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Puff Topography and Sensory Effects Across IQOS Device Generations

2026年7月29日 更新者：American University of Beirut Medical Center

Puff Topography and Sensory Effects Across IQOS Device Generations: A Randomized Crossover Study

The goal of this clinical trial is to learn how people use two generations of IQOS heated tobacco devices and how each device affects their smoking behavior and sensory experience.

The main questions it aims to answer are:

  • Do participants puff differently when using the newer IQOS Iluma i compared to the older IQOS 2.4?
  • Does the flavor of the tobacco stick (preferred flavor vs. standard tobacco flavor) affect puffing behavior or sensory experience?
  • What are the differences in throat hit, mouthfeel, and satisfaction between the two devices?

Participants will:

  • Attend 2 laboratory visits at the American University of Beirut
  • Use both the IQOS Iluma i and IQOS 2.4 devices during each visit
  • Have their puffing behavior recorded automatically during device use
  • Provide a breath sample before and after each use session
  • Complete short questionnaires about how each device felt and their urge to smoke

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Heated tobacco products (HTPs) such as IQOS have evolved across generations, with newer models using induction-based heating rather than a ceramic blade. Nicotine yields have declined across generations, raising the possibility that sensory characteristics have been modified to maintain product appeal. Current emissions assessments rely on standardized machine-puffing regimens derived from cigarette testing, which may not reflect real-world IQOS user behavior. This study will characterize puff topography (volume, duration, flow rate, inter-puff interval, number of puffs) in 50 exclusive IQOS users during ad-libitum use of the IQOS Iluma i and IQOS 2.4 under preferred and standardized (Amber) flavor conditions. A randomized crossover design with two visits will be used, with device order within each visit randomized using a Williams design. Secondary outcomes include chemosensory ratings (mouthfeel, ease of draw, throat hit), and subjective effects (satisfaction, pleasantness, taste, urges). Data will inform device-specific puffing regimens for use in future emissions assessments.

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：Soha Talih, PhD
  • 電話番号：3627 +961-1-350000
  • メール：st38@aub.edu.lb

研究連絡先のバックアップ

  • 名前：Mario El Hourani, PhD
  • 電話番号：+96170715263
  • メール：me217@aub.edu.lb

研究場所

  • レバノン
      • Beirut、レバノン
        • 募集
        • Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
    • Beirut
      • Beirut、Beirut、レバノン、1107 2020
        • 募集
        • Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
        • コンタクト：
          • Dr. Soha Talih, PHD
          • 電話番号：3627 +9611350000
          • メール：st38@aub.edu.lb

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

はい

説明

Inclusion Criteria:

  • Current IQOS user (at least 3 days per week in the past 30 days)
  • Age 18 to 65 years
  • Generally healthy
  • Willing to provide informed written consent
  • Willing to attend all laboratory visits
  • Willing to abstain from all nicotine and tobacco products for at least 12 hours before each visit

Exclusion Criteria:

  • Use of any tobacco products other than IQOS in the past 30 days
  • Chronic cardiovascular conditions, seizures, or abnormal blood pressure
  • Current psychiatric disorder requiring active treatment, including major depressive disorder
  • Regular use of prescription medications that may influence cardiovascular function, respiratory function, or nicotine metabolism (excluding vitamins or birth control)
  • Use of cocaine, opioids, benzodiazepines, or methamphetamines in the past month
  • Marijuana use on more than 15 days per month
  • Current pregnancy or breastfeeding
  • Plans to quit nicotine or tobacco products within the next 30 days

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：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：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：IQOS Iluma i (Induction Heating)
Participants use the IQOS Iluma i device with TEREA tobacco sticks under two flavor conditions (preferred flavor and standardized Amber flavor) across study visits. The IQOS Iluma i uses induction-based heating technology.
デバイス：IQOS Iluma i with TEREA Tobacco Sticks
The IQOS Iluma i is an induction-heated tobacco device used with TEREA STICKS. Participants use the device ad libitum during two smoking bouts (preferred flavor and Amber flavor conditions) across two study visits. Puff topography is recorded continuously during use.
アクティブコンパレータ：IQOS 2.4 (Blade Heating)
Participants use the IQOS 2.4 device with HEETS tobacco sticks under two flavor conditions (preferred flavor and standardized Amber flavor) across study visits. The IQOS 2.4 uses ceramic blade heating technology.
デバイス：IQOS 2.4 with HEETS Tobacco Sticks
The IQOS 2.4 is a ceramic blade-heated tobacco device used with HEETS tobacco sticks. Participants use the device ad libitum during two smoking bouts (preferred flavor and Amber flavor conditions) across two study visits. Puff topography is recorded continuously during use.

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
Chemosensory Effects - Mouthful
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (1) Mouthful - amount of aerosol filling the mouth, rated on a 1-5 visual analog scale (1 = barely any smoke to 5 = a lot of smoke); higher scores indicate greater mouthful sensation.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects - Ease of draw
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (2) Ease of draw - effort required to draw a puff, rated on a 1-5 visual analog scale (1 = easy to 5 = hard); higher scores indicate greater effort required.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects - Throat hit
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (3) Throat hit - intensity of throat sensation, rated on a 0-100 General Labeled Magnitude Scale (0 = barely detectable to 100 = strongest imaginable); higher scores indicate greater throat hit intensity.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean Puff Duration
時間枠：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean duration (seconds) of each puff recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Number of Puffs Per Stick
時間枠：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Total number of puffs taken per tobacco stick during each ad-libitum smoking bout, recorded using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean Inter-Puff Interval
時間枠：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean time (seconds) between the end of one puff and the start of the next, recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean Puff Flow Rate
時間枠：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean peak puff flow rate (mL/s) recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to Use IQOS - Factor 1: desire/intention
時間枠：Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to use IQOS assessed using a 10-item adaptation of the Questionnaire on Smoking Urges-Brief (QSU-Brief), rated on a 7-point scale (1 = Strongly Disagree to 7 = Strongly Agree). Higher scores indicate greater urge to use IQOS. Total score and subscale scores (Factor 1: desire/intention; Factor 2: negative reinforcement) will be reported.
Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to Use IQOS - Factor 2: negative reinforcement
時間枠：Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to use IQOS assessed using a 10-item adaptation of the Questionnaire on Smoking Urges-Brief (QSU-Brief), rated on a 7-point scale (1 = Strongly Disagree to 7 = Strongly Agree). Higher scores indicate greater urge to use IQOS. Total score and subscale scores (Factor 1: desire/intention; Factor 2: negative reinforcement) will be reported.
Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - satisfaction
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - taste
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - throat/chest sensations
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - calm
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - awake
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - irritable
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - concentration
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - hungry
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - dizziness
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - nausea
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - craving relief
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - enjoyment
時間枠：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)

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。

スポンサー

American University of Beirut Medical Center

捜査官

  • 主任研究者：Soha Talih、American University of Beirut Medical Center

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 (実際)

2026年7月27日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年12月15日

試験登録日

最初に提出

2026年7月3日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月30日

QC基準を満たした最後の更新が送信されました

2026年7月29日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BIO-2026-0012
  • AUB (その他の助成金/資金番号：American University of Beirut)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be shared. Data are stored on password-protected institutional computers at the American University of Beirut and are accessible only to authorized study personnel. Data may be made available to qualified researchers upon reasonable request to the corresponding author.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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