Clinical trial NCT05705375: Effect of Waterpipe Size on Smoking Behavior and Exposures
Official title: Understanding the Effect of Waterpipe Size on Smoking Behavior, Toxicant Exposures and Subjective Experiences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waterpipe Size
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Waterpipe Evaluation Scale
timeFrame: Immediately after the exposure (smoking) on the 1st lab visit (day 1)
measure: Waterpipe Evaluation Scale
timeFrame: Immediately after the exposure (smoking) on the 2nd lab visit (day 3)
measure: Waterpipe Evaluation Scale
timeFrame: Immediately after the exposure (smoking) on the 3rd lab visit (day 5)
measure: Duke Sensory Questionnaire
timeFrame: Immediately after the exposure (smoking) on the 1st lab visit (day 1)
measure: Duke Sensory Questionnaire
timeFrame: Immediately after the exposure (smoking) on the 2nd lab visit (day 3)
measure: Duke Sensory Questionnaire
timeFrame: Immediately after the exposure (smoking) on the 3rd lab visit (day 5)
measure: Harm Perception Questionnaire
timeFrame: Immediately after the exposure (smoking) on the 1st lab visit (day 1)
measure: Harm Perception Questionnaire
timeFrame: Immediately after the exposure (smoking) on the 2nd lab visit (day 3)
measure: Harm Perception Questionnaire
timeFrame: Immediately after the exposure (smoking) on the 3rd lab visit (day 5)
measure: Puff topography
timeFrame: During the exposure (smoking) on the 1st lab visit (day 1)
measure: Puff topography
timeFrame: During the exposure (smoking) on the 2nd lab visit (day 3)
measure: Puff topography
timeFrame: During the exposure (smoking) on the 3rd lab visit (day 5)
measure: Saliva nicotine
timeFrame: Immediately after the exposure (smoking) on the 1st lab visit (day 1)
measure: Saliva nicotine
timeFrame: Immediately after the exposure (smoking) on the 2nd lab visit (day 3)
measure: Saliva nicotine
timeFrame: Immediately after the exposure (smoking) on the 3rd lab visit (day 5)
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: University of Texas at Arlington
state: Texas
Study officials:
References: