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NCT04079933 · ClinicalTrials.gov registry record · NA

A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product

A NA study, sponsored by Altria Client Services.

Completed
Registry status
NA
Development phase
154
Enrollment target

NCT04079933: Completed NA study, sponsored by Altria Client Services.

NCT04079933 is a NA study that has completed, run by Altria Client Services. The registered enrollment target is 154 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04079933, a NA study, has completed, sponsored by Altria Client Services.

COMPLETED
Registry status
NA
Development phase
154 participants
Enrollment target

Study Summary

The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.

Primary Outcome

Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's b

Interventions

  • OTHER Oral tobacco-derived nicotine product (OTDN)

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 2013-08-27
Est. Completion 2013-11-26
Phase NA
Altria Client Services

10 total trials

What the finished NCT04079933 record still lists

NCT04079933 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 1 intervention - of which Oral tobacco-derived nicotine product (OTDN) is the first listed.

NCT04079933 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04079933 about?

NCT04079933 is a clinical study titled "A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product". The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.

What is the current status of trial NCT04079933?

This trial is currently completed. It is a NA study. The enrollment target is 154 participants. The study started on 2013-08-27. Estimated completion is 2013-11-26.

What interventions are being tested in trial NCT04079933?

The interventions under investigation include: Oral tobacco-derived nicotine product (OTDN) (OTHER).

Who is sponsoring clinical trial NCT04079933?

This trial is sponsored by Altria Client Services, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04079933's enrollment target sits among peer trials

154 656th of 2000 higher than 1,345 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 NCT04079933, the US trial registry maintained by the National Library of Medicine. NCT04079933 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.