Nicotine Dependence, Tobacco Use
Conditions
Keywords
Heated Tobacco Products, IQOS, Puff Topography, Electronic Nicotine Delivery Systems, Nicotine, Subjective Effects, Tobacco Harm Reduction
Brief summary
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
Detailed description
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.
Interventions
DEVICEIQOS 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.
DEVICEIQOS 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.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Two-visit randomized crossover design. Within each visit, participants complete two ad-libitum smoking bouts corresponding to the two device generations (IQOS Iluma i with TEREA and IQOS 2.4 with HEETS). Visit order (preferred flavor vs. Amber flavor) is randomized using block randomization; device order within each visit is randomized using a Williams design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemosensory Effects - Mouthful | 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. |
| Chemosensory Effects - Ease of draw | 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. |
| Chemosensory Effects - Throat hit | 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. |
| Mean Puff Duration | 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. |
| Number of Puffs Per Stick | 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. |
| Mean Inter-Puff Interval | 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. |
| Mean Puff Flow Rate | 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. |
| Urge to Use IQOS - Factor 1: desire/intention | 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. |
| Urge to Use IQOS - Factor 2: negative reinforcement | 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. |
| Subjective Effects of IQOS Use - satisfaction | 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. |
| Subjective Effects of IQOS Use - taste | 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. |
| Subjective Effects of IQOS Use - throat/chest sensations | 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. |
| Subjective Effects of IQOS Use - calm | 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. |
| Subjective Effects of IQOS Use - awake | 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. |
| Subjective Effects of IQOS Use - irritable | 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. |
| Subjective Effects of IQOS Use - concentration | 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. |
| Subjective Effects of IQOS Use - hungry | 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. |
| Subjective Effects of IQOS Use - dizziness | 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. |
| Subjective Effects of IQOS Use - nausea | 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. |
| Subjective Effects of IQOS Use - craving relief | 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. |
| Subjective Effects of IQOS Use - enjoyment | 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. |
Countries
Lebanon
Contacts
CONTACTSoha Talih, PhD
CONTACTMario El Hourani, PhD
PRINCIPAL_INVESTIGATORSoha Talih
American University of Beirut Medical Center
Outcome results
None listed