Puff Topography and Sensory Effects Across IQOS Device Generations
2026년 7월 29일 업데이트: 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
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
50
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Soha Talih, PhD
- 전화번호: 3627 +961-1-350000
- 이메일: st38@aub.edu.lb
연구 연락처 백업
- 이름: Mario El Hourani, PhD
- 전화번호: +96170715263
- 이메일: me217@aub.edu.lb
연구 장소
-
-
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Beirut, 레바논
- 모병
- Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
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Beirut
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Beirut, Beirut, 레바논, 1107 2020
- 모병
- Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
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연락하다:
- Dr. Soha Talih, PHD
- 전화번호: 3627 +9611350000
- 이메일: st38@aub.edu.lb
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Chemosensory Effects - Mouthful
기간: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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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.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Chemosensory Effects - Ease of draw
기간: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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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.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Chemosensory Effects - Throat hit
기간: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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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.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Mean Puff Duration
기간: 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)
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Mean duration (seconds) of each puff recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
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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)
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Number of Puffs Per Stick
기간: 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)
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Total number of puffs taken per tobacco stick during each ad-libitum smoking bout, recorded using the eTOP puff topography instrument.
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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)
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Mean Inter-Puff Interval
기간: 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)
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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.
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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)
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Mean Puff Flow Rate
기간: 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)
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Mean peak puff flow rate (mL/s) recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
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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)
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Urge to Use IQOS - Factor 1: desire/intention
기간: 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)
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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.
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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)
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Urge to Use IQOS - Factor 2: negative reinforcement
기간: 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)
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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.
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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)
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Subjective Effects of IQOS Use - satisfaction
기간: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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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.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - taste
기간: 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.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
|
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Subjective Effects of IQOS Use - throat/chest sensations
기간: 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)
|
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Subjective Effects of IQOS Use - calm
기간: 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)
|
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Subjective Effects of IQOS Use - awake
기간: 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.
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Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
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Subjective Effects of IQOS Use - irritable
기간: 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)
|
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Subjective Effects of IQOS Use - concentration
기간: 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)
|
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Subjective Effects of IQOS Use - hungry
기간: 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)
|
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Subjective Effects of IQOS Use - dizziness
기간: 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)
|
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Subjective Effects of IQOS Use - nausea
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Soha Talih, American University of Beirut Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 7월 27일
기본 완료 (추정된)
기본 완료
2027년 10월 1일
연구 완료 (추정된)
연구 완료
2027년 12월 15일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 3일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 29일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BIO-2026-0012
- AUB (기타 보조금/기금 번호: American University of Beirut)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .