Addiction and Behavior Related to Menthol Cigarette Substitutes
Condition: Smoking (Tobacco) Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The goal of the proposed study is to examine the abuse liability and substitutability of
      plausible menthol cigarette alternatives currently on the market, including menthol filtered
      little cigars (mFLC), menthol roll-your-own (mRYO) pipe tobacco and cigarette tubes, and
      non-menthol cigarettes (nmC). In addition, the study will elucidate real-time mechanisms
      including product characteristics and perceived effects associated with greater substitution.
    

Detailed description: 
      Using an in-laboratory and ad libitum outpatient mixed design, 80 current menthol cigarette
      smokers will complete a three phase, 3 week study: in Phase 1, utilizing a randomized
      crossover design, participants will complete 5 smoking sessions, each session smoking a
      different product examining each participants puff topography while sampling the product, the
      products' ability to suppress nicotine craving/withdrawal, and the product's demand indices.
      Products will include participants usual brand menthol cigarette (UBMC) as well as 3
      commercially-available alternatives, including an mFLC, a pre-assembled mRYO product (menthol
      tobacco and non-menthol tube), and an nmC. All sessions will occur following 12 hours of
      nicotine abstinence and be separated by 48 hours. In Phase 2, participants will select their
      preferred study product from Phase 1 and be instructed to completely substitute the product
      for their UBMC for one week. Participants will complete ecological momentary assessments
      (EMA) during this period to more accurately assess degree of substitution and perceived
      effects in real time. In Phase 3, participants will complete a final in-lab visit to assess
      the substitutability of their preferred product, under simulated ban conditions using a
      progressive ratio task. In all phases, multiple domains of abuse liability will be assessed,
      including product administration (in-lab puff topography and EMA self-report measures),
      product liking and craving and withdrawal suppression (in-lab and EMA self-report), and a
      hypothetical purchase task to simulate demand.
    

Intervention name(s): Menthol cigarettes substitutes; Usual brand menthol cigarettes and substitutes; Menthol cigarettes substitutes and menthol cigarettes
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.; In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week.; In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task.
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Menthol cigarettes