Puff Topography and Sensory Effects Across IQOS Device Generations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAmerican University of Beirut Medical Center
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
IQOS Iluma i with TEREA Tobacco Sticks
DeviceThe 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.
IQOS 2.4 with HEETS Tobacco Sticks
DeviceThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: IQOS Iluma i (Induction Heating)Experimental treatment 1 intervention
Group B: IQOS 2.4 (Blade Heating)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Chemosensory 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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov