CSD210904: Study to Assess Actual Use of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in Current Adult Smokers
Condition: Smoking; Tobacco Use; Tobacco Smoking
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): 40007388; 40007385; 40007387; 40007386
Intervention type(s): Other; Other; Other; Other
Intervention description(s): A non-combusted cigarette used with heated tobacco device 20020064; A non-combusted cigarette used with heated tobacco device 20020064; A non-combusted cigarette used with heated tobacco device 20020064; A non-combusted cigarette used with heated tobacco device 20020064
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.