Puff Topography and Sensory Effects Across IQOS Device Generations
13. juli 2026 opdateret af: 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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Soha Talih, PhD
- Telefonnummer: 3627 +961-1-350000
- E-mail: st38@aub.edu.lb
Undersøgelse Kontakt Backup
- Navn: Mario El Hourani, PhD
- Telefonnummer: +96170715263
- E-mail: me217@aub.edu.lb
Studiesteder
-
-
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Beirut, Libanon
- Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Chemosensory Effects - Mouthful
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 - irritable
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Soha Talih, American University of Beirut Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
20. juli 2026
Primær færdiggørelse (Anslået)
1. oktober 2027
Studieafslutning (Anslået)
15. december 2027
Datoer for studieregistrering
Først indsendt
3. juli 2026
Først indsendt, der opfyldte QC-kriterier
13. juli 2026
Først opslået (Faktiske)
20. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juli 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BIO-2026-0012
- AUB (Andet bevillings-/finansieringsnummer: American University of Beirut)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .