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NCT02232737 · ClinicalTrials.gov registry record · Phase 1
Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
A Phase 1 study of Tobacco Use Disorder, sponsored by Brown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 775
- Enrollment target
- 2
- Study locations
NCT02232737 is a Phase 1 study of Tobacco Use Disorder that has completed, run by Brown University. The registered enrollment target is 775 participants, above the 228-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (240% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT02232737, a Phase 1 study of Tobacco Use Disorder, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 775 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders 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 site-specific cancers, heart disease, and premature death. 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 those with affective disorders 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.
Conditions Studied
Interventions
- OTHER Very low nicotine content cigarettes
Study Locations (2)
Rhode Island
- Brown University - Providence
Vermont
- University of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 775 participants |
| Start Date | 2016-10-07 |
| Est. Completion | 2019-01-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02232737
The ClinicalTrials.gov registry entry for NCT02232737 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 775 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 228-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (240% higher). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Very low nicotine content cigarettes is the first listed.
NCT02232737 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Rhode Island, Vermont.
Frequently Asked Questions
What is clinical trial NCT02232737 about?
NCT02232737 is a clinical study titled "Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders". This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-rel...
What is the current status of trial NCT02232737?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 775 participants. The study started on 2016-10-07. Estimated completion is 2019-01-14.
What conditions does trial NCT02232737 study?
This clinical trial studies the following conditions: Tobacco Use Disorder.
What interventions are being tested in trial NCT02232737?
The interventions under investigation include: Very low nicotine content cigarettes (OTHER).
Who is sponsoring clinical trial NCT02232737?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02232737 being conducted?
This trial has 2 study locations across Rhode Island, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.