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NCT01807871 · ClinicalTrials.gov registry record · Phase 4
Treatment of Smoking Lapses and Relapses
A Phase 4 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 4
- Development phase
- 701
- Enrollment target
NCT01807871: Completed Phase 4 study, sponsored by University of Vermont.
NCT01807871 is a Phase 4 study that has completed, run by University of Vermont. The registered enrollment target is 701 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807871, a Phase 4 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 701 participants
- Enrollment target
Study Summary
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a lapse and that doing so dramatically increases success at quitting. The investigators will test this by doing a randomized trial in which all treatment and measures are done from home with paper, phone or computer surveys. The investigators will recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and the other group will be asked to continue use of the patch if they lapse. The investigators will compare the groups on their success at quitting and side-effects.
Primary Outcome
To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Responden
Interventions
- DRUG nicotine patch, experimental use
- DRUG nicotine patch, labeled use
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 701 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-02 |
| Phase | Phase 4 |
What the finished NCT01807871 record still lists
NCT01807871 is an interventional study that assigns participants to a tested intervention. The registered 701 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 2 interventions - of which nicotine patch, experimental use is the first listed.
NCT01807871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01807871 about?
NCT01807871 is a clinical study titled "Treatment of Smoking Lapses and Relapses". Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a la...
What is the current status of trial NCT01807871?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 701 participants. The study started on 2013-03. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01807871?
The interventions under investigation include: nicotine patch, experimental use (DRUG), nicotine patch, labeled use (DRUG).
Who is sponsoring clinical trial NCT01807871?
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 NCT01807871's enrollment target sits among peer trials
701 114th of 2000 higher than 1,887 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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