Recruiting

Menthol & Non-MentholImpact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07564648

Conditions

Cigarette Addiction

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Questionnaire Administration

Cigarette Purchase Task

Cross-Price Elasticity Task

Daily Diary Surveys

Study Details

Brief 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.

Conditions

Cigarette Addiction

Tobacco Use Disorder

Study ID

NCT07564648

Start date

Aug 18, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Study Cigarette A

Participants smoke one Study Cigarette A during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling. Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session. Order of exposure to Study Cigarettes A, B, and C is randomized.

experimental: Study Cigarette B

Participants smoke one Study Cigarette B during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling. Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session. Order of exposure to Study Cigarettes A, B, and C is randomized.

experimental: Study Cigarette C

Participants smoke one Study Cigarette C during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling. Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session. Order of exposure to Study Cigarettes A, B, and C is randomized.

Interventions

Biospecimen 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.

Questionnaire 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.

Cigarette 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.

Cross-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.

Daily Diary Surveys

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

A concurrent choice task administered at the final laboratory visit.

Primary outcome measure

Plasma nicotine (Cmax) [ Time Frame: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Yoo Jin Cho, PhD, MPH

614-366-7048 Yoojin.cho@osumc.edu

Principal Investigator:

Yoo Jin Cho, PhD, MPH

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

Cigarette Addiction
Cigarette

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.