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NCT00578669 · ClinicalTrials.gov registry record · Phase 3
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
A Phase 3 study, sponsored by Butler Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
NCT00578669: Completed Phase 3 study, sponsored by Butler Hospital.
NCT00578669 is a Phase 3 study that has completed, run by Butler Hospital. The registered enrollment target is 206 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578669, a Phase 3 study, has completed, sponsored by Butler Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether, among smokers with elevated depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun 8 weeks prior to and extended throughout standard smoking cessation treatment with transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking cessation outcomes compared to sequential pharmacotherapy with placebo medication combined with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower levels of depressive symptoms and negative mood and higher levels of positive mood immediately prior to and throughout the course of smoking cessation treatment relative to the placebo condition.
Primary Outcome
7-day point prevalence abstinence
Interventions
- DRUG Fluoxetine
- DRUG Dextrose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT00578669 record still lists
NCT00578669 is an interventional study that assigns participants to a tested intervention. The registered 206 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 (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluoxetine is the first listed.
NCT00578669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00578669 about?
NCT00578669 is a clinical study titled "Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms". The primary purpose of this study is to determine whether, among smokers with elevated depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun 8 weeks prior to and extended throughout standard smoking cessation treatment with transdermal nicotine patch (ST-TNP) w...
What is the current status of trial NCT00578669?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2008-04. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00578669?
The interventions under investigation include: Fluoxetine (DRUG), Dextrose (DRUG).
Who is sponsoring clinical trial NCT00578669?
This trial is sponsored by Butler Hospital, which has 103 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00578669's enrollment target sits among peer trials
206 1347th of 2000 higher than 651 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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