CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches
Condition: Smoking; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This is a two-site, open-label, randomized, 6-way 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: 
      Cigarette smokers and smokers also using smokeless tobacco products (ST) will be recruited
      into this AL study to evaluate elements of AL of four nicotine pouches compared to
      combustible cigarettes (CC) and nicotine polacrilex gum. At least one-third of the study
      population will include smokers using ST.

      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 and enrollment.

      Starting on Day 1, subjects will check-in at the clinical site to complete procedures to
      confirm eligibility. Eligible subjects will be enrolled and confined for 7 days. Subjects
      will be randomized to one of 6 product sequences (using a Williams Design) in which they will
      evaluate one IP in each of six separate Test Sessions, such that each subject will evaluate
      six IPs, including four nicotine pouch IPs, and 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).

      On Day 2 and continuing through Day 7, 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.

      On the half day prior to each respective Test Session, a Product Acclimation Period will
      allow subjects ad libitum use of the randomized IP (at least two trial uses) for product
      familiarization prior to use in the next day's Test Session. Subjects can also use their UB
      cigarettes ad libitum, until the 12-hour tobacco abstinence begins prior to each Test
      Session, as long as the minimum use requirement for randomized IP is met.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product N; Product E
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Usual Brand (UB) filtered, non-menthol or menthol cigarette; Flavor variant P1312914 of a nicotine pouch product with 4 mg of nicotine; Flavor variant P1312915 of a nicotine pouch product with 8 mg of nicotine; Flavor variant P1313014 of a nicotine pouch product with 4 mg of nicotine; Nicorette® White Ice Mint 4 mg nicotine gum; Flavor variant P1313015 of a nicotine pouch product with 8 mg of nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other