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NCT01034020 · ClinicalTrials.gov registry record · Phase 1

Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers

A Phase 1 study of Nicotine Dependence and Substance Related Disorder, sponsored by National Institute on Drug Abuse (NIDA).

Completed
Registry status
Phase 1
Development phase
100
Enrollment target
1
Study location

NCT01034020 is a Phase 1 study of Nicotine Dependence and Substance Related Disorder that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 100 participants, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01034020, a Phase 1 study of Nicotine Dependence and Substance Related Disorder, has completed, sponsored by National Institute on Drug Abuse (NIDA).

COMPLETED
Registry status
Phase 1
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

Background: \- Many cigarette smokers claim that smoking helps them stay alert and improves their concentration, and have reported problems in attention and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain's ability to pay attention. Knowing which aspects of attention are affected by nicotine may help produce new medications and therapies to help people successfully stop smoking. Objectives: * To investigate the dose-related effects of nicotine on the ability to pay attention in smokers and nonsmokers. * To compare the effects of nicotine in smokers and nonsmokers. Eligibility: \- Individuals between 18 and 50 years of age who are either current smokers (at least 15 cigarettes per day on average for at least 2 years) or healthy, nonsmoking volunteers. Design: * The study will consist of one training session and three testing sessions. Each session will last about 2 hours. * The training session will introduce participants to the study tests and evaluate their tolerance of the two levels of nicotine nasal spray used in the study. Smokers will receive the higher dose of nicotine to introduce them to the effects of the spray. Nonsmokers will be given first the lower dose of the spray, followed by higher dose at least 30 minutes later. Nonsmoking participants who cannot tolerate the higher dose will not continue in the study. * At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine. * During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate mood, attention, and performance.

Interventions

  • DRUG Nicotine

Study Locations (1)

Maryland

  • National Institute on Drug Abuse, Biomedical Research Center (BRC) - Baltimore

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2006-02-14
Est. Completion 2009-11-03
Phase Phase 1

What the Registry Record Tells You About NCT01034020

The ClinicalTrials.gov registry entry for NCT01034020 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (46% lower). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Nicotine Dependence appearing as the primary indexed condition, and to 1 intervention - of which Nicotine is the first listed.

NCT01034020 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01034020 about?

NCT01034020 is a clinical study titled "Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers". Background: \- Many cigarette smokers claim that smoking helps them stay alert and improves their concentration, and have reported problems in attention and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans....

What is the current status of trial NCT01034020?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2006-02-14. Estimated completion is 2009-11-03.

What conditions does trial NCT01034020 study?

This clinical trial studies the following conditions: Nicotine Dependence, Substance Related Disorder.

What interventions are being tested in trial NCT01034020?

The interventions under investigation include: Nicotine (DRUG).

Who is sponsoring clinical trial NCT01034020?

This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01034020 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.