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Clinical Trial Summary

This is a multi-center, open-label, parallel, three-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to the ENDS Investigational Product (IP), over a 9-day ambulatory period.

Clinical Trial Description

Potential subjects may complete a pre-screening interview and will complete a Screening Visit to assess their eligibility. Based on meeting eligibility requirements, subjects will be enrolled into the study either on the same day of their Screening Visit or return to the clinic on another day to complete the Enrollment Visit. Subjects will be assigned to one of three nicotine concentrations of the IP based on their scheduled Enrollment Visit to the clinic. Once enrolled, the subjects will be assigned to one of the flavor variants of the IP after sampling or trying flavors, within the assigned nicotine concentration, and determining which flavor that they would like to use for the length of the study. Once a particular flavor group has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use their UB ENDS products during the study. At the Enrollment Visit, subjects will be provided a Power Unit, Cartridges for their assigned product, a Product Use and Behavior (PUB) instrument, and an electronic device. The electronic device will have the PUB application installed for topography data capture and PUB data transmission. Based upon their UB ENDS usage, subjects will be given a sufficient amount of their assigned IP cartridges. Subjects will be instructed to use their assigned IP in place of their UB ENDS during the 9-day study period (including a 2-day IP acclimation period followed by a 7-day product use evaluation period). Subjects will be allowed to use non-ENDS tobacco- or nicotine-containing products according to their normal use pattern. The PUB instrument will collect puffing topography data throughout the product use period. At the end of the 2-day IP acclimation period, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using their UB ENDS. During the following Days 3-9 evaluation period, subjects will receive a phone call to remind them of guidelines for using their assigned IP and to document adverse events (AEs). At the conclusion of the 9-day ambulatory period, the subjects will return to the clinic, return the Power Unit, any associated Accessory USB Charger, all used and unused IP cartridges, the corresponding PUB instrument and its charger, and the electronic device. Each subject will complete all End of Study procedures including completing the Product Evaluation Scale (PES) questionnaire and two additional questionnaires to assess the degree of overall product liking and intention to use the product. The subjects will then be discharged from the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05118139
Study type Interventional
Source RAI Services Company
Contact John Darnell
Phone 336-741-0386
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 29, 2021
Completion date May 30, 2022

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