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NCT02250534 · ClinicalTrials.gov registry record · Phase 1
Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
A Phase 1 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 1
- Development phase
- 775
- Enrollment target
NCT02250534: Completed Phase 1 study, sponsored by University of Vermont.
NCT02250534 is a Phase 1 study that has completed, run by University of Vermont. The registered enrollment target is 775 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02250534, a Phase 1 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 775 participants
- Enrollment target
Study Summary
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including cervical cancer, thrombosis related to hormone-based contraception, infertility, and early menopause. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like disadvantaged women who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.
Primary Outcome
Participant reported number of cigarettes smoked per day at Week 12.
Interventions
- OTHER Very low nicotine content cigarettes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 775 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-10 |
| Phase | Phase 1 |
What the finished NCT02250534 record still lists
NCT02250534 is an interventional study that assigns participants to a tested intervention. The registered 775 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1192% higher).
The record links to 0 conditions, and to 1 intervention - of which Very low nicotine content cigarettes is the first listed.
NCT02250534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02250534 about?
NCT02250534 is a clinical study titled "Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women". This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse...
What is the current status of trial NCT02250534?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 775 participants. The study started on 2016-10. Estimated completion is 2019-10.
What interventions are being tested in trial NCT02250534?
The interventions under investigation include: Very low nicotine content cigarettes (OTHER).
Who is sponsoring clinical trial NCT02250534?
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 NCT02250534's enrollment target sits among peer trials
775 15th of 2000 higher than 1,986 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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