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NCT03692078 · ClinicalTrials.gov registry record · NA
A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.
A NA study, sponsored by Altria Client Services.
- Completed
- Registry status
- NA
- Development phase
- 231
- Enrollment target
NCT03692078: Completed NA study, sponsored by Altria Client Services.
NCT03692078 is a NA study that has completed, run by Altria Client Services. The registered enrollment target is 231 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03692078, a NA study, has completed, sponsored by Altria Client Services.
- COMPLETED
- Registry status
- NA
- Development phase
- 231 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.
Primary Outcome
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on D
Interventions
- OTHER OTDN product 1
- OTHER OTDN product 2
- OTHER Tobacco Cessation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2018-10-01 |
| Phase | NA |
What the finished NCT03692078 record still lists
NCT03692078 is an interventional study that assigns participants to a tested intervention. The registered 231 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 (84% lower).
The record links to 0 conditions, and to 3 interventions - of which OTDN product 1 is the first listed.
NCT03692078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03692078 about?
NCT03692078 is a clinical study titled "A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.". The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who cont...
What is the current status of trial NCT03692078?
This trial is currently completed. It is a NA study. The enrollment target is 231 participants. The study started on 2018-05-30. Estimated completion is 2018-10-01.
What interventions are being tested in trial NCT03692078?
The interventions under investigation include: OTDN product 1 (OTHER), OTDN product 2 (OTHER), Tobacco Cessation (OTHER).
Who is sponsoring clinical trial NCT03692078?
This trial is sponsored by Altria Client Services, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03692078's enrollment target sits among peer trials
231 465th of 2000 higher than 1,536 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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