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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 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 43 participants.

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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

FieldValue
Enrollment Target 43 participants
Start Date 2010-01-21
Est. Completion 2012-11-13
Phase Phase 1

What the Registry Record Tells You About NCT01136642

The ClinicalTrials.gov registry entry for NCT01136642 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Nicotrol is the first listed.

NCT01136642 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.