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NCT07564648
Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
Conditions: Cigarette Addiction, Tobacco Use Disorder
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 48
Sponsor: Ohio State University Comprehensive Cancer Center
Location: Ohio State University Comprehensive Cancer Center Columbus Ohio
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.
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
Source: ClinicalTrials.gov (NCT07564648). StuddyBuddy aggregates publicly available trial information.