Puff Topography and Sensory Effects Across IQOS Device Generations

Официальное название

Puff Topography and Sensory Effects Across IQOS Device Generations: A Randomized Crossover Study

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство IQOS 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.
• Устройство IQOS 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.

Первичные конечные точки

• Chemosensory Effects - Mouthful [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Ливан · 2 центра

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

Идентификаторы

NCT: NCT07712887 · BIO-2026-0012 · AUB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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