A single center, double blind, randomized, placebo controlled, two-treatments, two-period crossover study conducted in adult smokers.
The main objective of this study is to use blood oxygen level-dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) in abstinent smokers to directly evaluate the effect of the 4 milligrams (mg) nicotine lozenge on brain activation associated with visual attention. The experimental task featured 3 conditions: 1. a highly demanding cognitive/attention task, 2. a simple cognitive/attention task, and 3. simply look at a '+' symbol. During the experiment these conditions are each presented a number of times in an alternating manner while acquiring images.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
23
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Rapid Visual Information Processing (RVIP) Task
In RVIP task, participant responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participant responded to single occurrences of the number "0". BOLD fMRI signals evaluated different brain regions of interest (ROI) during RVIP task. Brain ROIs identified were right and left anterior insula, anterior putamen, parietal cortex, premotor cortex, visual cortex, dorsal anterior cingulate cortex, substantia nigra and thalamus.
Time frame: Approximately 2 hours post dose administration
Mean Response Time for Correct Responses During RVIP Task
During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participants responded to single occurrences of the number "0". Mean response time for correct responses was determined.
Time frame: Approximately 2 hours post dose administration
Mean Percentage of Correct Responses During RVIP Task
Percentage of correct responses during RVIP task was determined
Time frame: Approximately 2 hours post dose administration
Percent Mean Change in BOLD Scores During Divided Attention (DIA) Task
BOLD fMRI signals evaluated different brain ROIs during DIA task which comprised of three conditions: i) Sustained visual attention wherein participant responded to letter "s" every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number "8" each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of "s" (visual) and "8" (auditory) simultaneously. Brain ROIs were right and left parietal cortex, visual cortex, superior occipital cortex and right premotor cortex.
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Time frame: Approximately 2 hours post dose admininstration
Mean Response Time for Correct Responses During DIA Task
DIA task comprised of three conditions: i) Sustained visual attention wherein participant responded to letter "s" every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number "8" each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of "s" (visual) and "8" (auditory) simultaneously. Mean response time for correct responses was determined.
Time frame: Approximately 2 hours post dose administration
Mean Percentage of Correct Responses During DIA Task
Mean percentage of correct responses during DIA task was determined.
Time frame: Approximately 2 hours post dose administration