CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting

Smoking Clinical Trial

Official title: CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting

Status Completed

Clinical Trial Summary

This study will be a single-center, controlled, open-label, parallel two-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 one of two different ENDS, Product A with 1.5% nicotine, and Product B with 3.0% nicotine, over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

Clinical Trial Description

Potential subjects may complete a pre-screening interview (by phone) and will complete a Screening Visit to assess their eligibility. Based on meeting eligibility requirements, it is desirable that subjects will be enrolled into the study on the same day of their Screening Visit. However, because of delays in receiving clinical laboratory test results, additional time may be needed to complete Enrollment. It may be necessary that subjects will need to return to the clinic on another day to compete Enrollment.

To minimize bias, subjects will be assigned to either Product A or Product B based on the scheduled visit to the clinic during Screening and Enrollment. Subjects will then be assigned to one of the seven e-liquid flavor variants for either Product A or Product B. Subjects will be allowed to sample or try flavors and determine which flavor that they would like to use for the length of the study.

At the Screening/Enrollment visit, subjects will be provided an orientation to the product, including the power unit and cartridges for their assigned product, and the corresponding Product Use and Behavior (PUB) instrument, PUB application, and an electronic device provided by the Sponsor. Based upon their UB ENDS usage, they will be given a sufficient amount (for three weeks of ad libitum use equaling 375% of their self-reported UB reported weekly use) of their assigned Product A or Product B cartridges.

The study will involve a one-week acclimation period followed by a two-week product use evaluation period. Subjects will be instructed to use their assigned Product A or Product B product in place of their UB ENDS during the three-week study period, but they will be allowed to use non-ENDS tobacco/nicotine-containing products according to their normal use pattern. The PUB instrument will collect topography data, and product use data will be uploaded frequently using a web-based PUB application installed on the electronic device provided by the Sponsor.

At the end of the first week of the study, subjects will receive a phone call from the clinic to assess Investigational Product (IP) compliance and to ensure that they are not using their UB ENDS. Throughout the study, subjects will receive weekly phone calls at a minimum to remind them of guidelines for using their assigned IP. All used cartridges may be disposed of by the subject.

At the conclusion of the three-week ambulatory period, the subjects will return to the clinic, return the Product A or Product B power unit, any associated USB charger, all unused IP cartridges, the corresponding PUB instrument and its charger, and the provided electronic device. Each subject will complete all End of Study procedures including completing the Product Evaluation Scale (PES) questionnaire, and then subjects will be discharged from the study. ;

Related Conditions & MeSH terms

• Smoking
• Smoking Behaviors
• Tobacco Smoking
• Tobacco Use

• NCT number: NCT04308434
• Study type: Interventional
• Source: RAI Services Company
• Status: Completed
• Phase: N/A
• Start date: May 26, 2020
• Completion date: October 22, 2020