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NCT01047527 · ClinicalTrials.gov registry record · Phase 4
An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 525
- Enrollment target
NCT01047527: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT01047527 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 525 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01047527, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 525 participants
- Enrollment target
Study Summary
The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.
Interventions
- DRUG Transdermal nicotine patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2009-06 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01047527
The ClinicalTrials.gov registry entry for NCT01047527 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 525 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transdermal nicotine patch is the first listed.
NCT01047527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01047527 about?
NCT01047527 is a clinical study titled "An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence". The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only ...
What is the current status of trial NCT01047527?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 525 participants. The study started on 2009-06. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01047527?
The interventions under investigation include: Transdermal nicotine patch (DRUG).
Who is sponsoring clinical trial NCT01047527?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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