NCT05184920

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,105 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13 nicotine pouches (Study 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. Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarette (CC) and any other tobacco- or nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). The study design is planned to address topics that FDA's Center for Tobacco Products (CTP) has identified as useful in evaluating new tobacco products.

Detailed description

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.

Conditions

• Smoking
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	P1012919 nicotine pouch	P1012919, a nicotine pouch with 12 mg of nicotine
OTHER	P1012915 nicotine pouch	P1012915, a nicotine pouch with 8 mg of nicotine
OTHER	P1012914 nicotine pouch	P1012914, a nicotine pouch with 4 mg of nicotine
OTHER	P1013315 nicotine pouch	P1013315, a nicotine pouch with 8 mg of nicotine
OTHER	P1013119 nicotine pouch	P1013119, a nicotine pouch with 12 mg of nicotine
OTHER	P1013218 nicotine pouch	P1013218, a nicotine pouch with 10 mg of nicotine
OTHER	P1012818 nicotine pouch	P1012818, a nicotine pouch with 10 mg of nicotine
OTHER	P1312915 nicotine pouch	P1312915, a nicotine pouch with 8 mg of nicotine
OTHER	P1312914 nicotine pouch	P1312914, a nicotine pouch with 4 mg of nicotine
OTHER	P1313015 nicotine pouch	P1313015, a nicotine pouch with 8 mg of nicotine
OTHER	P1313314 nicotine pouch	P1313314, a nicotine pouch with 4 mg of nicotine
OTHER	P1312815 nicotine pouch	P1312815, a nicotine pouch with 8 mg of nicotine

Timeline

• Start date: 2022-01-19
• Primary completion: 2022-04-29
• Completion: 2022-04-29
• First posted: 2022-01-11
• Last updated: 2022-06-27

Locations

10 sites across 1 country: United States