Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- BehavioralBiospecimen Collection
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.
- BehavioralQuestionnaire Administration
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.
- BehavioralCigarette Purchase Task
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.
- BehavioralCross-Price Elasticity Task
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.
- BehavioralDaily Diary Surveys
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio