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NCT05453773 · ClinicalTrials.gov registry record · NA

Hookah Additive Research to Inform Product Standards

A NA study, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
NA
Development phase
54
Enrollment target

NCT05453773: Completed NA study, sponsored by Ohio State University Comprehensive Cancer Center.

NCT05453773 is a NA study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05453773, a NA study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

COMPLETED
Registry status
NA
Development phase
54 participants
Enrollment target

Study Summary

This clinical trial evaluates how the content of waterpipe (WP) tobacco affects the appeal, puffing behavior, and toxicity of WP tobacco smoking. The data from the proposed study will provide direct links between WP tobacco's primary additives (sugars and humectants), CO and nicotine biomarkers, smoker preferences, perceptions of harm and puffing behaviors, and the subsequent range of toxicant exposures associated with these additives and behaviors. Study outcomes include waterpipe puffing behaviors, exhaled carbon monoxide levels, nicotine uptake, spirometry, sensory perceptions, smoking appeal, and risk perception. Waterpipe tobacco smoking is often the first combustible tobacco product tried by adolescents and young adults, possibly due to the widespread availability of heavily sweetened waterpipe tobacco and the perception that waterpipe smoking is a safer alternative to cigarette smoking. However, waterpipe tobacco smoking is associated with lung disease, carbon monoxide poisoning, and precursor conditions for oral and other cancers in adolescents and young adults. There is currently little data available on how the primary additives (by weight) in waterpipe tobacco affect puffing behaviors, toxicant exposures, pulmonary function and appeal. This clinical trial uses established waterpipe tobacco smokers, four investigational tobacco products with precisely manipulated levels of humectants and natural sugars in a single-blind, crossover (repeated measures) study design to determine how waterpipe tobacco additives effect human puffing behavior, nicotine uptake, flavor perceptions, lung function, and biomarkers of exposure.

Primary Outcome

Change from baseline exhaled breath carbon monoxide (boost). CO was collected before and immediately after each smoking session with a handheld electrochemical cell.

Interventions

  • OTHER Questionnaire Administration
  • BEHAVIORAL Tobacco Smoking

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2022-06-19
Est. Completion 2023-05-11
Phase NA

What the finished NCT05453773 record still lists

NCT05453773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Questionnaire Administration is the first listed.

NCT05453773 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05453773 about?

NCT05453773 is a clinical study titled "Hookah Additive Research to Inform Product Standards". This clinical trial evaluates how the content of waterpipe (WP) tobacco affects the appeal, puffing behavior, and toxicity of WP tobacco smoking. The data from the proposed study will provide direct links between WP tobacco's primary additives (sugars and humectants), CO and nicotine biomarkers, smo...

What is the current status of trial NCT05453773?

This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2022-06-19. Estimated completion is 2023-05-11.

What interventions are being tested in trial NCT05453773?

The interventions under investigation include: Questionnaire Administration (OTHER), Tobacco Smoking (BEHAVIORAL).

Who is sponsoring clinical trial NCT05453773?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05453773's enrollment target sits among peer trials

54 1268th of 2000 higher than 730 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 NCT05453773, the US trial registry maintained by the National Library of Medicine. NCT05453773 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.