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

NCT07564648 | Not Yet Recruiting DMC

• 3 other identifiers: OSU-25014K01DA061444NCI-2026-01493
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cigarette Addiction; Cigarette

Outcome Measures

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.

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

Secondary Outcomes (15)

• Appeal ratings (Labeled Hedonic Scale)

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

• Puff topography

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

• Sensory effects (general Labeled Magnitude Scale)

  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)

  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)

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

Study Arms (3)

Study Cigarette A

EXPERIMENTAL

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.

Behavioral: Biospecimen Collection; Behavioral: Questionnaire Administration; Behavioral: Cigarette Purchase Task; Behavioral: Cross-Price Elasticity Task; Behavioral: Daily Diary Surveys; Behavioral: Progressive Ratio Task

Study Cigarette B

EXPERIMENTAL

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.

Behavioral: Biospecimen Collection; Behavioral: Questionnaire Administration; Behavioral: Cigarette Purchase Task; Behavioral: Cross-Price Elasticity Task; Behavioral: Daily Diary Surveys; Behavioral: Progressive Ratio Task

Study Cigarette C

EXPERIMENTAL

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.

Behavioral: Biospecimen Collection; Behavioral: Questionnaire Administration; Behavioral: Cigarette Purchase Task; Behavioral: Cross-Price Elasticity Task; Behavioral: Daily Diary Surveys; Behavioral: Progressive Ratio Task

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.

Study Cigarette A; Study Cigarette B; Study Cigarette C

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.

Study Cigarette A; Study Cigarette B; Study Cigarette C

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.

Study Cigarette A; Study Cigarette B; Study Cigarette C

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.

Study Cigarette A; Study Cigarette B; Study Cigarette C

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.

Study Cigarette A; Study Cigarette B; Study Cigarette C

Progressive Ratio Task BEHAVIORAL

A concurrent choice task administered at the final laboratory visit.

Study Cigarette A; Study Cigarette B; Study Cigarette C

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Yoo Jin Cho, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study cigarettes are provided in identical, unmarked packaging. Participants and study coordinators involved in data collection are blinded to product assignment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants complete three blinded laboratory sessions in randomized order in which they smoke each of three study cigarettes in Phase 2, with sessions separated by at least 48 hours.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)