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The goal of this clinical trial is to learn how waterpipe (WP) size affects smoking behavior, toxicant exposure, and subjective experiences in young adult WP smokers (ages 21-39). The main questions it aims to answer are:
Participants will smoke small, medium, and large WPs in separate sessions. Researchers will measure puffing behavior, saliva nicotine, exhaled carbon monoxide, and survey responses before and after each session.
This study will examine the effect of waterpipe (WP) size manipulation on smoking behavior, toxicant exposure, and subjective experiences among young adult WP smokers. A total of 40 participants ages 21-39 will complete a 2x3 crossover design, where the within-subject factors are time (pre vs. post WP smoking) and study condition (small vs. medium vs. large). Each participant will attend three 45-minute laboratory sessions, each using a different WP size.
Aim 1: To examine the effect of WP size on puffing behavior and toxicant exposure. Puff topography parameters (puff number, duration, average puff volume, total inhaled volume, and inter-puff interval) will be measured during smoking. Exhaled CO and saliva nicotine concentrations will be measured pre- and post-session.
Aim 2: To examine the effect of WP size on harm perception and subjective experiences. Outcomes include harm perception, WP Evaluation Scale, Duke Sensory Questionnaire, Questionnaire of Smoking Urges (brief), and Minnesota Nicotine Withdrawal Scale.
This project will generate novel evidence on how WP size influences smoking behavior, exposure to nicotine and CO, and user perceptions. Findings will inform the FDA on the potential impact of WP size regulation and help guide the development of size-specific standards to protect public health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| waterpipe regular smokers | Experimental | waterpipe regular smokers will be invited for 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Waterpipe size | Other | Participants will have 3 lab visits where they are allocated (random order) to smoke a small waterpipe in one visit, smoke a medium waterpipe in a second visit and smoke a large waterpipe in a third visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Waterpipe Evaluation Scale | An 11-item questionnaire assessing participants' subjective experience of smoking waterpipe (WP) tobacco. Each item is scored on a 7-point Likert scale (1 = "not at all" to 7 = "extremely"). For analysis, item scores were averaged across the 11 items to produce a mean WES score for each WP size, with higher scores indicating a more satisfactory smoking experience. The scale captures aspects such as satisfaction, taste, cravings, and sensory enjoyment in the throat and chest. | Immediately after the exposure (smoking) |
| Duke Sensory Questionnaire | A 9-item questionnaire assessing participants' sensory experience of smoking waterpipe (WP) tobacco. Each item is scored on a 7-point Likert scale (1 = "not at all" to 7 = "extremely"). Item scores were averaged across the 9 items to produce a mean DSQ score for each WP size, with higher scores indicating a more positive sensory experience (e.g., satisfaction, perceived nicotine strength, and puff intensity). | Immediately after the exposure (smoking) |
| Harm Perception Questionnaire | This is a 3-item scale assessing participants' perception of the harmfulness of waterpipe (WP) tobacco smoking. Each item is scored on a 7-point Likert scale ranging from 1 = "a lot less harmful" to 7 = "a lot more harmful." Item scores were averaged across the 3 items to produce a mean harm perception score for each WP size, with higher scores indicating greater perceived harm. | Immediately after the exposure (smoking) |
| Saliva Nicotine | How participants' nicotine concentrations change based on the different smoked waterpipe sizes | Immediately after the exposure (smoking) |
| Puff Topography: Smoking Time | The total time spent smoking during a single WP session, measured in minutes. Longer times indicate greater duration of smoking across WP sizes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Arlington | Arlington | Texas | 76019 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Small → Medium → Large | Participants first smoke the small WP in Session 1, followed by the medium WP in Session 2, and the large WP in Session 3. Each session lasts 45 minutes and is separated by a 48-hour washout period. |
| FG001 | Small → Large → Medium | Participants first smoke the small WP, then the large WP, and finally the medium WP, with each 45-minute session separated by a 48-hour washout. |
| FG002 | Medium → Large → Small | Participants first smoke the medium WP, then the large WP, and finally the small WP, with each 45-minute session separated by a 48-hour washout. |
| FG003 | Medium → Small → Large | Participants first smoke the medium WP, then the small WP, and finally the large WP, with each 45-minute session separated by a 48-hour washout. |
| FG004 | Large → Medium → Small | Participants first smoke the large WP, then the medium WP, and finally the small WP, with each 45-minute session separated by a 48-hour washout. |
| FG005 | Large → Small → Medium | Participants first smoke the large WP, then the small WP, and finally the medium WP, with each 45-minute session separated by a 48-hour washout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout (48 Hours) |
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| Second Intervention (1 Day) |
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| Washout (48 Hours) |
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| Third Intervention (1 Day) |
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waterpipe regular smokers will be invited for 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes.
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| ID | Title | Description |
|---|---|---|
| BG000 | Waterpipe Regular Smokers | waterpipe regular smokers will be invited for 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. Waterpipe size: Participants will have 3 lab visits where they are allocated (random order) to smoke a small waterpipe in one visit, smoke a medium waterpipe in a second visit and smoke a large waterpipe in a third visit. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Waterpipe Evaluation Scale | An 11-item questionnaire assessing participants' subjective experience of smoking waterpipe (WP) tobacco. Each item is scored on a 7-point Likert scale (1 = "not at all" to 7 = "extremely"). For analysis, item scores were averaged across the 11 items to produce a mean WES score for each WP size, with higher scores indicating a more satisfactory smoking experience. The scale captures aspects such as satisfaction, taste, cravings, and sensory enjoyment in the throat and chest. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the exposure (smoking) |
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Each participant was monitored during and immediately after three laboratory smoking sessions (~45 minutes each) separated by ≥48 hours (~1 week total monitoring per participant). This monitoring process was carried out for all participants over the approximate 23-month study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Small Waterpipe | waterpipe regular smokers attended 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ziyad Ben Taleb | University of Texas at Arlington | 817-272-8297 | ziyad.bentaleb@uta.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2025 | Sep 16, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2024 | Jun 3, 2024 | ICF_000.pdf |
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| During the exposure (smoking), up to 45 mins |
| Puff Topography: Cumulative Puff Time | The total time spent actively inhaling smoke across all puffs in a WP session, measured in minutes using a puff topography device. Higher values indicate more total inhalation time. | During the exposure (smoking), up to 45 mins |
| Puff Topography: Puff Duration | The average length of each puff in seconds, measured using a puff topography device in the WP hose. Longer puff duration indicates deeper inhalation per puff. | During the exposure (smoking), up to 45 mins |
| Puff Topography: Average Flow Rate | The average rate of smoke inhaled per second during puffing, measured in liters per minute with a puff topography device. Higher flow rates indicate faster inhalation. | During the exposure (smoking), up to 45 mins |
| Puff Topography: Number of Puffs | The total number of puffs taken during a WP session, measured using a puff topography device. Higher counts indicate more frequent puffing. | During the exposure (smoking), up to 45 mins |
| Puff Topography: Total Smoke Volume Inhaled | Total smoke inhaled during a single WP session, measured in liters using a puff topography device in the WP hose. Higher values indicate greater smoke intake across WP sizes. | During the exposure (smoking), up to 45 mins |
| Puff Topography: Puff Volume Average | Mean volume of each puff during a WP session, measured in liters using a puff topography device in the WP hose. Higher values indicate larger puff sizes across WP sizes. | During the exposure (smoking), up to 45 mins |
| Puff Topography: Maximum Puff Volume | The largest single puff volume inhaled during a WP session, measured in liters using a puff topography device. Higher values indicate the strongest inhalation effort across puffs. | During the exposure (smoking), up to 45 mins |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Saliva Nicotine | Mean | Standard Deviation | ng/mL |
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| Exhaled Carbon Monoxide | Mean | Standard Deviation | PPM |
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waterpipe regular smokers attended 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. |
| OG002 | Large Waterpipe | waterpipe regular smokers attended 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. |
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| Primary | Duke Sensory Questionnaire | A 9-item questionnaire assessing participants' sensory experience of smoking waterpipe (WP) tobacco. Each item is scored on a 7-point Likert scale (1 = "not at all" to 7 = "extremely"). Item scores were averaged across the 9 items to produce a mean DSQ score for each WP size, with higher scores indicating a more positive sensory experience (e.g., satisfaction, perceived nicotine strength, and puff intensity). | Posted | Mean | Standard Deviation | units on a scale | Immediately after the exposure (smoking) |
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| Primary | Harm Perception Questionnaire | This is a 3-item scale assessing participants' perception of the harmfulness of waterpipe (WP) tobacco smoking. Each item is scored on a 7-point Likert scale ranging from 1 = "a lot less harmful" to 7 = "a lot more harmful." Item scores were averaged across the 3 items to produce a mean harm perception score for each WP size, with higher scores indicating greater perceived harm. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the exposure (smoking) |
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| Primary | Saliva Nicotine | How participants' nicotine concentrations change based on the different smoked waterpipe sizes | A small number of participants could not provide adequate saliva nicotine samples due to technical issues encountered during the collection process | Posted | Mean | Standard Error | ng/mL | Immediately after the exposure (smoking) |
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| Primary | Puff Topography: Smoking Time | The total time spent smoking during a single WP session, measured in minutes. Longer times indicate greater duration of smoking across WP sizes. | Posted | Mean | Standard Deviation | Minutes | During the exposure (smoking), up to 45 mins |
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| Primary | Puff Topography: Cumulative Puff Time | The total time spent actively inhaling smoke across all puffs in a WP session, measured in minutes using a puff topography device. Higher values indicate more total inhalation time. | Posted | Mean | Standard Deviation | Minutes | During the exposure (smoking), up to 45 mins |
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| Primary | Puff Topography: Puff Duration | The average length of each puff in seconds, measured using a puff topography device in the WP hose. Longer puff duration indicates deeper inhalation per puff. | Posted | Mean | Standard Deviation | Seconds | During the exposure (smoking), up to 45 mins |
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| Primary | Puff Topography: Average Flow Rate | The average rate of smoke inhaled per second during puffing, measured in liters per minute with a puff topography device. Higher flow rates indicate faster inhalation. | Posted | Mean | Standard Deviation | L/min | During the exposure (smoking), up to 45 mins |
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| Primary | Puff Topography: Number of Puffs | The total number of puffs taken during a WP session, measured using a puff topography device. Higher counts indicate more frequent puffing. | Posted | Mean | Standard Deviation | Puffs | During the exposure (smoking), up to 45 mins |
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| Primary | Puff Topography: Total Smoke Volume Inhaled | Total smoke inhaled during a single WP session, measured in liters using a puff topography device in the WP hose. Higher values indicate greater smoke intake across WP sizes. | Posted | Mean | Standard Deviation | Liters | During the exposure (smoking), up to 45 mins |
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| Primary | Puff Topography: Puff Volume Average | Mean volume of each puff during a WP session, measured in liters using a puff topography device in the WP hose. Higher values indicate larger puff sizes across WP sizes. | Posted | Mean | Standard Deviation | Liters | During the exposure (smoking), up to 45 mins |
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| Primary | Puff Topography: Maximum Puff Volume | The largest single puff volume inhaled during a WP session, measured in liters using a puff topography device. Higher values indicate the strongest inhalation effort across puffs. | Posted | Mean | Standard Deviation | Liters | During the exposure (smoking), up to 45 mins |
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| 0 |
| 40 |
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| 40 |
| 0 |
| 40 |
| EG001 | Medium Waterpipe | waterpipe regular smokers attended 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | Large Waterpipe | waterpipe regular smokers attended 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. | 0 | 40 | 0 | 40 | 0 | 40 |
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