Health TrialsbyHealthPanel

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

ConditionsCigarette AddictionTobacco Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Study Cigarette AExperimental treatment 6 interventions
Group B: Study Cigarette BExperimental treatment 6 interventions
Group C: Study Cigarette CExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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