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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA228110 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Rochester | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ENDS users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use Own Brand of Flavored Product | Experimental | Participants will use their current flavor of e cigarettes for 90 days |
|
| Use Provided Tobacco Flavor | Experimental | Participants will use a new assigned flavor for 90 days |
|
| Vaping Abstinence - use "Tobacco Free" Nicotine Pouches | Active Comparator | Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette Flavor | Other | Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA | Oxidative stress and inflammation in plasma using ELISA. | Up to around 90 days. |
| Respiratory Tract Inflammation Activity | Exhaled Nitric Oxide (FeNo)l be measured in participants' breath using a FDA cleared monitor NIOX VERO (Aerocrine) according to ATS guidelines. FeNO has been used to monitor airway inflammation to account for persistent and/or high allergen exposure as a factor associated with higher levels of FeNO | Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Recent Flavored Product Use | Assessed using the PhenX Toolkit which tracks tobacco use and asks subjects to retrospectively estimate product use. Amount of recent flavored product use were assessed throughout the entire study and estimates per month. The average (with standard deviation) amount of volume (mL) of e-liquid purchased by participants throughout the entire study were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maciej Goniewicz, PhD | Roswell Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14206 | United States |
There were 334 subjects responded to advertisement. Among them, 71 were deemed ineligble, and 100 were eligible but not interested, resulted in 163 protocol enrollment.
Recruitment started at June 12 2022, and completed at October 03 2024. Recruitments were performed by Roswell Park Cancer Institute, an comprehensive cancer center located at Buffalo NY, in collaboration of University of Rochester, National Institutes of Health (NIH) and National Cancer Institute (NCI).
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| ID | Title | Description |
|---|---|---|
| FG000 | Use Own Brand of Flavored Product | Participants will use their current flavor of e cigarettes for 90 days |
| FG001 | Use Provided Tobacco Flavor | Participants will use a new assigned flavor for 90 days |
| FG002 | Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches | Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Use Own Brand of Flavored Product | Participants will use their current flavor of e cigarettes for 90 days |
| BG001 | Use Provided Tobacco Flavor | Participants will use a new assigned flavor for 90 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA | Oxidative stress and inflammation in plasma using ELISA. | A quantitative measure of expression (units:pg/mg) will be produced on Visit 1-beginning of the trial and Visit 4-after 3 months ± 14 days. | Posted | Median | Inter-Quartile Range | pg/mL | Up to around 90 days. |
|
Up to 90 days
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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 | Use Own Brand of Flavored Product | Participants will use their current flavor of e cigarettes for 90 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katy Wang | Roswell Park Comprehensive Cancer Center | 716-845-1300 | 6269 | chong.wang@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 | Jun 3, 2022 | Jan 12, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2024 | Dec 19, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| Tobacco Free Nicotine Pouch | Other | participants will use tobacco free oral nicotine pouches |
|
| up to 90 days |
| Flavor Preference Questionnaire | Personal flavor questionnaire to determine flavor preference when using ENDS. Absolute favorite flavor of all most commonly used flavors (i.e. Alcohol， Candy， Chocolate， Clove or Spice， Fruit， Menthol or Mint， Other， Tobacco， Unflavored) are reported. | Up to 90 days |
| Frequency of Flavored Product Use | Questions from Wave 1 Adult PATH Survey to measure use and regularity of use flavored products, with the scores ranging of 0 and 100. Data is presented on the percentage of days between sessions participants reported use of product as median and inter-quartile range (IQR). A non-parametric Kruskal-Wallis test followed by Dunn's Multiple Comparisons with Benjamnini-Hochberg adjustment was also performed for each product to assess differences between study groups within a visit, and between visits within a study group. | Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days |
| BG002 | Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches | Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches. |
| BG003 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| OG002 |
| Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches |
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches. |
|
|
| Primary | Respiratory Tract Inflammation Activity | Exhaled Nitric Oxide (FeNo)l be measured in participants' breath using a FDA cleared monitor NIOX VERO (Aerocrine) according to ATS guidelines. FeNO has been used to monitor airway inflammation to account for persistent and/or high allergen exposure as a factor associated with higher levels of FeNO | Measurements are taken on Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days. | Posted | Median | Inter-Quartile Range | ppb | Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days |
|
|
|
| Secondary | Amount of Recent Flavored Product Use | Assessed using the PhenX Toolkit which tracks tobacco use and asks subjects to retrospectively estimate product use. Amount of recent flavored product use were assessed throughout the entire study and estimates per month. The average (with standard deviation) amount of volume (mL) of e-liquid purchased by participants throughout the entire study were reported. | Posted | Mean | Standard Deviation | mL | up to 90 days |
|
|
|
| Secondary | Flavor Preference Questionnaire | Personal flavor questionnaire to determine flavor preference when using ENDS. Absolute favorite flavor of all most commonly used flavors (i.e. Alcohol， Candy， Chocolate， Clove or Spice， Fruit， Menthol or Mint， Other， Tobacco， Unflavored) are reported. | Posted | Count of Participants | Participants | Up to 90 days |
|
|
|
| Secondary | Frequency of Flavored Product Use | Questions from Wave 1 Adult PATH Survey to measure use and regularity of use flavored products, with the scores ranging of 0 and 100. Data is presented on the percentage of days between sessions participants reported use of product as median and inter-quartile range (IQR). A non-parametric Kruskal-Wallis test followed by Dunn's Multiple Comparisons with Benjamnini-Hochberg adjustment was also performed for each product to assess differences between study groups within a visit, and between visits within a study group. | Four visits' data are analyzed. Measurements are taken on Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days | Posted | Median | Inter-Quartile Range | percentage of days | Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Use Provided Tobacco Flavor | Participants will use a new assigned flavor for 90 days | 0 | 41 | 0 | 41 | 0 | 41 |
| EG002 | Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches | Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches. | 0 | 43 | 0 | 43 | 0 | 43 |
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| Visit 3 |
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| Visit 4 |
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| Menthol or Mint |
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| Don't know |
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| Visit 3 |
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| Visit 4 |
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