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NCT00364156 · ClinicalTrials.gov registry record · Phase 3
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
A Phase 3 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
NCT00364156: Completed Phase 3 study, sponsored by University of Pennsylvania.
NCT00364156 is a Phase 3 study that has completed, run by University of Pennsylvania. The registered enrollment target is 568 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00364156, a Phase 3 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
Study Summary
This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.
Primary Outcome
To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.
Interventions
- DRUG Standard Patch Treatment
- DRUG 24-weeks of nicotine patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2004-06 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
What the finished NCT00364156 record still lists
NCT00364156 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Patch Treatment is the first listed.
NCT00364156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00364156 about?
NCT00364156 is a clinical study titled "Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation". This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment...
What is the current status of trial NCT00364156?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2004-06. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00364156?
The interventions under investigation include: Standard Patch Treatment (DRUG), 24-weeks of nicotine patch (DRUG).
Who is sponsoring clinical trial NCT00364156?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00364156's enrollment target sits among peer trials
568 666th of 2000 higher than 1,334 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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