A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System

This will be a multi-site, open-label, single-arm study to evaluate the rate of end of study (EOS) smoking abstinence of healthy adult consumers of combustible cigarettes (CC) when provided an electronic nicotine delivery system (ENDS) with a choice of multiple tobacco flavors over a 13-week study period. Outcomes from this study will be compared with those from a single tobacco-flavor comparator arm from an earlier conducted randomized controlled trial (RCT) with a similar design.

• FT25614 (Other): Tobacco SKU #1
• FT25615 (Other): Tobacco SKU #2
• FT25616 (Other): Tobacco SKU #3

Primary outcomes

• Impact of varying levels of access to tobacco flavor options [13 weeks]: To evaluate the impact of varying levels of access to Vuse ENDS tobacco flavor options on the rate of final 7-day abstinence from smoking CC among U.S. adult smokers at the end of a 13-week intervention period. The rate of final 7-day abstinence among participants with access to multiple tobacco flavor options in this study will be compared to the rate of final 7-day abstinence in the single tobacco flavor comparator arm in an RCT conducted earlier.

Secondary outcomes

• Complete Switching [13 weeks]: Analyses of complete switching (defined as being abstinent from smoking CCs as well as being an adopted user of the Study IP) between participants in this study with access to multiple tobacco flavors and the single tobacco flavor comparator arm from a RCT conducted earlier, as well as between preferred flavor groups
• Abstinence Between Flavor Groups [13 weeks]: Additional analyses will evaluate abstinence between preferred flavor groups; time to first 7-day abstinence between this study and the single tobacco flavor comparator arm from the prior study, and between preferred flavor groups within this study; reductions in CPD from baseline to end of study; and ≥50% CPD reductions between this study and the single tobacco flavor comparator arm in an RCT conducted earlier.

Other outcomes

• Topography [13 Weeks]: Puffing topography, quit attempts, descriptives of Study IP liking, intent to substitute CCs with Study IP, and intent to purchase will be summarized numerically.
• Demographics [13 Weeks]: Demographic characteristics of the study population will be tabulated and summarized numerically.
• AEs [13 Weeks]: The study will monitor any adverse events/experiences among participants using the Study IP.

Sex: All, ages: 21 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
* Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent.
* All female (assigned at birth) and those who identify as "intersex" or "unknown candidate" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at SEV that they are not pregnant or intending to become pregnant.
* Currently smoke at least 5 CC on smoking days in the past 30 days.
* Smoke CC on 15 or more of the past 30 days.
* Smoked at least 100 factory-made CC in their lifetime prior to the SEV.
* Indicate a willingness to use ENDS.
* Own and regularly use a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications or be willing to use a study-provided phone for surveys and other required study activities.
* Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.

Exclusion Criteria:

* Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
* Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the time of the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.
* Female participants who self-report not using adequate methods to prevent pregnancy.
* Persons with pacemakers or other embedded electronic medical devices fitted.
* Participants who self-report having an unstable heart condition, severe hypertension or diabetes.
* Persons who self-report they are allergic/sensitive to cosmetics or fragrances or any ingredient listed in commercial e-cigarette products.
* Participants who self-report poor physical or mental health.
* Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, or other combustible products and other oral nicotine products (tablets, gums, lozenges) on 11 or more days in the past 30 days.
* Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
* Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.
* Employee of a company that manufactures tobacco or ENDS products.
* Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.
* Have taken part in a tobacco/nicotine research study in the past 30 days.

• Melissa Tapia, Study director, RAIS Company