Effect of Waterpipe Size on Smoking Behavior and Exposures

Study Overview
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Brief Summary
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This project will generate novel evidence regarding the effect of waterpipe size on smoking behavior, toxicant exposures and subjective experiences among waterpipe smokers. Findings from this project will help the FDA in developing waterpipe size-specific regulations to curb waterpipe smoking in the US and protect public health.

Official Title
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Understanding the Effect of Waterpipe Size on Smoking Behavior, Toxicant Exposures and Subjective Experiences

Conditions
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Waterpipe Size

Intervention / Treatment
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* Other: Waterpipe size


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: regular waterpipe smokers (smoking at least once a week for the past 6 months) generally healthy and able to provide written informed consent; and willing to attend the 3 lab sessions Exclusion Criteria: history of chronic diseases such as diabetes, high blood cholesterol, hepatic disease respiratory chronic diseases cardiovascular diseases including low or high blood pressure (BP)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: waterpipe regular smokers<br>waterpipe regular smokers will be invited for 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes. | Other: Waterpipe size<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waterpipe Evaluation Scale | How participants rate their smoking experience before and after smocking different sizes of waterpipe. Is an 11-item questionnaire. This scale will be answered on a 7-point Likert scale (1-7). Higher scores indicates better satisfactory experience. | Immediately after the exposure (smoking) on the 1st lab visit (day 1) | 
| Waterpipe Evaluation Scale | How participants rate their smoking experience before and after smocking different sizes of waterpipe. Is an 11-item questionnaire. This scale will be answered on a 7-point Likert scale (1-7). Higher scores indicates better satisfactory experience. | Immediately after the exposure (smoking) on the 2nd lab visit (day 3) | 
| Waterpipe Evaluation Scale | How participants rate their smoking experience before and after smocking different sizes of waterpipe. Is an 11-item questionnaire. This scale will be answered on a 7-point Likert scale (1-7). Higher scores indicates better satisfactory experience. | Immediately after the exposure (smoking) on the 3rd lab visit (day 5) | 
| Duke Sensory Questionnaire | How participants rate their sensory experience before and after smocking different sizes of waterpipe. This scale consists of nine items. This scale will be answered on a 7-point Likert scale (1-7) anchored at the extremes (1= not at all; 7=extremely) . Higher scores indicate a better sensory experience. | Immediately after the exposure (smoking) on the 1st lab visit (day 1) | 
| Duke Sensory Questionnaire | How participants rate their sensory experience before and after smocking different sizes of waterpipe. This scale consists of nine items. This scale will be answered on a 7-point Likert scale (1-7) anchored at the extremes (1= not at all; 7=extremely) . Higher scores indicate a better sensory experience. | Immediately after the exposure (smoking) on the 2nd lab visit (day 3) | 
| Duke Sensory Questionnaire | How participants rate their sensory experience before and after smocking different sizes of waterpipe. This scale consists of nine items. This scale will be answered on a 7-point Likert scale (1-7) anchored at the extremes (1= not at all; 7=extremely) . Higher scores indicate a better sensory experience. | Immediately after the exposure (smoking) on the 3rd lab visit (day 5) | 
| Harm Perception Questionnaire | How participants rate their harm perception before and after smocking different sizes of waterpipe. This scale consists of 3 items. This scale will be answered on a 7-point Likert scale ranging from 1 (not at all harmful), to 7 (extremely harmful). | Immediately after the exposure (smoking) on the 1st lab visit (day 1) | 
| Harm Perception Questionnaire | How participants rate their harm perception before and after smocking different sizes of waterpipe. This scale consists of 3 items. This scale will be answered on a 7-point Likert scale ranging from 1 (not at all harmful), to 7 (extremely harmful). | Immediately after the exposure (smoking) on the 2nd lab visit (day 3) | 
| Harm Perception Questionnaire | How participants rate their harm perception before and after smocking different sizes of waterpipe. This scale consists of 3 items. This scale will be answered on a 7-point Likert scale ranging from 1 (not at all harmful), to 7 (extremely harmful). | Immediately after the exposure (smoking) on the 3rd lab visit (day 5) | 
| Puff topography | Puff topography will be recorded using a device integrated into the waterpipe hose and will measure how participants puffing behavior change based on the different smoked waterpipe sizes. Specifically, this outcome measure the total volume for the inhaled smoke and the volume for each puff in Liters. | During the exposure (smoking) on the 1st lab visit (day 1) | 
| Puff topography | Puff topography will be recorded using a device integrated into the waterpipe hose and will measure how participants puffing behavior change based on the different smoked waterpipe sizes. Specifically, this outcome measure the total volume for the inhaled smoke and the volume for each puff in Liters. | During the exposure (smoking) on the 2nd lab visit (day 3) | 
| Puff topography | Puff topography will be recorded using a device integrated into the waterpipe hose and will measure how participants puffing behavior change based on the different smoked waterpipe sizes. Specifically, this outcome measure the total volume for the inhaled smoke and the volume for each puff in Liters. | During the exposure (smoking) on the 3rd lab visit (day 5) | 
| Saliva nicotine | How participants' nicotine concentrations change based on the different smoked waterpipe sizes | Immediately after the exposure (smoking) on the 1st lab visit (day 1) | 
| Saliva nicotine | How participants' nicotine concentrations change based on the different smoked waterpipe sizes | Immediately after the exposure (smoking) on the 2nd lab visit (day 3) | 
| Saliva nicotine | How participants' nicotine concentrations change based on the different smoked waterpipe sizes | Immediately after the exposure (smoking) on the 3rd lab visit (day 5) |