Effect of Waterpipe Size on Smoking Behavior and Exposures

The University of Texas System (UT)

Status

Completed

Conditions

Waterpipe Size

Treatments

Other: Waterpipe size

Study type

Interventional

Funder types

Other

Identifiers

NCT05705375

2021-0458

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

21 to 39 years old

Volunteers

Accepts Healthy Volunteers

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)