Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
Condition: Substance Related Disorder; Nicotine Dependence
MeSH terms: Tobacco Use Disorder; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Objective: The primary objective of this study is to investigate the dose-related effects of
      nicotine on various elements of attention in smokers and nonsmokers. Because no published
      study, to our knowledge, has reported the effects of nicotine on the ANT and ABT, we will
      include the CPT, a task shown to be sensitive to nicotine, as a positive control. A secondary
      aim is to compare the subjective and physiological effects of nicotine between smokers and
      nonsmokers.

      Study Population: 50 smokers for a total of 30 completers (15 women, 15 men) and up to 50
      nonsmokers for a total of 30 completers (15 women, 15 men).

      Design: Placebo-controlled, between-groups comparison of smokers and nonsmokers. Participants
      will attend three experiemental sessions; a single dose of nicotine nasal spray (0, 0.5, or
      1.5 mg) will be administered at each session.

      Outcome Measures: Primary outcome measures will be accuracy and/or response time on the three
      attention tests, ANT, CPT, and ABT. Secondary outcome measures include responses to the
      PANAS, VAS items, and vital signs (heart rate and blood pressure). Participant demographics
      and smoking history will be reported using descriptive statistics.
    

Intervention name(s): Nicotine
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Primary purpose: Treatment
Keywords: Nasal Spray; Attention Network Test; Continuous Performance Test; Attentional Blink Test