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NCT01136642 · ClinicalTrials.gov registry record · Phase 1
Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01136642: Completed Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT01136642 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136642, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
Background: * Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Understanding the conditions under which nicotine improves attention and cognitive processing may provide more useful information for this research. * The ability to pay attention and filter relevant from irrelevant stimuli is central to all aspects of information-processing. Top-down and bottom-up attentional processes illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up processing is an unconscious response to sensory input; for instance, when the eyes automatically focus on a prominent image in a picture. Top-down processing is a conscious response to drive attention toward specific stimuli; for instance, when a person is asked to focus on a less immediately noticeable image in a picture. Researchers are interested in determining whether nicotine improves cognitive performance by acting on top-down or bottom-up attentional mechanisms. Objectives: \- To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers. Eligibility: \- Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55 years of age. Design: * This study will involve one training session and four experimental sessions. * During the training session, participants will receive a sample dose of the nicotine nasal spray used in the study to determine if they can tolerate the effects. * For each experimental session, participants will receive one dose of nicotine nasal spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate monitoring, performance of an attentional test, and questionnaires to rate participants perception of nicotine effectiveness. Participants may receive different doses at different ses
Interventions
- DRUG Nicotrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-01-21 |
| Est. Completion | 2012-11-13 |
| Phase | Phase 1 |
What the finished NCT01136642 record still lists
NCT01136642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which Nicotrol is the first listed.
NCT01136642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136642 about?
NCT01136642 is a clinical study titled "Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray". Background: * Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Understanding the conditions under whi...
What is the current status of trial NCT01136642?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2010-01-21. Estimated completion is 2012-11-13.
What interventions are being tested in trial NCT01136642?
The interventions under investigation include: Nicotrol (DRUG).
Who is sponsoring clinical trial NCT01136642?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01136642's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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