Impact of Electronic Cigarette Temperature and Solvent on Biomarkers
10 сентября 2026 г. обновлено: Zachary Bitzer, Milton S. Hershey Medical Center
Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure
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.
Обзор исследования
Статус
Еще не набирают
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
50
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Kenneth Houser, MS
- Номер телефона: 717-531-5473
- Электронная почта: khouser@pennstatehealth.psu.edu
Учебное резервное копирование контактов
- Имя: Zachary Btizer, Ph. D.
- Номер телефона: 717-531-4387
- Электронная почта: zbitzer@pennstatehealth.psu.edu
Места учебы
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-
Pennsylvania
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Hershey, Pennsylvania, Соединенные Штаты, 17033
- Penn State College of Medicine
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Контакт:
- Kenneth Houser, MS
- Номер телефона: 717-531-5473
- Электронная почта: khouser@pennstatehealth.psu.edu
-
Главный следователь:
- Zachary Bitzer, Ph.D.
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- 21 years of age or older
- Normal pulmonary and cardiovascular function with no history of COPD or cardiovascular disease (excluding hypertension)
- Current exclusive use of a sub-ohm/mod or pod EC devices (≥ 1mL e-liquid/per day, ≥6 mg/ml nicotine concentration, EC for ≥ 1 year)
- No plan on quitting nicotine use over the course of the study
- All other forms of nicotine must be used <5 days out of the past 28 days.
- Able to read and write in English
- Have access to email and a smartphone/computer that has reliable internet connection
Exclusion Criteria:
- Women who are pregnant and/or nursing or trying to become pregnant
- Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
- Respiratory diseases (e.g., exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data
- Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
- Have immediate family or household members currently participating in this trial
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Нерандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
|
Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
|
|
Экспериментальный: Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
|
Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
|
|
Экспериментальный: High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
|
Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
|
|
Экспериментальный: Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
|
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
8-isoprostane in Exhaled Breath Condensate
Временное ограничение: Baseline prior to study product use in Phase 1
|
8-isoprostane levels will be analyzed via LC-MS
|
Baseline prior to study product use in Phase 1
|
|
8-isoprostane in Exhaled Breath Condensate
Временное ограничение: 5 minutes after directed study product use in Phase 1
|
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
Временное ограничение: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
|
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
Временное ограничение: 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
|
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
Временное ограничение: Baseline prior to study product use in Phase 1
|
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
Временное ограничение: 5 minutes after directed study product use in Phase 1
|
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
Временное ограничение: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
|
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
|
|
8-OHdG DNA Adducts in Buccal Cells
Временное ограничение: 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
|
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
Временное ограничение: Baseline prior to study product use in Phase 1
|
Nicotine levels will analyzed via LC-MS
|
Baseline prior to study product use in Phase 1
|
|
Total nicotine in Blood Samples
Временное ограничение: 5 minute after directed study product use in Phase 1
|
Nicotine level will be analyzed via LC-MS
|
5 minute after directed study product use in Phase 1
|
|
Total nicotine in Blood Samples
Временное ограничение: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
|
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
Временное ограничение: 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
|
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
E-cigarette Puffing Behavior - Duration of Puffs
Временное ограничение: 5 minutes of directed study product laboratory use in Phase 1
|
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
Временное ограничение: 5 minutes of directed study product laboratory 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
Временное ограничение: 5 minutes of directed study product laboratory use in Phase 1.
|
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
Временное ограничение: 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
|
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
Временное ограничение: 5 minutes of directed study product laboratory use in Phase 1
|
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
Временное ограничение: 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
|
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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Zachary Bitzer, Ph.D., Penn State Hershey College of Medicine
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 октября 2026 г.
Первичное завершение (Оцененный)
1 августа 2028 г.
Завершение исследования (Оцененный)
1 декабря 2028 г.
Даты регистрации исследования
Первый отправленный
13 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
24 мая 2026 г.
Первый опубликованный (Действительный)
29 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY00028240
- U54DA058271 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .