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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA228110 | U.S. NIH Grant/Contract | View source |
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End of grant
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial tests the effect of tobacco flavor and liquid composition on the way a person puffs on a vape (topography). In general, tobacco products are designed with sensory factors in mind, such as flavor, to increase the appeal. Flavors and the composition of nicotine, either made in a lab (synthetic) or from tobacco, may create positive sensory effects, such as look, feel and taste, and influence smoking behavior and willingness to try different types of cigarettes. Understanding how nicotine vaping products are used is important in assessing individual and population level health risks. Vape flavors and synthetic nicotine may be related to harmful effects on health from vaping and may impact the appeal, risk beliefs and vaping topography.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVE:
OUTLINE:
The order of directed and ad libitum bouts are randomized within participants at each session.
SESSION 1: Participants puff their own brand liquid on study.
SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.
SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.
Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaping - | Experimental | Description The order of directed and ad libitum bouts are randomized within participants at each session. SESSION 1: Participants puff their own brand liquid on study. SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaping | Other | Undergo vape puffing regimen |
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| Measure | Description | Time Frame |
|---|---|---|
| Puff Topography: Puff Count | Measure of vaping topography counting total number of puffs. | Single Session, Approximately 2 hours in duration |
| Puff Topography: Puff Duration (in Seconds) | Measure of vaping topography counting duration of puffs in seconds. | Single Session, Approximately 2 hours in duration |
| Puff Topography: Inter Puff Interval (IPI) | Measure of vaping topography counting the interval between puffs in seconds. | Single Session, Approximately 2 hours in duration |
| Puff Topography: Puff Volume | Measure of vaping topography measuring the volume per puff in ml. | Single Session, Approximately 2 hours in duration |
| Puff Topography: Flow Rate | Measure of vaping topography measuring the rate of flow per puff in milliliters per second. | Single Session, Approximately 2 hours in duration |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Questionnaires of Product Evaluation | Will be assessed by Duke Sensory Scale | Single Session, Approximately 2 hours in duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard O'Connor | Roswell Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Population | SESSION 1: Participants puff their own brand liquid on study. SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session 1: Own Brand Topography |
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| Sessions 2-5: Tobacco Flavors |
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| Sessions 6-7: Nicotine Formulations |
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Prospective participants completed 6-n-propylthiouracil (PROP), and sodium benzoate tasting, commonly used indicators linked to individual differences in sensory perception, using manufactured, pre-calibrated calibrated strips.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaping - | Description The order of directed and ad libitum bouts are randomized within participants at each session. SESSION 1: Participants puff their own brand liquid on study. SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study. Vaping: Undergo vape puffing regimen Biospecimen Collection: Undergo collection of saliva samples and oral cell samples Questionnaire Administration: Administer Quesitonnaire |
| 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 |
| 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 | Puff Topography: Puff Count | Measure of vaping topography counting total number of puffs. | Posted | Mean | Standard Error | Number of Puffs | Single Session, Approximately 2 hours in duration |
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1 year
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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 | Session 1: Own Brand Topography Ad Lib | SESSION 1: Participants puff their own brand liquid on study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Fix | Roswell Park Comprehensive Cancer Center | 716-845-2300 | Brian.Fix@roswellpark.org |
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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 | Jan 3, 2024 | Oct 29, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2024 | Mar 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Biospecimen Collection | Procedure | Undergo collection of saliva samples and oral cell samples |
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| Questionnaire Administration | Other | Administer Quesitonnaire |
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| RY4 Liquid Ad Lib |
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| RY4 Liquid Directed |
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| Red Oak Liquid Ad Lib |
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| Red Oak Liquid Directed |
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| Unflavored Liquid Ad Lib |
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| Unflavored Liquid Directed |
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| COMPLETED |
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| NOT COMPLETED |
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| Tobacco Derived Liquid Ad Lib |
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| Tobacco Derived Liquid Directed |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG003 | Sessions 2-5: Cowboy Vaping Liquid Puff Count Directed | Mean directed puff count: Cowboy vaping liquid |
| OG004 | Sessions 2-5: RY4 Double Vaping Liquid Puff Count Ad Lib | Mean ad lib puff count: RY4 Double Vaping Liquid |
| OG005 | Sessions 2-5: RY4 Double Vaping Liquid Puff Count Directed | Mean directed puff count: RY4 Double vaping liquid |
| OG006 | Sessions 2-5: Unflavored Vaping Liquid Puff Count Ad Lib | Mean ad lib puff count: Unflavored vaping liquid |
| OG007 | Sessions 2-5: Unflavored Vaping Liquid Puff Count Directed | Mean directed puff count: Unflavored vaping liquid |
| OG008 | Sessions 2-5: Red Oak Vaping Liquid Puff Count Ad Lib | Mean ad lib puff count: Red Oak vaping liquid |
| OG009 | Sessions 2-5: Red Oak Vaping Liquid Puff Count Directed | Mean directed puff count: Red Oak vaping liquid |
| OG010 | Session 6-7: Synthetic Nicotine Liquid Puff Count Ad Lib | Mean ad lib puff count: Synthetic vaping liquid |
| OG011 | Session 6-7: Synthetic Nicotine Liquid Puff Count Directed | Mean directed ad lib puff count: Synthetic vaping liquid |
| OG012 | Session 6-7: Tobacco Derived Liquid Puff Count Ad Lib | Mean ad lib puff count: Tobacco Derived vaping liquid |
| OG013 | Session 6-7: Tobacco Derived Liquid Puff Count Directed | Mean directed puff count: Tobacco Derived vaping liquid |
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| Primary | Puff Topography: Puff Duration (in Seconds) | Measure of vaping topography counting duration of puffs in seconds. | Posted | Mean | Standard Error | Mean Duration of Puffs (in seconds) | Single Session, Approximately 2 hours in duration |
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| Primary | Puff Topography: Inter Puff Interval (IPI) | Measure of vaping topography counting the interval between puffs in seconds. | Posted | Mean | Standard Error | Mean number of seconds between puffs | Single Session, Approximately 2 hours in duration |
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|
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| Primary | Puff Topography: Puff Volume | Measure of vaping topography measuring the volume per puff in ml. | Posted | Mean | Standard Error | Volume per puff (ml) | Single Session, Approximately 2 hours in duration |
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| Primary | Puff Topography: Flow Rate | Measure of vaping topography measuring the rate of flow per puff in milliliters per second. | Posted | Mean | Standard Error | ml per second | Single Session, Approximately 2 hours in duration |
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| Secondary | Subjective Questionnaires of Product Evaluation | Will be assessed by Duke Sensory Scale | Mean sensory and subjective effects scores by bout type and flavor condition, Sub-Study A. | Posted | Mean | Standard Error | units on a scale | Single Session, Approximately 2 hours in duration |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Session 1: Own Brand Topography Directed | SESSION 1: Participants puff their own brand liquid on study. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Sessions 2-5: Cowboy Liquid Topography Ad Lib | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | Sessions 2-5: Cowboy Liquid Vaping Liquid Directed | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG004 | Sessions 2-5: RY4 Vaping Liquid Topography Ad Lib | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG005 | Sessions 2-5: RY4 Vaping Liquid Topography Directed | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG006 | Sessions 2-5: Red Oak Vaping Liquid Topography Ad Lib | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG007 | Sessions 2-5: Red Oak Vaping Liquid Topography Directed | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG008 | Sessions 2-5: Unflavored Vaping Liquid Topography Ad Lib | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG009 | Unflavored Vaping Liquid Vaping Topography Directed | SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG010 | Sessions 6-7: Synthetic Nicotine Vaping Liquid Topography Ad Lib | SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG011 | Sessions 6-7: Synthetic Vaping Liquid Topography Directed | SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG012 | Sessions 6-7: Tobacco Derived Vaping Liquid Topography Ad Lib | SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG013 | Sessions 6-7: Tobacco Derived Vaping Liquid Topography Directed | SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. | 0 | 17 | 0 | 17 | 0 | 17 |
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| Pleasantness (-100 "less pleasant" - +100 "more pleasant") |
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| Tingling Sensation (0 "less tingling sensation" - 100 "more tingling sensation") |
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| Product Evaluation Score: Satisfaction (1 "not at all" - 7 "extremely") |
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| Product Evaluaton Sore: Relief (1 "not at all" - 7 "extremely") |
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