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NCT05730439 · ClinicalTrials.gov registry record · Early Phase 1

Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia

A Early Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
Early Phase 1
Development phase
71
Enrollment target

NCT05730439: Completed Early Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.

NCT05730439 is a Early Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 71 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05730439, a Early Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

COMPLETED
Registry status
Early Phase 1
Development phase
71 participants
Enrollment target

Study Summary

This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.

Primary Outcome

Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to assess the effects of product type on plasma nicotine delivery. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.

Interventions

  • PROCEDURE Biospecimen Collection
  • OTHER Questionnaire Administration
  • DRUG Nicotine Oral Pouch
  • DRUG Smokeless Tobacco

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2023-05-19
Est. Completion 2024-08-05
Phase Early Phase 1

What the finished NCT05730439 record still lists

NCT05730439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% higher).

The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.

NCT05730439 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05730439 about?

NCT05730439 is a clinical study titled "Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia". This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine ...

What is the current status of trial NCT05730439?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 71 participants. The study started on 2023-05-19. Estimated completion is 2024-08-05.

What interventions are being tested in trial NCT05730439?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Nicotine Oral Pouch (DRUG), Smokeless Tobacco (DRUG).

Who is sponsoring clinical trial NCT05730439?

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 NCT05730439's enrollment target sits among peer trials

71 328th of 2000 higher than 1,663 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 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 NCT05730439, the US trial registry maintained by the National Library of Medicine. NCT05730439 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.