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This is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S. The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21 to 60 years of age, inclusive, who typically smoke on average (≥5 cigarettes/day) on at least 20 out of the past 30 days will use a heated tobacco product comprising a heating device and four non-combusted cigarette variants (HTP Investigational Product [IP]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials.
Adult smokers will be recruited, and candidate subjects who meet study inclusion criteria and none of the exclusion criteria will give verbal consent for further screening. Candidate subjects will be scheduled to attend an in-person Site Enrollment Visit. Subjects will self-report their ad libitum use of the HTP IP as well as use of combustible cigarettes (CCs) and any other tobacco- or nicotine-containing products (TNPs) on a daily basis using an electronic diary (eDiary).
During a 1-week Baseline Assessment Period (BAP), enrolled subjects will record all CC and any other TNP use in the eDiary. At the end of the BAP, subjects will return to the study site for Site Visit 1 (SV1). At this visit, subjects will be provided the HTP IP for the first two weeks of the AUP.
During the subsequent 6-week observational AUP, subjects can choose to use the HTP IP (or not). Subjects will be instructed to record all daily TNP and CC use in the eDiary. They will return to the site every two weeks during the AUP for an in-person interview, to complete questionnaires and for product accountability and resupply. As with SV1, at Site Visit 2 and 3, subjects will be able to select their preferred HTP IP variants (if desired) for use during the subsequent 2-week AUP. Point of sale materials will be present during subject interactions at SVs. After Week 6 of the AUP, there will be a final site visit and week-long Close Out Period.
In addition to collecting information on daily ad libitum use of HTP IP, TNP and CC use, the study will assess subjective measures for each HTP IP, including product use/misuse and intent to use again (at close of study). Information on intention to quit CC use will be collected at enrollment and at study conclusion. A passive surveillance mechanism will be used to collect information on adverse health experiences.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40007388 | Other | A non-combusted cigarette used with heated tobacco device 20020064 | ||
| 40007385 | Other | A non-combusted cigarette used with heated tobacco device 20020064 | ||
| 40007387 | Other | A non-combusted cigarette used with heated tobacco device 20020064 | ||
| 40007386 | Other | A non-combusted cigarette used with heated tobacco device 20020064 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Proportion of Established Users | Number and proportion of subjects who meet the definition of "established users" of the HTP IP | 6 weeks |
| Number and Proportion of Established Users who reduce their CPD consumption | Number and proportion of subjects among "established users" of the HTP IP who reduce their CPD consumption by at least 50% | 8 weeks |
| Descriptive weekly average CPD consumption | Descriptive weekly average CPD consumption per subject among all subjects who complete the study, including both established and non-established users of the HTP IP | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The study sample will comprise generally healthy, U.S. adult tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day) on at least 20 of 30 days, who are not currently quitting all Tobacco- and/or Nicotine-containing Product (TNP) use, and who have no intention of quitting all TNP use in the next three months (quitting CC use only is allowable). Once enrolled, subjects confirming an intent to quit all TNP use during the AUP will be discontinued. A recruiting target for younger smokers (21-30 years old) of approximately 15% will be established to ensure that they are sufficiently represented among the enrolled subjects.
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| Name | Affiliation | Role |
|---|---|---|
| Mandara Shetty | BAT/RAIS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schlesinger Atlanta | Atlanta | Georgia | 30328 | United States | ||
| Schlesinger Chicago |
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| Chicago |
| Illinois |
| 60611 |
| United States |
| Schlesinger Baltimore | Baltimore | Maryland | 21204 | United States |
| Schlesinger Minneapolis | Edina | Minnesota | 55439 | United States |
| Schlesinger Kansas City | Kansas City | Missouri | 64114 | United States |
| Schlesinger St. Louis | St Louis | Missouri | 63131 | United States |
| Schlesinger Charlotte | Charlotte | North Carolina | 28273 | United States |
| Schlesinger Nashville | Nashville | Tennessee | 37203 | United States |
| Schlesinger Dallas | Dallas | Texas | 75254 | United States |
| Schlesinger Houston | Houston | Texas | 77027 | United States |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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