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NCT01056926 · ClinicalTrials.gov registry record · Phase 1
Neurobiology of Nicotine and Non-nicotine Components of Tobacco Addiction
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 147
- Enrollment target
NCT01056926: Completed Phase 1 study, sponsored by Duke University.
NCT01056926 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 147 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01056926, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 147 participants
- Enrollment target
Study Summary
In the present study the investigators will measure the effects of nicotine and non-nicotine factors on brain function during cognitive processes that are differentially sensitive to these factors. One process-continuous working memory (CWM)-is implemented via a network of frontal and parietal brain regions and is highly dopamine dependent. Smoking cessation results in significant deficits in CWM which can persist for weeks and are reversed by resumption of nicotine administration in the form of smoking or nicotine replacement. Additionally, CWM deficits are observed during smoking of denic cigarettes. Brain function during CWM is modulated by smoking abstinence and subsequent nicotine administration and activity in the dlPFC is implicated in these effects. Collectively, these data suggest that CWM is highly sensitive to the nicotine, but not non-nicotine components of smoking. Brain function during CWM is altered by smoking abstinence and nicotine, but the effect of smoking, in the absence of nicotine, has not been evaluated. Another process-cue-reactivity (CR)-results from the repeated pairing of otherwise neutral stimuli with nicotine administration. Acute smoking cessation has not been shown to have strong effects on CR in the form of cue-provoked craving, nor has nicotine replacement been shown to have robust effects on CR. Likewise, the direct effects of smoking abstinence on brain CR have been small; though craving has been shown to modulate relations between abstinence and CR. Moreover, recent data from our lab suggest larger 'doses' of abstinence (\~ 24 hrs) may amplify brain responses to cues. The effect of smoking in the absence of nicotine, on CR has not, to our knowledge, been evaluated. Collectively, these data suggest that CR in the form of cue-induced craving is not highly sensitive to the effects of short-term smoking abstinence or nicotine. Brain CR is modulated by abstinence-induced craving and longer-term abstinence, but it is unclear whether ab
Interventions
- DRUG Placebo Patch
- DRUG Nicotine patch
- BEHAVIORAL Quit smoking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01056926 record still lists
NCT01056926 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo Patch is the first listed.
NCT01056926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01056926 about?
NCT01056926 is a clinical study titled "Neurobiology of Nicotine and Non-nicotine Components of Tobacco Addiction". In the present study the investigators will measure the effects of nicotine and non-nicotine factors on brain function during cognitive processes that are differentially sensitive to these factors. One process-continuous working memory (CWM)-is implemented via a network of frontal and parietal brain...
What is the current status of trial NCT01056926?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 147 participants. The study started on 2009-03. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01056926?
The interventions under investigation include: Placebo Patch (DRUG), Nicotine patch (DRUG), Quit smoking (BEHAVIORAL).
Who is sponsoring clinical trial NCT01056926?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01056926's enrollment target sits among peer trials
147 387th of 2000 higher than 1,610 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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