CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers

The AUS is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S. 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 (SEV). At the SEV, site staff will confirm eligibility, including age verification with a government-issued photo identification. Candidate subjects will review product information and will be shown physical examples of the Study IP, but will not sample the products. Those who indicate an "intention to use" the Study IP will undergo a second consent process, will be enrolled in the study, and will install and be trained on an eDiary application on their personal smartphones or site provisioned devices. During a 1-week Baseline Assessment Period (BAP, Week 0), 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 able to select up to five different Study IPs for the first two weeks of the AUP from the Study IPs available. During the subsequent 6-week observational AUP, subjects can choose to use the Study IP (or not). Subjects will be instructed to record all daily Study IP, 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 answer questionnaires and for product accountability and resupply. As with SV1, at Site Visit 2 (SV2) and Site Visit 3 (SV3), subjects will be able to select up to five IP varieties (if desired) for use during the subsequent 2-week AUP. After Week 6 of the AUP, there will be a final site visit (SV4) and week-long Close Out Period (COP). In addition to collecting information on daily ad libitum use of Study IP, TNP and CC use, the study will assess subjective measures (i.e., product assessment) for each Study IP, including product use behaviors and intent to use again (at close of study). Information on intention to quit CC will be collected at enrollment and at study conclusion. A passive surveillance mechanism will be used to collect information on adverse health experiences.