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NCT03060083 · ClinicalTrials.gov registry record · Phase 2
Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day
A Phase 2 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT03060083: Completed Phase 2 study, sponsored by University of Vermont.
NCT03060083 is a Phase 2 study that has completed, run by University of Vermont. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03060083, a Phase 2 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the most common method for smokers to reduce their nicotine intake is to reduce their number of cigarettes per day (CPD). No research has compared reducing smokers' nicotine intake by switching to VLNC cigarettes vs by reducing CPD with regard to decreasing dependence or quitting; thus the investigators will examine the two strategies by randomizing smokers to 1) switch to VLNC cigarettes or 2) reduce CPD. In addition, all smokers will use the nicotine patch to help them reduce their nicotine intake.
Primary Outcome
The investigators will use non-adherence to nicotine reduction (i.e., self report of percent non-study cigarettes per day) as an indicator of feasibility.
Interventions
- OTHER Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT)
- OTHER Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2017-02-08 |
| Est. Completion | 2018-01-10 |
| Phase | Phase 2 |
What the finished NCT03060083 record still lists
NCT03060083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) is the first listed.
NCT03060083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03060083 about?
NCT03060083 is a clinical study titled "Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day". The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the most common method for smo...
What is the current status of trial NCT03060083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2017-02-08. Estimated completion is 2018-01-10.
What interventions are being tested in trial NCT03060083?
The interventions under investigation include: Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) (OTHER), Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT) (OTHER).
Who is sponsoring clinical trial NCT03060083?
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 NCT03060083's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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