This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with three variants of HTP consumables ("sticks,"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location testing (CLT) facility in the United Kingdom (UK). Puffing topography at the CLT will be measured using a desktop puffing analyzer device (PA1). In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires. Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices (glo and glo plus), with three variants of HTP consumables ("sticks," under the brand name "virto"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location testing (CLT) facility in the United Kingdom (UK). Puffing topography at the CLT will be measured using a desktop puffing analyzer device (PA1). In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires. Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors. To account for respondent drop-out, the fieldwork team will recruit approximately 15% more participants for the CLT and approximately 20% more participants to the HUT phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
212
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
Channing Hall
Sheffield, United Kingdom
To measure the puffing topography of primary combustible cigarette smokers when using either of the investigational HTP devices with one of three stick variants during CLT.
The primary endpoints will be measured in CLT using a desktop PA1. The data will be summarized using the overall mean per study arm (Study IP device) as well as mean per stick variant within arms.
Time frame: 90 minutes
To determine the average daily consumption of sticks during HUT.
Participants will be asked to log the number of sticks used during the 5-day home use testing period.
Time frame: 5 days
To assess purchase intent for participants using each of the study products before and after using the products.
Participants will be asked before and after using the product how likely they are to purchase the product on a scale from 1 to 10.
Time frame: Through study completion
To describe subjective characteristics associated with product use, including overall liking
Participants will be asked their overall liking of the product on a 1-10 scale.
Time frame: At study completion
To assess risk perceptions before using the products only.
Utilization of Tobacco Product Perception and Intentions (TPPI) survey data to understand the likelihood of certain tobacco and nicotine related use behaviors.
Time frame: Baseline
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