Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence (SmokeAtt02)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00672256
First received: May 4, 2008
Last updated: July 14, 2014
Last verified: March 2013
  Purpose

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.


Condition Intervention
Smoking
Behavioral: Smoking Abstinence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 62
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smokers not interested in quitting smoking
Smokers were scanned 24 hours after quitting smoking, and scanned after smoking as usual.
Behavioral: Smoking Abstinence
Smokers were scanned after having quitting smoking for 24 hours, and scanned after smoking as usual.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00672256

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Francis J McClernon, Ph.D Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00672256     History of Changes
Other Study ID Numbers: Pro00011917, DA017261, 9270
Study First Received: May 4, 2008
Results First Received: March 30, 2009
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Smoking
fMRI

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 22, 2014