Puff Topography and Sensory Effects Across IQOS Device Generations

NCT07712887 | Recruiting

• 2 other identifiers: BIO-2026-0012AUB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Nicotine Dependence; Tobacco Use

Keywords

Heated Tobacco Products; IQOS; Puff Topography; Electronic Nicotine Delivery Systems; Nicotine; Subjective Effects; Tobacco Harm Reduction

Outcome Measures

Primary Outcomes (21)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)

Study Arms (2)

IQOS Iluma i (Induction Heating)

EXPERIMENTAL

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.

Device: IQOS Iluma i with TEREA Tobacco Sticks

IQOS 2.4 (Blade Heating)

ACTIVE COMPARATOR

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.

Device: IQOS 2.4 with HEETS Tobacco Sticks

Interventions

IQOS 2.4 with HEETS Tobacco Sticks DEVICE

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.

IQOS 2.4 (Blade Heating)

IQOS Iluma i with TEREA Tobacco Sticks DEVICE

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.

IQOS Iluma i (Induction Heating)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (2)

Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut

Beirut, Beirut, 1107 2020, Lebanon

RECRUITING

Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Smoking

Study Officials

• Soha Talih

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soha Talih, PhD

CONTACT

+961-1-350000; st38@aub.edu.lb

Mario El Hourani, PhD

CONTACT

+96170715263; me217@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 20, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (2)