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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
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.
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.
Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
Beirut, Beirut, Lebanon
RECRUITINGClinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
Beirut, Lebanon
RECRUITINGChemosensory Effects - Mouthful
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
Mean duration (seconds) of each puff recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Time frame: 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
Total number of puffs taken per tobacco stick during each ad-libitum smoking bout, recorded using the eTOP puff topography instrument.
Time frame: 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
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.
Time frame: 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
Mean peak puff flow rate (mL/s) recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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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