Ohio State University Comprehensive Cancer Center
This randomized, double-blind, crossover human laboratory study compares the abuse liability of cigarettes containing menthol and non-menthol cigarette variants, using the participant's usual brand menthol cigarette as a within-subject reference. Participants complete standardized laboratory smoking sessions, behavioral economic tasks, and a naturalistic observational period. The study examines differences in nicotine delivery, smoking behavior, and subjective effects across cigarette types in laboratory and real-world contexts.
Participants complete a three-phase protocol over approximately three weeks, comprising five in-person laboratory visits and two one-week daily-diary periods. In Phase 1, participants attend a 3-hour baseline laboratory visit after a 12-hour abstinence from nicotine, tobacco, and smoked cannabis. They smoke one usual brand menthol cigarette (UBMC) in a standardized session (10 puffs over 5 minutes) while puff topography is recorded. Serial 3 mL blood samples are collected at -5, +5, +15, +30, and +60 minutes relative to smoking initiation. Subjective effects (e.g., product appeal, sensory per…
Inclusion Criteria: * Aged 21 years or older * Currently smoke cigarettes daily (≥ 5 cigarettes/day) for at least the past 6 months, and their usual brand is menthol cigarettes * Willing to provide informed consent * Willing to abstain from all nicotine, tobacco, and smoked cannabis products for approximately 12 hours prior to each study visit * Own and regularly use a functional smartphone compatible with study procedures (e.g., completing daily assessments) * Willing to complete two weeks of daily assessments involving use of their usual brand menthol cigarettes and the study product * Able…
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session. Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session. Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
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