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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: Completed Phase 1 study of Tobacco Use Disorder, sponsored by University of Vermont.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participant reported number of cigarettes smoked per day at Week 12
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 |
What the finished NCT02250664 record still lists
NCT02250664 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 228-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (240% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Tobacco Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02250664's enrollment target sits among peer trials
775 6th of 70 higher than 64 of 70 other Tobacco Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use Disorder 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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