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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-10761 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Approximately 43% of adult smokers smoke menthol cigarettes. Regulatory agencies have begun a ban on menthol. In response to the ban, the tobacco industry has introduced synthetic cooling agents as a flavorless replacement to provide the same cooling effects as menthol. Information gained from this trial may help researchers determine how the addition of synthetic cooling agents changes the appeal, abuse liability potential, and respiratory toxicity profile of combustible cigarettes.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol cigarette | Active Comparator | 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. |
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| Non-menthol cigarette | Active Comparator | 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. |
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| Cigarette with synthetic cooling agents | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-menthol Cigarette Smoking | Behavioral | Smoke a non-menthol cigarette |
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| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Chemical Contents | Before participant recruitment began, chemical content analysis of 3 cigarettes of each study condition was performed. We used liquid-liquid extraction (LLE) to extract nicotine, WS-3, WS-23, and menthol from cigarette samples and quantified these analytes using gas chromatography-mass spectrometry (GC-MS). | Approximately 3 months prior to start of participant recruitment |
| Impact of Cooling Effects on Demand Via the Forced Choice Task | At each study visit, after the participant has smoked the study cigarette, the participant must choose between smoking the study cigarette again, or smoking one of their own, usual brand cigarettes. Within each arm, the proportion of participants who opt to continue smoking the study cigarette will be reported. This will measure if demand for the study cigarettes is great enough to overcome the desire for the participant's own preferred cigarettes. | After completion of study cigarette smoking session (Week 1, Week 2, Week 3) |
| Abuse Liability Via Puff Topography - Total Smoking Time | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | During study cigarette smoking session (Week 1, Week 2, Week 3) |
| Abuse Liability Via Puff Topography - Average Puff Duration | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | During study cigarette smoking session (Week 1, Week 2, Week 3) |
| Abuse Liability Via Puff Topography - Average Flow Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alayna P Tackett, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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2 participants were enrolled in the study but withdrew prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synthetic Cooling - Non-Menthol - Menthol | Participants smoke a cigarette with synthetic cooling agents on visit 1, a non-menthol cigarette on visit 2, and a menthol cigarette on visit 3 |
| FG001 | Synthetic Cooling - Menthol - Non-Menthol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2023 |
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Using a cross-over double-blinded study design, we will study the abuse liability (including sensory characteristics and appeal) of newly introduced cooling agent non-menthol cigarettes.
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Participants and data collection staff will be blinded to the order/conditions
| Menthol Cigarette Smoking |
| Behavioral |
Smoke a menthol cigarette |
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| Synthetic Cooling Agent Cigarette Smoking | Behavioral | Smoke a synthetic cooling agent cigarette |
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| Usual Brand Cigarette Smoking | Behavioral | Smoke usual brand cigarette |
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| Spirometry | Diagnostic Test | Pulmonary function test |
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| Questionnaire Administration | Other | Survey questionnaires |
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| Nasal Epithelial Lining Fluid | Diagnostic Test | Nasal strip inserted into the nare to collect nasal epithelial lining fluid. |
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Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. |
| During study cigarette smoking session (Week 1, Week 2, Week 3) |
| Abuse Liability Via Puff Topography - Average Inter-Puff Interval | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | During study cigarette smoking session (Week 1, Week 2, Week 3) |
| Abuse Liability Via Puff Topography - Average Puff Volume | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | During study cigarette smoking session (Week 1, Week 2, Week 3) |
| Cigarette Appeal | Participants will complete the Appeal and Sensory Quality questionnaire after smoking each study cigarette. This questionnaire will ask participants to rate each study cigarette for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all)-100(extremely). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc. | Post study cigarette smoking session (Week1, Week 2, Week 3) |
Participants smoke a cigarette with synthetic cooling agents on visit 1, a menthol cigarette on visit 2, and a non-menthol cigarette on visit 3 |
| FG002 | Non-Menthol - Synthetic Cooling - Menthol | Participants smoke a non-menthol cigarette on visit 1, a cigarette with synthetic cooling agents on visit 2, and a menthol cigarette on visit 3 |
| FG003 | Non-Menthol - Menthol - Synthetic Cooling | Participants smoke a non-menthol cigarette on visit 1, a menthol cigarette on visit 2, and a cigarette with synthetic cooling agents on visit 3 |
| FG004 | Menthol - Synthetic Cooling - Non-Menthol | Participants smoke a menthol cigarette on visit 1, a cigarette with synthetic cooling agents on visit 2, and a non-menthol cigarette on visit 3 |
| FG005 | Menthol - Non-Menthol - Synthetic Cooling | Participants smoke a menthol cigarette on visit 1, a non-menthol cigarette on visit 2, and a cigarette with synthetic cooling agents on visit 3 |
| COMPLETED |
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| NOT COMPLETED |
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| Visit 2 |
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| Visit 3 |
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34 participants were enrolled but 2 withdrew prior to completing baseline demographics
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Population | Full population of participants assessed at baseline. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Cigarettes Smoked per Day | Mean | Standard Deviation | cigarettes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cigarette Chemical Contents | Before participant recruitment began, chemical content analysis of 3 cigarettes of each study condition was performed. We used liquid-liquid extraction (LLE) to extract nicotine, WS-3, WS-23, and menthol from cigarette samples and quantified these analytes using gas chromatography-mass spectrometry (GC-MS). | Only the study products were analysed for this aim, no participant data was included | Posted | Mean | Standard Deviation | mg/g of tobacco rod | Approximately 3 months prior to start of participant recruitment | Cigarette rod | Cigarette rod |
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| Primary | Impact of Cooling Effects on Demand Via the Forced Choice Task | At each study visit, after the participant has smoked the study cigarette, the participant must choose between smoking the study cigarette again, or smoking one of their own, usual brand cigarettes. Within each arm, the proportion of participants who opt to continue smoking the study cigarette will be reported. This will measure if demand for the study cigarettes is great enough to overcome the desire for the participant's own preferred cigarettes. | 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. 1 Participant excluded for their synthetic cooling agent study visit as their forced choice task was not recorded. | Posted | Count of Participants | Participants | After completion of study cigarette smoking session (Week 1, Week 2, Week 3) |
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| Primary | Abuse Liability Via Puff Topography - Total Smoking Time | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. 1 Participant was excluded for their cigarette with synthetic cooling agents visit as topography measures were not recorded. 1 Participant was excluded for their menthol cigarette visit as accurate topography measures were not recorded. | Posted | Mean | Standard Deviation | seconds | During study cigarette smoking session (Week 1, Week 2, Week 3) |
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| Primary | Abuse Liability Via Puff Topography - Average Puff Duration | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. 1 Participant was excluded for their cigarette with synthetic cooling agents visit as topography measures were not recorded. 1 Participant was excluded for their menthol cigarette visit as accurate topography measures were not recorded. | Posted | Mean | Standard Deviation | seconds | During study cigarette smoking session (Week 1, Week 2, Week 3) |
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| Primary | Abuse Liability Via Puff Topography - Average Flow Rate | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. 1 Participant was excluded for their cigarette with synthetic cooling agents visit as topography measures were not recorded. 1 Participant was excluded for their menthol cigarette visit as accurate topography measures were not recorded. | Posted | Mean | Standard Deviation | mL/s | During study cigarette smoking session (Week 1, Week 2, Week 3) |
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| Primary | Abuse Liability Via Puff Topography - Average Inter-Puff Interval | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. 1 Participant was excluded for their cigarette with synthetic cooling agents visit as topography measures were not recorded. 1 Participant was excluded for their menthol cigarette visit as accurate topography measures were not recorded. | Posted | Mean | Standard Deviation | seconds | During study cigarette smoking session (Week 1, Week 2, Week 3) |
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| Primary | Abuse Liability Via Puff Topography - Average Puff Volume | Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability. | 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. 1 Participant was excluded for their cigarette with synthetic cooling agents visit as topography measures were not recorded. 1 Participant was excluded for their menthol cigarette visit as accurate topography measures were not recorded. | Posted | Mean | Standard Deviation | mL | During study cigarette smoking session (Week 1, Week 2, Week 3) |
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| Primary | Cigarette Appeal | Participants will complete the Appeal and Sensory Quality questionnaire after smoking each study cigarette. This questionnaire will ask participants to rate each study cigarette for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all)-100(extremely). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc. | 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. | Posted | Mean | Standard Deviation | Score on a scale | Post study cigarette smoking session (Week1, Week 2, Week 3) |
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Up to 3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Usual Brand Cigarette | Participants who opted to smoke their usual brand cigarette during the forced choice task on at least one of the 3 study visits. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alayna Tackett | Ohio State University Comprehensive Cancer Center | 844-744-2447 | alayna.tackett@osumc.edu |
| Feb 17, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2023 | Feb 17, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D013147 | Spirometry |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| WS-3 |
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| WS-23 |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 |
| 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. |
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