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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA058271 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.
Subjects will be provided with a study e-cigarette and e-liquid to use during the duration of the study. They will be asked to complete various questionaries as well as provide blood, exhaled breath, exhaled breath condensate, saliva and buccal cell samples.
Their puffing behavior and biomarkers of tobacco exposure and harm will be measured as follows:
E-cigarette (EC) puffing behavior - In order to determine a measurement of toxicant dose, topography markers such as puff duration, number of puffs, and interpuff interval (IPI) will be assessed via video recorded sessions.
E-liquid consumption will be assessed by weighing the filled tanks before and after the session.
Subjective effects such as nicotine withdrawal symptoms, urge to vape, and positive/negative effects will be assessed by questionnaires during the human lab studies.
The total nicotine delivered and GSH oxidation will be calculated in blood via LC-MS. Exhaled breath condensate (EBC) samples will be analyzed by Liquid Chromatography/Mass Spectroscopy (LC/MS) and include the primary biomarker of oxidative stress (8-isoprostane) and a series of proinflammatory cytokines (IL-6 and hsCRP). Exfoliated buccal mucosal cells will be analyzed for 8-OHdG-DNA adducts by LC-MS/MS as a biomarker of oral oxidant exposure/damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Wattage/High Propylene Glycol | Experimental | High temperature and high propylene glycol concentration |
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| Low Wattage/Low Propylene Glycol | Experimental | Low temperature and low propylene glycol concentration |
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| High Wattage/Low Propylene Glycol | Experimental | High temperature and low propylene glycol concentration |
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| Low Wattage/High Propylene Glycol | Experimental | Low temperature and high propylene glycol concentration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High temperature wattage setting on electronic cigarette | Other | Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C) |
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| Measure | Description | Time Frame |
|---|---|---|
| 8-isoprostane in Exhaled Breath Condensate | 8-isoprostane levels will be analyzed via LC-MS | Baseline prior to study product use in Phase 1 |
| 8-isoprostane in Exhaled Breath Condensate | 8-isoprostane levels will be analyzed via LC-MS | 5 minutes after directed study product use in Phase 1 |
| 8-isoprostane in Exhaled Breath Condensate | 8-isoprostane levels will be analyzed via LC-MS | Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use |
| 8-isoprostane in Exhaled Breath Condensate | 8-isoprostane levels will be analyzed via LC-MS | 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use |
| 8-OHdG DNA Adducts in Buccal Cells | 8-OHdG-DNA adducts will be measured via LC-MS/MS | Baseline prior to study product use in Phase 1 |
| 8-OHdG DNA Adducts in Buccal Cells | 8-OHdG-DNA adducts will be measured via LC-MS/MS | 5 minutes after directed study product use in Phase 1 |
| 8-OHdG DNA Adducts in Buccal Cells | 8-OHdG-DNA adducts will be measured via LC-MS/MS | Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use |
| Measure | Description | Time Frame |
|---|---|---|
| E-cigarette Puffing Behavior - Duration of Puffs | E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage. | 5 minutes of directed study product laboratory use in Phase 1 |
| E-cigarette Puffing Behavior - Duration of Puffs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zachary Btizer, Ph. D. | Contact | 717-531-4387 | zbitzer@pennstatehealth.psu.edu | |
| Kenneth Houser, MS | Contact | 717-531-5473 | khouser@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zachary Bitzer, Ph.D. | Penn State Hershey College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
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| Low temperature wattage setting on electronic cigarette | Other | Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C) |
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| High concentration of Propylene Glycol | Other | Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%) |
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| Low concentration of Propylene Glycol | Other | Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%) |
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| 8-OHdG DNA Adducts in Buccal Cells | 8-OHdG-DNA adducts will be measured via LC-MS/MS | 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use |
| Total nicotine in Blood Samples | Nicotine levels will analyzed via LC-MS | Baseline prior to study product use in Phase 1 |
| Total nicotine in Blood Samples | Nicotine level will be analyzed via LC-MS | 5 minute after directed study product use in Phase 1 |
| Total nicotine in Blood Samples | Nicotine levels will be analyzed via LC-MS | Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use |
| Total nicotine in Blood Samples | Nicotine levels will be analyzed via LC-MS | 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use |
E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage. |
| 5 minutes of directed study product laboratory use in Phase 2b; visit occurs after 2 weeks of at home product use |
| E-cigarette Puffing Behavior - Number of Puffs | Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage. | 5 minutes of directed study product laboratory use in Phase 1. |
| E-cigarette Puffing Behavior - Number of Puffs | Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage. | 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use |
| E-cigarette Puffing Behavior - Interpuff Interval | E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage. | 5 minutes of directed study product laboratory use in Phase 1 |
| E-cigarette Puffing Behavior - Interpuff Interval | E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage. | 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012907 | Smoking |
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