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

N/ANot Yet RecruitingNCT07564648

Ohio State University Comprehensive Cancer Center48 enrolled

Overview

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.

Participants complete a three-phase protocol over approximately three weeks, comprising five in-person laboratory visits and two one-week daily-diary periods. In Phase 1, participants attend a 3-hour baseline laboratory visit after a 12-hour abstinence from nicotine, tobacco, and smoked cannabis. They smoke one usual brand menthol cigarette (UBMC) in a standardized session (10 puffs over 5 minutes) while puff topography is recorded. Serial 3 mL blood samples are collected at -5, +5, +15, +30, and +60 minutes relative to smoking initiation. Subjective effects (e.g., product appeal, sensory perception, craving) are assessed before and after smoking, followed by the Cigarette Purchase Task (CPT). Participants then complete brief surveys three times daily for one week to capture product use and subjective effects in the natural environment. In Phase 2, participants return for three additional laboratory visits, each separated by at least 48 hours, and smoke one of three blinded study products in a randomized order; study coordinators remain blinded. Each visit follows the Phase 1 procedures (standardized smoking session, topography, serial blood sampling, and subjective ratings). After smoking, participants complete the CPT and the Cross-Price Elasticity Task (CPET), in which the price of UBMC increases while the study product remains fixed, characterizing substitutability. In Phase 3, participants identify their preferred study product and receive a one-week supply, with instructions to use it exclusively in place of their UBMC. They continue the three-times-daily survey schedule throughout the week. The phase concludes with a final 2-hour laboratory visit including a remaining-cigarette count and the Progressive Ratio Task (PRT), providing a measure of the relative reinforcing value of the preferred study product vs. UBMC.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Biospecimen CollectionBEHAVIORAL

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 AdministrationBEHAVIORAL

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 TaskBEHAVIORAL

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 TaskBEHAVIORAL

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 SurveysBEHAVIORAL

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 TaskBEHAVIORAL

A concurrent choice task administered at the final laboratory visit.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Plasma nicotine (Cmax)

Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.

Time frame: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks

Secondary Outcomes

Appeal ratings (Labeled Hedonic Scale)

The Labeled Hedonic Scale (LHS) is a self-reported measure of appeal. Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking.

Time frame: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks

Puff topography

Puffing topography will be summarized with total puff count, average puff duration, average inter-puff interval, average puff volume, total puff volume, average flow rate, and peak flow rate.

Time frame: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks

Sensory effects (general Labeled Magnitude Scale)

The general Labeled Magnitude Scale (gLMS) is a 5-item self-report measure of sensory effects. Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.

Time frame: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks

Nicotine craving and withdrawal (Questionnaire of smoking urges)

Craving relief will be assessed using Questionnaire of Smoking Urges (QSU). The QSU is made up of 10 statements about the respondent's feelings and thoughts about desire to smoke cigarettes as they are completing the questionnaire. The scoring comprises of two factors, each the sum of 5 items. The scores for each factor range from 5-35, and the total score (the sum of all 10 items) ranges from 10-70. For each factor and for the total score, higher scores indicate more severe urges.

Time frame: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks

Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)

Withdrawal will be assessed using Minnesota Nicotine Withdrawal Scale (MNWS). Items are rated on a 5-point scale from 0 (none) to 4 (severe). MNWS is the sum of 8 items with scores ranging from 0 to 32 with higher scores indicating more severe overall withdrawal.

Time frame: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks

Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)

MNWS-Craving will be calculated which uses a single item from the MNWS that is scored from 0-4 with higher scores indicating greater craving.

Time frame: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks

Breakpoint

Breakpoint will be defined as the first price at which cigarette consumption is zero during the Cigarette Purchase Task (CPT).