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NCT02250664 · ClinicalTrials.gov registry record · Phase 1
Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
A Phase 1 study of Tobacco Use Disorder, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 1
- Development phase
- 775
- Enrollment target
- 2
- Study locations
NCT02250664 is a Phase 1 study of Tobacco Use Disorder that has completed, run by University of Vermont. 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
NCT02250664, a Phase 1 study of Tobacco Use Disorder, has completed, sponsored by University of Vermont.
- 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 adults with opioid use disorder. Those with opioid use disorder 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 opioid use disorder 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)
Maryland
- Johns Hopkins University - Baltimore
Vermont
- University of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 775 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02250664
The ClinicalTrials.gov registry entry for NCT02250664 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 University of Vermont, which has 162 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.
NCT02250664 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Vermont.
Frequently Asked Questions
What is clinical trial NCT02250664 about?
NCT02250664 is a clinical study titled "Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers". This study will examine extended exposure to cigarettes varying in nicotine content among adults with opioid use disorder. Those with opioid use disorder are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for ...
What is the current status of trial NCT02250664?
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 conditions does trial NCT02250664 study?
This clinical trial studies the following conditions: Tobacco Use Disorder.
What interventions are being tested in trial NCT02250664?
The interventions under investigation include: Very low nicotine content cigarettes (OTHER).
Who is sponsoring clinical trial NCT02250664?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02250664 being conducted?
This trial has 2 study locations across Maryland, 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
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