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NCT03253653 · ClinicalTrials.gov registry record · NA
Assessing Toxicity of Waterpipe Tobacco Smoking
A NA study, sponsored by San Diego State University.
- Completed
- Registry status
- NA
- Development phase
- 85
- Enrollment target
NCT03253653 is a NA study that has completed, run by San Diego State University. The registered enrollment target is 85 participants.
The verdict
NCT03253653, a NA study, has completed, sponsored by San Diego State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
Study Summary
Waterpipe smoking is a tobacco use method in which smoke passes through a partially-filled water jar. Burning charcoal heats the waterpipe tobacco which produces the smoke that the user inhales. Waterpipe smoking was associated with increased risk for coronary heart and pulmonary diseases. This Waterpipe Study will inform the FDA on regulating waterpipe tobacco products and reduce the harm of it use. This study will be conducted at homes of hookah smokers, in natural settings, aimed to determine the effects of waterpipe smoking practices on physiological injury markers and biomarkers of toxicity of waterpipe tobacco smoking. The investigators will employ a repeated measures design. The investigators will recruit a sample of 50 adult male and female exclusive waterpipe smokers and a control sample of 25 male and female non-smokers via intercept interviews from San Diego County, California communities. Waterpipe smokers will smoke one waterpipe tobacco head (10g) of Starbuzz during 3 separate sessions with a 7-day washout period before each session, as follows: Session 1, Smoking waterpipe tobacco using 1 quick-light charcoal and room temperature water in the waterpipe jar, Session 2, Smoking waterpipe tobacco using 1 quick-light charcoal and adding ice cubes to the water in the waterpipe jar, and Session 3, Smoking waterpipe tobacco without charcoal using a charcoal-free electrically heated waterpipe head to heat the tobacco, and room temperature water in the waterpipe jar. The following data will be collected: a) Tobacco Use History, b) 4-week Tobacco Exposure Diary, c) Waterpipe Use Session Form, d) Carbon monoxide (CO) exposure: Micro+ Smokerlyzer® CO monitor will be used for exhaled CO pre and 2 minutes post each smoking session, e) Pulmonary function testing and measuring blood pressure, heart rate and respiratory rate, and f) 6 first morning urine samples: pre and post the 3 sessions to measure urinary cotinine, a metabolite of nicotine, 4-(methylnitrosamino)-1
Interventions
- DEVICE Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2018-09-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03253653
The ClinicalTrials.gov registry entry for NCT03253653 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is San Diego State University, which has 118 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke is the first listed.
NCT03253653 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03253653 about?
NCT03253653 is a clinical study titled "Assessing Toxicity of Waterpipe Tobacco Smoking". Waterpipe smoking is a tobacco use method in which smoke passes through a partially-filled water jar. Burning charcoal heats the waterpipe tobacco which produces the smoke that the user inhales. Waterpipe smoking was associated with increased risk for coronary heart and pulmonary diseases. This Wate...
What is the current status of trial NCT03253653?
This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2017-10-20. Estimated completion is 2018-09-25.
What interventions are being tested in trial NCT03253653?
The interventions under investigation include: Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke (DEVICE).
Who is sponsoring clinical trial NCT03253653?
This trial is sponsored by San Diego State University, which has 118 total clinical trials registered on ClinicalTrials.gov.
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