Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes
Condition: Tobacco Use
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the abuse liability of mentholated very low nicotine
      cigarettes compared to nicotine gum and usual brand cigarettes.
    

Detailed description: 
      This study will be a randomized, two-part, 3-way crossover designed to evaluate the abuse
      liability, pharmacokinetics (PK), and product use behavior associated with study products,
      including menthol VLN cigarettes, subjects' own-brand cigarettes, and nicotine polacrilex gum
      in healthy adult male and female exclusive smokers. Subjects will participate in a standard
      Screening visit and one 7-day Confined Assessment Phase, which will include a product trial
      session (Day -1), and two study parts (Part A and Part B). Following the Screening visit,
      eligible subjects will check-in to the study site on Day -1. Following the polacrilex gum
      training session, subjects will be required to abstain from nicotine- and tobacco-containing
      products for approximately 20 hours until the first product use session on Days 1 to 3; use
      of other nicotine-containing products will be prohibited throughout the study. No additional
      tobacco or nicotine products will be provided after the second product use on Days 4 to 6.

      On Day 1, subjects will be randomized to one of three product sequence groups in Part A,
      which will consist of an ad libitum product use session for each of the following study
      products for 4 hours in a randomized crossover manner (Days 1 to 3; one product per day):

      Product A: VLN menthol cigarette

      Product B: Own-brand filtered standard king size menthol cigarette

      Product C: 4 mg Nicotine polacrilex gum

      A pharmacodynamic measure ("use product again" visual analog scale (VAS)) will be
      administered at the end of each ad libitum product use period. Product use behaviors (i.e.,
      number of units consumed,duration of gum in mouth) will be collected throughout each ad
      libitum product use period. Upon completion of Part A, subjects will be randomized to one of
      three product sequence groups in Part B, which will consist of 3 study days (Days 4 to 6),
      with one product per day. Each study day will consist of: 1) Controlled Product Use Session
      (10 puffs from their own-brand cigarette or VLN menthol cigarette [maximum 3 ± 2 seconds per
      puff] at approximately 30 ± 5-second interpuff intervals, or chew the nicotine polacrilex gum
      using the "chew and park" method for 10 minutes); and 2) Uncontrolled Product Use Session (ad
      libitum use for 10 minutes). The Controlled Product Use Session and Uncontrolled Product Use
      Session will be separated by approximately 6 hours. During Part B, pharmacodynamic measures,
      pharmacokinetics (PK) , and product use behavior (Uncontrolled only) will be collected at
      various time points each day.
    

Intervention name(s): VLN menthol cigarettes (A); Usual Brand Menthol Cigarettes (B); Nicotine gum (C)
Intervention type(s): Other; Other; Drug
Intervention description(s): 0.4mg nicotine / g tobacco king size filter menthol cigarette; Usual brand king size menthol cigarettes; 4 mg nicotine gum
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In part A each subject will have the opportunity to use either their own brand cigarette, nicotine gum or VLN menthol cigarettes ad libitum for 4 hours after which they will answer a questionnaire on using the product again. In Part B the subjects will have a controlled use session with each product followed by and uncontrolled session.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Abuse liability