Neuroimaging Attentional Impairment During Abstinence

NCT00692406 | Completed Results

• 1 other identifier: Pro00007082
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Smoking

Outcome Measures

Primary Outcomes (8)

• 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

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following smoking as usual. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following smoking as usual

• 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

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following not smoking for 24 hours. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

• 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

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following smoking as usual. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following smoking as usual

• 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

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following not smoking for 24 hours. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

• Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in AnG following smoking as usual. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following smoking as usual

• Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in AnG following not smoking for 24 hours. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

• Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in Cun following smoking as usual. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following smoking as usual

• Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day

  Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in Cun following not smoking for 24 hours. Differences in brain activations were considered significant at p\<.001.

  12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

Study Arms (1)

Smokers not interested in quitting smoking

EXPERIMENTAL

Smokers were scanned 24 hours after quitting smoking, and scanned after smoking as usual.

Behavioral: Smoking Abstinence

Interventions

Smoking Abstinence BEHAVIORAL

Smokers were scanned after having quitting smoking for 24 hours, and scanned after smoking as usual.

Smokers not interested in quitting smoking

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. F. Joseph McClernon
• Organization: DukeUMC

mccle011@mc.duke.edu

919-668-3987

Study Officials

• Francis J McClernon, Ph.D

  Duke UMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 6, 2008
• Study Start: June 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 28, 2013
• Results First Posted: March 28, 2013

Record last verified: 2013-02

Locations

US (1)