This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with two variants of HTP consumables ("sticks"), collectively referred to as the study investigational products (Study IP), among a sample of 240 primary users of combustible cigarettes in the United Kingdom (UK). Participants will be using the products for five days at home. Participants demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires. Participants will be asked to complete daily surveys using a survey link. Surveys will collect data on the number of CC smoked and number of sticks consumed the previous day in addition to any other tobacco or nicotine product used. In addition, at the end of the study, participants will complete a survey regarding overall product liking and purchase intent.
Ability to read, understand, and be willing to sign an ICF and complete questionnaires written in English.
Generally healthy male or female, between age 21-65 years (inclusive at the time of consent), verified with government-issued identification.
All female (assigned at birth) candidate participants and those who identify as "intersex" or "unknown" during screening who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
Self-report currently smoking at least five CPD on smoking days in the past 30 days.
Female participants who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next 6 months from the study start date.
Women who self-report they are not intending to use adequate contraception methods to prevent pregnancy.
Males who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they have undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children.
Individuals who self-report having pacemakers or other embedded electronic medical devices.
Parallel
P2515910
Other interventionTobacco Flavor
P2512610
Other interventionMenthol Flavor
To measure the puffing topography of primary CC smokers when using either the glo or glo plus device with one of two stick variants during a five-day use period.
The primary endpoints of this study will be measured in using built-in topography measures and the product use behavior (PUB) instrument (Study Arm 1 only). The data will include: * Mean number of puffs per day * Mean estimated puff volume (Study Arm 1) only) * Mean puff duration * Mean duration between puffs taken (inter-puff-interval; IPI) * Number of stick consumption episodes per day (as defined in the statistical analysis plan \[SAP\]
Determine the frequency of use of the glo and glo plus devices in Standard and Boost Mode
This secondary endpoint will be measured using the built-in topography measures through the Product Use Behavior (PUB) device
Determine the frequency of use of the glo plus pen detached from the charger pack (Study Arm 2 only)
This secondary endpoint will be measured using the built-in topography measures through the Product Use Behavior (PUB) device
Determine the average daily consumption (ADC) of CC smoked, sticks consumed, and other TNPs used
Through self-reported questionnaires
Determine overall product liking and purchase intent
Overall Product Liking: 1 (Strongly Dislike) - 10 (Strongly Like) Purchase Intent: 1 (Definitely would not purchase) - 10 (Definitely would purchase)
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RAI Services Company
Lead sponsor
IPSOS
Collaborator
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