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Cigarette AddictionNCT07564648

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

A study testing Biospecimen Collection, Questionnaire Administration and Cigarette Purchase Task in people with Cigarette Addiction and Tobacco Use Disorder, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Cigarette Addiction, Tobacco Use Disorder
What is being tested?
Biospecimen Collection, Questionnaire Administration and Cigarette Purchase Task
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
18 Aug 2026to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting
  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Vishva Bhavsar, 614-935-2935, osumenthol-study@osumc.edu

    Yoo Jin Cho, PhD, MPH

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Biospecimen Collection, Questionnaire Administration, Cigarette Purchase Task, Cross-Price Elasticity Task, Daily Diary Surveys
Keywords
Cigarette Addiction, Cigarette
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionBehavioural

    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 AdministrationBehavioural

    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 TaskBehavioural

    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 TaskBehavioural

    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 SurveysBehavioural

    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 TaskBehavioural

    A concurrent choice task administered at the final laboratory visit.

Study groups in NCT07564648
Study groupRoleWhat they receive
Study Cigarette AExperimentalParticipants 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.
Receives: 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 BExperimentalParticipants 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.
Receives: 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 CExperimentalParticipants 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.
Receives: Behavioral: Biospecimen Collection; Behavioral: Questionnaire Administration; Behavioral: Cigarette Purchase Task; Behavioral: Cross-Price Elasticity Task; Behavioral: Daily Diary Surveys; Behavioral: Progressive Ratio Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma nicotine (Cmax)

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

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

Secondary outcomes (15)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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.

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

  6. 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.

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

  7. Breakpoint

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

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  8. Demand intensity (Q0)

    Demand intensity will be defined as cigarette consumption at the lowest cigarette price of $0 during the Cigarette Purchase Task (CPT).

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  9. Maximum financial expenditure on cigarettes (Omax)

    Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the maximum financial expenditure.

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  10. Price at which expenditure is maximized (Pmax)

    Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the price at which expenditure is maximized.

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  11. Demand elasticity (alpha)

    Sensitivity of cigarette consumption to increase in price assessed using the Cigarette Purchase Task (CPT).

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  12. Cross-over price

    The price at which two options valued approximately equally will be calculated from the Cross Price Elasticity Task (CPET).

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  13. Progressive ratio task

    The proportion of puffs allocated to the study products versus usual brand menthol cigarettes (UBMC) will be measured with the Progressive Ratio Task (PRT).

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  14. Preferred product selection

    Count of participants selecting each of the 3 study products after completion of the 3 Phase 2 smoking sessions.

    Measured: Post Phase 2 smoking sessions, assessed up to 3 weeks

  15. Product substitution

    Substitution assessed via use behavior during Phase 3 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time.

    Measured: 1 week Phase 3 substitution period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start18 Aug 2026
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564648
Sponsor's protocol ID
OSU-25014
Other IDs
K01DA061444, NCI-2026-01493
Status last verified
Oct 2026
First submitted
27 Apr 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be archived through the National Addiction \& HIV Data Archive Program (NAHDAP) at the Inter-university Consortium for Political and Social Research (ICPSR). Access requires a Restricted Data Use Agreement.

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Questionnaire Administration and Cigarette Purchase Task in people with Cigarette Addiction and Tobacco Use Disorder, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma nicotine (Cmax) (time frame: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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