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NCT01048944 · ClinicalTrials.gov registry record · Phase 4
Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
A Phase 4 study, sponsored by Southern Illinois University Carbondale.
- Completed
- Registry status
- Phase 4
- Development phase
- 197
- Enrollment target
NCT01048944: Completed Phase 4 study, sponsored by Southern Illinois University Carbondale.
NCT01048944 is a Phase 4 study that has completed, run by Southern Illinois University Carbondale. The registered enrollment target is 197 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01048944, a Phase 4 study, has completed, sponsored by Southern Illinois University Carbondale.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 197 participants
- Enrollment target
Study Summary
The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2) nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week intensive post-treatment follow-up. In addition, 20 percent of the subjects will be randomized to a delayed-quit control group.
Primary Outcome
Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second \[cps\]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, del
Interventions
- DRUG Nicotine Patch
- DRUG Bupropion SR
- DRUG Placebo Patch and Placebo Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2005-06 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT01048944 record still lists
NCT01048944 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Nicotine Patch is the first listed.
NCT01048944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01048944 about?
NCT01048944 is a clinical study titled "Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers". The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers will be randomly assigned to one of ...
What is the current status of trial NCT01048944?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 197 participants. The study started on 2005-06. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01048944?
The interventions under investigation include: Nicotine Patch (DRUG), Bupropion SR (DRUG), Placebo Patch and Placebo Pill (DRUG).
Who is sponsoring clinical trial NCT01048944?
This trial is sponsored by Southern Illinois University Carbondale, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01048944's enrollment target sits among peer trials
197 448th of 2000 higher than 1,552 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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