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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: Completed NA study, sponsored by San Diego State University.

NCT03253653 is a NA study that has completed, run by San Diego State University. The registered enrollment target is 85 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Investigators will assess change in creatinine-adjusted urinary levels of cotinine (a metabolite of the addictive drug nicotine) in ng/mL, from pre-to post, at each of 2 waterpipe tobacco smoking sessions. For each of the 2 smoking sessions, smokers will provide two first morning spot urine samples--the day of the smoking session and the following morning. The two waterpipe tobacco smoking sessions are as follows: 1) using charcoal to heat the tobacco, and 2) using a charcoal-free electronic wat

Interventions

  • DEVICE Differential effects of waterpipe smoking practices on toxicity of waterpipe tobacco smoke

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2017-10-20
Est. Completion 2018-09-25
Phase NA
San Diego State University

118 total trials

What the finished NCT03253653 record still lists

NCT03253653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03253653's enrollment target sits among peer trials

85 980th of 2000 higher than 1,018 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03253653, the US trial registry maintained by the National Library of Medicine. NCT03253653 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.