CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers
Condition: Smoking; Tobacco Use; Tobacco Smoking
Study type: Observational

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.
    

Intervention name(s): P1012919 nicotine pouch; P1012915 nicotine pouch; P1012914 nicotine pouch; P1013315 nicotine pouch; P1013119 nicotine pouch; P1013218 nicotine pouch; P1012818 nicotine pouch; P1312915 nicotine pouch; P1312914 nicotine pouch; P1313015 nicotine pouch; P1313314 nicotine pouch; P1312815 nicotine pouch
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): P1012919, a nicotine pouch with 12 mg of nicotine; P1012915, a nicotine pouch with 8 mg of nicotine; P1012914, a nicotine pouch with 4 mg of nicotine; P1013315, a nicotine pouch with 8 mg of nicotine; P1013119, a nicotine pouch with 12 mg of nicotine; P1013218, a nicotine pouch with 10 mg of nicotine; P1012818, a nicotine pouch with 10 mg of nicotine; P1312915, a nicotine pouch with 8 mg of nicotine; P1312914, a nicotine pouch with 4 mg of nicotine; P1313015, a nicotine pouch with 8 mg of nicotine; P1313314, a nicotine pouch with 4 mg of nicotine; P1312815, a nicotine pouch with 8 mg of nicotine
Intervention MeSH terms: Nicotine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study sample will comprise approximately 1,200 generally healthy, U.S. adult tobacco
        consumer 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day) on
        at least 20 of the past 30 days, who are not currently quitting all TNP use, and who have
        no intention of quitting all TNP use in the next three months (intention of quitting CC use
        only is allowable). A recruiting target for younger smokers (21-30 years old) of
        approximately 15% will be established 15% to ensure that they are sufficiently represented
        among the enrolled subjects.