Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray
Condition: Drug Addiction; Nicotine Dependence
MeSH terms: Tobacco Use Disorder; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

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 sessions, and will not be told which dose they will receive at any given
           point.
    

Detailed description: 
      Objective:

      The objective is to investigate the dose-response effect of nicotine on the top-down and
      bottom-up mechanisms of attention in cigarette smokers.

      Study population:

      Male and nonpregnant-female smokers 18 to 55 years of age.

      Design:

      This study is a double-blind, placebo controlled trial of nicotine or placebo nasal sprays.
      Participants have five visits: a training session and four experimental sessions. Each
      participant receives a test dose of the nasal spray immediately following the training
      session to ascertain tolerability and become familiarized with the effect of the spray. One
      dose (0, 1.0, 2.0 or 3.0 mg) of nicotine nasal spray is administered at the beginning of each
      experimental session followed by the test battery.

      Outcome Measures:

      Outcome measures are vital signs, ratings of mood and drug effect, and performance (accuracy,
      response time) on a test of selective attention.
    

Intervention name(s): Nicotrol
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Other
Keywords: Nicotine; Nicotine Nasal Spray; Attention; Smoking