Effect of Waterpipe Size on Smoking Behavior and Exposures

Not Applicable

Completed

• Conditions: Waterpipe Size
• Interventions: Other: Waterpipe size

• Registration Number: NCT05705375
• Lead Sponsor: The University of Texas at Arlington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-22
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-30
• Primary Completion: 2024-02-28
• Study Completion: 2024-03-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
waterpipe regular smokers	Waterpipe size	waterpipe regular smokers will be invited for 3 lab visits where they are allocated (random order) to smoke 3 waterpipe different sizes.

Primary Outcome Measures

Name	Time	Method
Waterpipe Evaluation Scale	Immediately after the exposure (smoking) on the 3rd lab visit (day 5)	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.
Duke Sensory Questionnaire	Immediately after the exposure (smoking) on the 3rd lab visit (day 5)	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.
Harm Perception Questionnaire	Immediately after the exposure (smoking) on the 3rd lab visit (day 5)	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).
Saliva nicotine	Immediately after the exposure (smoking) on the 3rd lab visit (day 5)	How participants' nicotine concentrations change based on the different smoked waterpipe sizes
Puff topography	During the exposure (smoking) on the 3rd lab visit (day 5)	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.

Trial Locations

Locations (1)

University of Texas at Arlington; 🇺🇸 Arlington, Texas, United States