RECRUITING Not applicable ClinicalTrials.gov

Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability

Sponsor: Ohio State University Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT07564648

Registry updated: 2026-10-14

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Description

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.

Interventions

Biospecimen Collection (Behavioral)
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.
Questionnaire Administration (Behavioral)
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.
Cigarette Purchase Task (Behavioral)
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.
Cross-Price Elasticity Task (Behavioral)
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.
Daily Diary Surveys (Behavioral)
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.
Progressive Ratio Task (Behavioral)
A concurrent choice task administered at the final laboratory visit.

Eligibility criteria

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 to read, speak, and understand English Exclusion Criteria: * Current diagnosis of any significant lung diseases (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis) * History of a cardiac event or episode of cardiac distress (e.g., heart attack, hospitalization for chest pain) within the past 3 months * Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding * Self-reported use of any non-cigarette nicotine or tobacco product (e.g., e-cigarettes, cigars, oral nicotine products) or cannabis on more than 10 days in the past 30 days * Self-reported current participation in a smoking cessation program or intention to quit smoking in the next 3 months * Self-reported difficulty with blood draws

Conditions

Cigarette Addiction Tobacco Use Disorder

Locations

Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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