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NOT YET RECRUITING
NCT07564648
NA

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

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-06-01

Completion Date

2029-09-30

Last Updated

2026-05-04

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

Progressive Ratio Task

A concurrent choice task administered at the final laboratory visit.

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States