CSD201201: Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12
Condition: Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate
      elements of abuse liability (AL) including subjective effects and physiological measures
      (pharmacodynamics [PD]), and nicotine uptake (pharmacokinetics [PK]) during and following ad
      libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs)
      in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
    

Detailed description: 
      The study will evaluate elements of AL of ENDS IPs against CC and nicotine polacrilex gum in
      generally healthy menthol CC smokers of and dual users of CC and ENDS in a confinement
      setting.

      Potential subjects will complete a pre-screening interview and a Screening Visit to assess
      eligibility within 45 days prior to enrollment, randomization and confinement.

      Starting on Study Day 1, eligible subjects will be randomized to 1 of 6 IP use sequences
      (based on a Williams Design) and will be confined at the clinical site for 8 days and 7
      nights to complete the study.

      On Day 3 and continuing through Day 8, subjects in each arm will participate in six separate
      Test Sessions, one for each IP, that will last for approximately 4 hours following the start
      of IP use. During each Test Session, subjects will use one of the six IPs: four ENDS IPs, a
      high-AL comparator (subject's UB cigarette) and a low-AL comparator (a commercially available
      nicotine gum for nicotine replacement therapy), based on the assigned IP use sequences. ENDS
      IP cartridges will be weighed prior to and after product use in the Test Session. Each Test
      Session will include collection of both PD measures (subjective and physiological) and PK
      measures prior to, during, and following IP use.

      Subjects will acclimate to the assigned products prior to each Test Session. On Study Day 1
      (Pre-study Product Acclimation Period), subjects will use each of five IPs (four ENDS IPs and
      one nicotine gum) at least once. In addition, on the half day prior to each respective Test
      Session (Starting on Day 2), subjects will participate in a Product Acclimation Period in
      which they will use the randomized IP (to be tested during the following day's Test Session,
      to include ENDS or nicotine gum) at least four times . Subjects will have access to UB
      cigarette for ad libitum use at any time during Pre-Study Product Acclimation period and
      Product Acclimation Periods as long as they meet the IP acclimation criteria. At the end of
      each Product Acclimation Period, there will be a required 12-hour abstinence period from use
      of tobacco/nicotine containing products prior to the Test Session the following day. The
      study will complete when all six IPs have been tested.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E; Product N
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Usual Brand (UB) filtered, menthol combustible cigarette; Flavor variant P1211216 of a 1.5% nicotine ENDS product; Flavor variant P1211217 of a 2.4% nicotine ENDS product; Flavor variant P1211222 of a 5.0% nicotine ENDS product; Flavor variant P1213616 of a 1.5% nicotine ENDS product; Nicorette® White Ice Mint 4 mg nicotine gum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other