Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
NCT07564648 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-05-04
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Yoo Jin Cho, PhD, MPH · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2029-09-30
- Completion
- 2029-09-30
Countries
- United States
Study Locations
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