CSD200907: A Study to Assess Elements of Abuse Liability for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants
Condition: Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This is a single-center, open-label, randomized, 2-arm, within-arm cross-over study designed
      to evaluate elements of abuse liability (AL) including subjective effects and physiological
      measures (pharmacodynamics [PD]), and plasma nicotine uptake (pharmacokinetics [PK]) during
      and following ad libitum use of the study investigational products (IPs) by generally healthy
      smokers.
    

Detailed description: 
      Smokers of both non-menthol and menthol combustible cigarettes (CC) will be recruited into
      this AL study to evaluate elements of AL of four heated tobacco products (HTP) (hereinafter,
      HTP investigational products [IPs]) compared to combustible cigarette (CC) and nicotine
      polacrilex gum.

      Potential subjects may complete a pre-screening telephone interview. They will complete a
      Screening Visit to assess their eligibility within 45 days prior to check-in (inclusive of
      enrollment/randomization) and to determine their assignment to either Study Arm 1
      (non-menthol smokers) or Study Arm 2 (menthol smokers). Enrollment and clinical conduct for
      each of the two Study Arms will occur sequentially.

      Starting on Day 1, subjects will check-in at the study site to complete procedures to confirm
      eligibility. Eligible subjects will be enrolled into the appropriate Study Arm and confined
      for either 11 days (Study Arm 1) or 13 days (Study Arm 2). Based on their Study Arm
      assignment, subjects will be randomized to a product use sequence (using a Williams Design)
      in which they will evaluate one IP in each Test Session, including both a high-AL comparator
      (subject's usual brand [UB] cigarette) and a low-AL comparator (a commercially available
      nicotine replacement therapy [NRT] nicotine gum). In addition to the AL-comparators, Study
      Arm 1 will evaluate three HTP IPs (i.e., 5 Test Sessions) and Study Arm 2 will evaluate four
      HTP IPs (i.e., 6 Test Sessions).

      On Day 1 and continuing through Day 11 (Study Arm 1) or Day 13 (Study Arm 2), subjects will
      participate in Test Sessions that will last for approximately 4 hours. Each Test Session will
      include collection of both PD measures (subjective and physiological) and PK measures prior
      to, during and following IP use.

      There will be a 1.5-day Product Acclimation Period prior to each Test Session. During the
      Product Acclimation Period, subjects will be permitted ad libitum use of randomized IP for
      familiarization prior to use in the next Test Session, as well as ad libitum smoking of their
      UB cigarettes.
    

Intervention name(s): Product A1; Product B; Product C; Product D; Product A2; Product E; Product F; Product G; Product H; Product N
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Usual Brand (UB) filtered, non-menthol cigarette; 40007388, A Non-Combusted Cigarette Variant and product use Mode A; 40007388, A Non-Combusted Cigarette Variant and product use Mode B; 40007386, A Non-Combusted Cigarette Variant and product use Mode B; Usual Brand (UB) filtered, menthol cigarette; 40007385, A Non-Combusted Cigarette Variant and product use Mode A; 40007385, A Non-Combusted Cigarette Variant and product use Mode B; 40007387, A Non-Combusted Cigarette Variant and product use Mode B; 40007386, A Non-Combusted Cigarette Variant and product use Mode B; Nicorette® White Ice Mint 4 mg nicotine gum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other