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Completed

NCT Number: NCT00672256

Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence

The broad objective of this proposal is to identify functional neuroanatomical correlates of impairments in response inhibition during smoking abstinence. We will measure changes in performance and regional blood oxygenation levels using functional magnetic resonance imaging (fMRI)while smokers complete tasks designed to assess decision making and response inhibition.

Our primary hypothesis is that smoking abstinence will result in impaired response inhibition accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in brain regions associated with these cognitive processes including frontal cortex and the ventral striatum. Abstinence may also result in performance-related increases in activation in brain regions associated with effortful processing including the anterior cingulate cortex in effort to compensate for deficits in other regions.

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Key information

Conditions

Smoking Behavior

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

Participants will learn and practice a Go/No-Go reaction time task (Garavan, Hester, Murphy, Fassbender, & Kelly, 2006) that measures inhibitory and excitatory aspects of behavioral control. During the task subjects are presented with an alternating series of Xs and Ys in the center of the screen and must press a button every time they see a Go trial (the letter 'Y' or the letter 'X') while inhibiting a response when they are presented with a No-Go trial (any interruption of the X Y alternating stream, e.g., X Y Y).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Smoker subjects must have

  • smoked an average of 10 cigarettes per day for two continuous years of 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.
  • must be in general good health

Non-smoker subjects must have

  • smoked less than 50 cigarettes in their lifetime
  • have not smoked in the last six months
  • have an expired air carbon monoxide reading of less than or equal to 5 ppm.
  • must be in general good health.

Exclusion criteria

  • major medical condition
  • anything that would make participation unsafe (e.g., have pacemaker or other metallic implant) or uncomfortable (e.g., chronic pain)
  • psychiatric condition
  • suffering from claustrophobia
  • current alcohol or drug abuse
  • smokeless tobacco use, or use of nicotine replacement therapy or other smoking cessation treatment

Treatment and study plan

smoking abstinence

Behavioral

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

Primary outcomes

  1. Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Satiated Day

    Time frame: 12.5 minutes of fMRI scanning following smoking as usual

    Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.

    Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial.

  2. Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Abstinent Day

    Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

    Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.

    Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial.

  3. Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Abstinent Day

    Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

    Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.

    Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial.

  4. Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Satiated Day

    Time frame: 12.5 minutes of fMRI scanning following smoking as usual

    Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.

    Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: SmokeAtt02

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 6, 2008
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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