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NCT07712887

Overview

NCT ID: NCT07712887
Lead Sponsor: American University of Beirut Medical CenterOTHER
Official Title: Puff Topography and Sensory Effects Across IQOS Device Generations: A Randomized Crossover Study
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

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Jul 27, 2026Actual
Primary Completion Date: Oct 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 50Estimated
Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Soha Talih, PhDContact
st38@aub.edu.lb+961-1-350000 ext. 3627

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Participant Group/Arms

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