Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use
NCT ID: NCT06230159
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2023-11-28
2024-06-12
Brief Summary
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Detailed Description
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I. Assess the content of synthetic cooling agents in newly introduced cooling agent non-menthol, menthol, and traditional non-menthol cigarettes.
II. Assess the subjective effects and abuse liability of cooling agent non-menthol cigarettes.
EXPLORATORY OBJECTIVE:
I. Examine acute changes to pulmonary health associated with cooling agent cigarette use.
OUTLINE: Participants are randomized to use 1 of 3 cigarette conditions at 3 different study visits.
Participants participate in ad libitum smoking sessions with either a non-menthol control, menthol, or synthetic cooling agent cigarette condition once weekly (QW) over 3 weeks on study. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the study cigarette condition at the end of each study visit. Participants also undergo nasal swab collection over 5-10 minutes and spirometry and airwave oscillometry testing over 5-10 minutes pre- and post-smoking session at each study visit.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Menthol cigarette
Participants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit.
Menthol Cigarette Smoking
Smoke a menthol cigarette
Usual Brand Cigarette Smoking
Smoke usual brand cigarette
Spirometry
Pulmonary function test
Questionnaire Administration
Survey questionnaires
Nasal Epithelial Lining Fluid
Nasal strip inserted into the nare to collect nasal epithelial lining fluid.
Non-menthol cigarette
Participants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit.
Non-menthol Cigarette Smoking
Smoke a non-menthol cigarette
Usual Brand Cigarette Smoking
Smoke usual brand cigarette
Spirometry
Pulmonary function test
Questionnaire Administration
Survey questionnaires
Nasal Epithelial Lining Fluid
Nasal strip inserted into the nare to collect nasal epithelial lining fluid.
Cigarette with synthetic cooling agents
Participants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit.
Synthetic Cooling Agent Cigarette Smoking
Smoke a synthetic cooling agent cigarette
Usual Brand Cigarette Smoking
Smoke usual brand cigarette
Spirometry
Pulmonary function test
Questionnaire Administration
Survey questionnaires
Nasal Epithelial Lining Fluid
Nasal strip inserted into the nare to collect nasal epithelial lining fluid.
Interventions
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Non-menthol Cigarette Smoking
Smoke a non-menthol cigarette
Menthol Cigarette Smoking
Smoke a menthol cigarette
Synthetic Cooling Agent Cigarette Smoking
Smoke a synthetic cooling agent cigarette
Usual Brand Cigarette Smoking
Smoke usual brand cigarette
Spirometry
Pulmonary function test
Questionnaire Administration
Survey questionnaires
Nasal Epithelial Lining Fluid
Nasal strip inserted into the nare to collect nasal epithelial lining fluid.
Eligibility Criteria
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Inclusion Criteria
* Established cigarette user
* Willing to provide informed consent and abstain from using tobacco products 12 hours prior to the three lab sessions
* Read and speak English
Exclusion Criteria
* Self-reported unstable or significant psychiatric conditions
* History of cardiac event or distress within the past 3 months
* Are currently pregnant, planning to become pregnant, or breastfeeding
* Currently attempting to quit using combustible tobacco products
* Have suffered from any serious lung disease or infection in the past 30 days
21 Years
29 Years
ALL
Yes
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Alayna Tackett
Principal Investigator
Principal Investigators
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Alayna P Tackett, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2023-10761
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-23208
Identifier Type: -
Identifier Source: org_study_id
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