Effect of Waterpipe Size on Smoking Behavior and Exposures

NCT05705375 | Completed Results

• 1 other identifier: 2021-0458
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Does WP size change puffing behavior?
• Does WP size change exposure to nicotine and carbon monoxide?
• Does WP size change perceptions of harm, satisfaction, craving, or withdrawal? 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.

Conditions

Waterpipe Size

Outcome Measures

Primary Outcomes (12)

• 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.

  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

Study Arms (1)

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.

Other: Waterpipe size

Interventions

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.

waterpipe regular smokers

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• history of chronic diseases such as diabetes, high blood cholesterol, hepatic disease
• respiratory chronic diseases
• cardiovascular diseases including low or high blood pressure (BP)

Sponsors & Collaborators

• The University of Texas at Arlington: lead

Study Sites (1)

University of Texas at Arlington

Arlington, Texas, 76019, United States

Location

Results Point of Contact

• Title: Ziyad Ben Taleb
• Organization: University of Texas at Arlington

ziyad.bentaleb@uta.edu

817-272-8297

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 30, 2023
• Study Start: April 22, 2022
• Primary Completion: February 28, 2024
• Study Completion: March 30, 2024
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)