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

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT01136642

Collaborator

(none)

Enrollment

Location

33.7

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Addiction Nicotine Dependence	Drug: Nicotrol	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jan 21, 2010

Actual Study Completion Date :

Nov 13, 2012

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Vital signs, ratings of mood and drug effect. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

18-55 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

EXCLUSION CRITERIA:

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)