation to the product and the Product Use and Behavior (PUB) instrument and provided with enough cartridges (sufficient for three weeks of product use \[125% their reported weekly use of their UB\]) to last the 3-week period of the study. The subjects will take the products home and use them ad libitum for a 1-week acclimation period followed by a 2-week product use period. During this time product use will be captured by the PUB instrument and their data uploaded to the cloud regularly. At the conclusion of the 3-week ambulatory period, the subject will return to the clinic, return the ENDS power unit, used and unused ENDS cartridges, and the PUB instrument (and all cables/charger), have his/her health status reevaluated, complete the Product Evaluation Scale (PES) questionnaire and will then be discharged from the study.