NCT07564648|RecruitingDMC
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Sponsor study identifier
Secondary identifiers
NIH
REGISTRY · CTRP (Clinical Trial Reporting Program)
interventional
48
1 country
1
Study Start
August 18, 2026
Actual (reported)Primary Completion
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2026
Actual (reported)May 4, 2026
Actual (reported)August 18, 2026
Actual (reported)September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Yoo Jin Cho, PhD, MPH
Ohio State University Comprehensive Cancer Center
The Ohio State University Comprehensive Cancer Center
CONTACT
First Submitted
April 27, 2026
First Posted
May 4, 2026
Study Start
August 18, 2026
Actual (reported)Modulating Neural Mechanisms of Reward Processing in Tobacco Users
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.
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.
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.
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.
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.
A concurrent choice task administered at the final laboratory visit.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 14, 2026
Record last verified: 2026-10
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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