Effect of Waterpipe Size on Smoking Behavior and Exposures

NCT ID: NCT05705375

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2024-03-30

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.

Detailed Description

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.

Conditions

Waterpipe Size

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Waterpipe size

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas at Arlington

Arlington, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2021-0458

Identifier Type: -

Identifier Source: org_study_id