Impact of Electronic Cigarette Temperature and Solvent on Biomarkers
2026年9月10日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Kenneth Houser, MS
- 電話番号：717-531-5473
- メール：khouser@pennstatehealth.psu.edu
研究連絡先のバックアップ
- 名前：Zachary Btizer, Ph. D.
- 電話番号：717-531-4387
- メール：zbitzer@pennstatehealth.psu.edu
研究場所
-
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Penn State College of Medicine
-
コンタクト：
- Kenneth Houser, MS
- 電話番号：717-531-5473
- メール：khouser@pennstatehealth.psu.edu
-
主任研究者：
- Zachary Bitzer, Ph.D.
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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%)
|
|
実験的：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%)
|
|
実験的：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%)
|
|
実験的：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)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
8-isoprostane in Exhaled Breath Condensate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Total nicotine in Blood Samples
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
E-cigarette Puffing Behavior - Duration of Puffs
時間枠：5 minutes of directed study product laboratory use in Phase 1
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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
|
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E-cigarette Puffing Behavior - Duration of Puffs
時間枠：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
時間枠：5 minutes of directed study product laboratory use in Phase 1.
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Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage.
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5 minutes of directed study product laboratory use in Phase 1.
|
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E-cigarette Puffing Behavior - Number of Puffs
時間枠：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
|
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E-cigarette Puffing Behavior - Interpuff Interval
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Zachary Bitzer, Ph.D.、Penn State Hershey College of Medicine
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月15日
一次修了 (推定)
2028年8月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年5月24日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月10日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。