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

NCT01136642 | Completed Phase 1

• 2 other identifiers: 99991045910-DA-N459
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Addiction; Nicotine Dependence

Keywords

Nicotine; Nicotine Nasal Spray; Attention; Smoking

Outcome Measures

Primary Outcomes (1)

• Performance (accuracy response time) on a test of selective attention.

Secondary Outcomes (1)

• Vital signs, ratings of mood and drug effect.

Interventions

Nicotrol DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• year old male and female cigarette smokers
• smoke a minimum of 10 cigarettes per day for at least 1 year
• Drug Use Survey
• estimated IQ score greater than or equal to 85
• Weschsler Abbreviated Scale of Intelligence (WASI; raw vocabulary cutoff 49)
• urine cotinine concentration greater than or equal 100 ng/ml
• NicAlert reading greater than or equal to 3

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)

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

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

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Tobacco Use Disorder; Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Carol Myers, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: January 21, 2010
• Study Completion: November 13, 2012
• Last Updated: December 16, 2019

Record last verified: 2012-11-13

Locations

US (1)