N/A N=80 Randomized Basic Science

Neuroimaging Attentional Impairment During Abstinence

Smoking

Bottom Line

View on ClinicalTrials.gov: NCT00692406 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Satiated Day — -0.0023 percentage of signal change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Smoking Abstinence (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Satiated Day	-0.0023	<0.001 sig
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Abstinent Day	0.1167	<0.001 sig
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Satiated Day	-0.0253	<0.001 sig
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Abstinent Day	0.1432	<0.001 sig
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day	-0.0489	<0.001 sig
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day	0.0096	<0.001 sig
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day	-0.0372	<0.001 sig
PRIMARY Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day	0.1210	<0.001 sig

Summary

The broad objective of this proposal is to identify functional neuroanatomical correlates of impairments in sustained attention during smoking abstinence. We will measure changes in performance and regional blood oxygenation levels using fMRI while smokers and non-smokers complete a task designed to assess sustained attention-or the continuous monitoring of stimuli. Our primary hypothesis is that smoking abstinence will result in impaired sustained attention accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in regions associated with sustained attention including right fronto-parietal cortex, thalamus and reticular activation system. Abstinence may also result in performance-related increases in activation in brain regions associated with effortful processing including the anterior cingulate cortex. We also hypothesize that smokers during the satiated state will exhibit brain activity more similar to that of non-smokers. In addition to task related brain responses, we will also measure changes in absolute regional cerebral blood flow (rCBF) and hypothesize that abstinence will result in significant decreases in regions associated with arousal (e.g., reticular activation system); information processing (e.g., thalamus); and emotional regulation (e.g., anterior cingulate cortex, prefrontal cortex).

Eligibility Criteria

Inclusion Criteria

smoked an average of 10 cigarettes per day for two years
a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine
have an expired air carbon monoxide reading of at least 10 ppm.
be in general good health
Participants with controlled medical conditions (e.g., hypertension) will be considered if treatment is not thought to interfere with fMRI measures or potentially ameliorate smoking withdrawal symptoms

Exclusion Criteria

Individuals with a major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant),
uncomfortable (e.g., chronic pain),
confound results (e.g., psychiatric condition)
suffering from claustrophobia; abnormally afraid of closed-in places will be excluded from participation,
Current alcohol or drug abuse,
smokeless tobacco use, or use of nicotine replacement therapy or other smoking cessation treatment will also be a basis for exclusion and evaluated via a urine test.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00692406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.