Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray

Completed · Phase 1

Conditions studied: Drug Addiction, Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT01136642

Run by

National Institute on Drug Abuse (NIDA)

People needed

43

Starts

2010-01-21

Expected to finish

2012-11-13

Last updated by the study team

2019-12-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• definite plan to quit smoking in next 30 days
• consumption of more than 15 alcoholic drinks per week during the past month
• use of any illicit drugs more than twice per week during the past month
• -Drug Use Survey (items 2-4)
• pregnant or nursing
• -Urine pregnancy test
• HIV positive
• -Oral HIV test
• untreated cardiovascular or pulmonary disease
• use of nicotine replacement products, bupropion or varenicline, in the past 3 months if specifically used to stop smoking
• Past history of schizophrenia or bipolar disorder.
• Current Major Depression Disorder, Diagnosis or treatment for Major Depressive Disorder in past 12 months. (H\&P)
• Evidence of current ADHD by current diagnosis or medication or score on Adult Symptom Rating Scale; (> 16 on pt A or B must be evaluated by a counselor)
• SCL-90 > 65 (must be evaluated by a counselor)
• Beck Depression Inventory-II score greater than or equal to 14 (must be evaluated by a counselor)
• vital signs (must be outside these parameters on more than two occasions separated by at least one day):
• systolic blood pressure: minimum 95, maximum 160 mm Hg
• diastolic blood pressure: minimum 40, maximum 95 mm Hg
• pulse: minimum 50, maximum 105 bpm
• respirations: minimum 8, maximum 24 breaths per minute
• nasal passages: no pathology that would preclude administration of nasal spray
• under the influence of a drug or alcohol at experimental sessions

Where it is running

• National Institute on Drug Abuse, Biomedical Research Center (BRC) — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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