Effect of Waterpipe Size on Smoking Behavior and Exposures

Sponsor
The University of Texas at Arlington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05705375
Collaborator
(none)
40
1
1
20.3
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Waterpipe size
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Understanding the Effect of Waterpipe Size on Smoking Behavior, Toxicant Exposures and Subjective Experiences
Actual Study Start Date :
Apr 22, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Waterpipe Evaluation Scale [Immediately after the exposure (smoking) on the 1st lab visit (day 1)]

    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.

  2. Waterpipe Evaluation Scale [Immediately after the exposure (smoking) on the 2nd lab visit (day 3)]

    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.

  3. 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.

  4. Duke Sensory Questionnaire [Immediately after the exposure (smoking) on the 1st lab visit (day 1)]

    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.

  5. Duke Sensory Questionnaire [Immediately after the exposure (smoking) on the 2nd lab visit (day 3)]

    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.

  6. 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.

  7. Harm Perception Questionnaire [Immediately after the exposure (smoking) on the 1st lab visit (day 1)]

    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).

  8. Harm Perception Questionnaire [Immediately after the exposure (smoking) on the 2nd lab visit (day 3)]

    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).

  9. 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).

  10. Puff topography [During the exposure (smoking) on the 1st lab visit (day 1)]

    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.

  11. Puff topography [During the exposure (smoking) on the 2nd lab visit (day 3)]

    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.

  12. 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.

  13. Saliva nicotine [Immediately after the exposure (smoking) on the 1st lab visit (day 1)]

    How participants' nicotine concentrations change based on the different smoked waterpipe sizes

  14. Saliva nicotine [Immediately after the exposure (smoking) on the 2nd lab visit (day 3)]

    How participants' nicotine concentrations change based on the different smoked waterpipe sizes

  15. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Texas at Arlington Arlington Texas United States 76019

Sponsors and Collaborators

  • The University of Texas at Arlington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Texas at Arlington
ClinicalTrials.gov Identifier:
NCT05705375
Other Study ID Numbers:
  • 2021-0458
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 30, 2023