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Набор скоро начнётся NCT07612696

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

Без фазы С лечением Oxidative Stress Tobacco Use Electronic Cigarettes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High temperature wattage setting on electronic cigarette, Low temperature wattage setting on electronic cigarette, High concentration of Propylene Glycol, Low concentration of Propylene Glycol.
Кому может быть актуально
Состояния в реестре: Oxidative Stress, Tobacco Use, Electronic Cigarettes. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure

Обзор

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.

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.

Вмешательства

  • Другое High temperature wattage setting on electronic cigarette
    Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
  • Другое Low temperature wattage setting on electronic cigarette
    Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)
  • Другое High concentration of Propylene Glycol
    Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
  • Другое Low concentration of Propylene Glycol
    Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)

Первичные конечные точки

  • 8-isoprostane in Exhaled Breath Condensate [Срок оценки: Baseline prior to study product use in Phase 1]
  • 8-isoprostane in Exhaled Breath Condensate [Срок оценки: 5 minutes after directed study product use in Phase 1]
  • 8-isoprostane in Exhaled Breath Condensate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline prior to study product use in Phase 1]
  • 8-OHdG DNA Adducts in Buccal Cells [Срок оценки: 5 minutes after directed study product use in Phase 1]
  • 8-OHdG DNA Adducts in Buccal Cells [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline prior to study product use in Phase 1]
  • Total nicotine in Blood Samples [Срок оценки: 5 minute after directed study product use in Phase 1]
Вторичные конечные точки (6)
  • E-cigarette Puffing Behavior - Duration of Puffs [Срок оценки: 5 minutes of directed study product laboratory use in Phase 1]
  • E-cigarette Puffing Behavior - Duration of Puffs [Срок оценки: 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 [Срок оценки: 5 minutes of directed study product laboratory use in Phase 1.]
  • E-cigarette Puffing Behavior - Number of Puffs [Срок оценки: 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 [Срок оценки: 5 minutes of directed study product laboratory use in Phase 1]
  • E-cigarette Puffing Behavior - Interpuff Interval [Срок оценки: 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Penn State College of Medicine — Hershey

Идентификаторы

NCT: NCT07612696 · STUDY00028240 · U54DA058271

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗