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NCT04033237 · ClinicalTrials.gov registry record · Phase 1
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
A Phase 1 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04033237: Completed Phase 1 study, sponsored by University of Vermont.
NCT04033237 is a Phase 1 study that has completed, run by University of Vermont. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04033237, a Phase 1 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.
Interventions
- OTHER Very low nicotine content cigarettes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-08-21 |
| Est. Completion | 2024-08-19 |
| Phase | Phase 1 |
What the finished NCT04033237 record still lists
NCT04033237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Very low nicotine content cigarettes is the first listed.
NCT04033237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04033237 about?
NCT04033237 is a clinical study titled "Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women". Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking r...
What is the current status of trial NCT04033237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-08-21. Estimated completion is 2024-08-19.
What interventions are being tested in trial NCT04033237?
The interventions under investigation include: Very low nicotine content cigarettes (OTHER).
Who is sponsoring clinical trial NCT04033237?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04033237's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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