NCT05307822

CSD210903: A Study to Determine Subject Puffing Patterns of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Ambulatory Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center, open-label, parallel-cohort-study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) combustible cigarette (CC) and/or a UB Heated Tobacco Product (HTP) to one of four investigational products (IPs), across two heating modes, over a 28-day ambulatory period.

Detailed description

Potential subjects may complete a pre-screening interview and will complete a Screening Visit to assess their eligibility within 28 days prior to enrollment. Based on meeting eligibility requirements, subjects will be scheduled to return to the clinic to complete Enrollment. This study will recruit adult smokers of both non-menthol and menthol combustible cigarettes, users of non-menthol and menthol HTPs, and dual users of non-menthol and menthol CCs and HTPs. To minimize bias, subjects will be assigned to either a non-menthol or menthol HTP IP flavor cohort depending upon self-reported flavor usage history. Subjects who report using non-menthol CC/HTP will be assigned to the single non-menthol HTP IP group, and subjects who report using menthol CC/HTP will be assigned to one of the three menthol HTP IP groups after optionally sampling the three menthol HTP IPs and determining which menthol product they would like to use for the length of the study. Once a particular menthol flavor group has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use UB CC or HTP during the study. At the Enrollment Visit, subjects will be provided a heating device, HTP IPs for their assigned product, a Product Use and Behavior (PUB) instrument, and an electronic device for use with the PUB instrument. The electronic device will have the PUB application installed for topography data capture and PUB data transmission. Subjects will be trained on using the heating device, connecting the PUB instrument, and using the electronic device for PUB data transmission. Based upon their self-reported UB CC and/or HTP usage, subjects will be given a sufficient amount of the assigned HTP IP. Subjects will be instructed to use the assigned HTP IP in place of UB CC and HTP, as applicable per the subject's normal product use pattern, during the 28-day study period (including a 14-day IP acclimation period followed by a 14-day product use evaluation period). Subjects will be allowed to use non-CC or non-HTP tobacco/nicotine-containing products (e.g., ENDS products (e-cigarettes), snuff, snus, chewing tobacco, modern oral pouches) according to the subject's normal use pattern. The PUB instrument will collect puffing topography data throughout the product use periods. At the end of the 14-day acclimation period of the study, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using UB CC or UB HTP and to document any AEs. During the following evaluation period (Days 15-28), subjects will receive a phone call to remind them of guidelines for using their assigned IP and to document any AEs. At the conclusion of the 28-day ambulatory period, the subjects will return to the clinic, return the heating device, HTP Accessory USB charger and accessories, all unused HTP IPs, the corresponding PUB instrument and its charger, and the electronic device and its charger. Each subject will complete all End of Study procedures including completing the Product Evaluation Scale (PES) questionnaire, two additional questionnaires to assess overall product liking and intention to use, and then subjects will be discharged from the study.

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Non-combusted cigarette variant 42001401	Menthol flavor variant of a non-combusted cigarette (42001401)
OTHER	Non-combusted cigarette variant 42001399	Menthol flavor variant of a non-combusted cigarette (42001399)
OTHER	Non-combusted cigarette variant 40007386	Menthol flavor variant of a non-combusted cigarette (40007386)
OTHER	Non-combusted cigarette variant 42001402	Non-Menthol flavor variant of a non-combusted cigarette (42001402)

Timeline

• Start date: 2022-04-21
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2022-04-01
• Last updated: 2023-03-27

Locations

7 sites across 1 country: United States