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

Conditions

• Cigarette Addiction
• Tobacco Use Disorder

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Accepted

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.

Study Details

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 Dates

Start date

Jun 22, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

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