Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence

NCT00672256 | Completed Results

• 3 other identifiers: Pro00011917DA0172619270
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking

Keywords

Smoking; fMRI

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  12.5 minutes of fMRI scanning following smoking as usual

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

  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.

  12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

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

  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.

  12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

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

  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.

  12.5 minutes of fMRI scanning following smoking as usual

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:

• 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.

You may not qualify if:

• 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

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

Related Links

• Related Info

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Joseph McClernon
• Organization: Duke University Medical Center

mccle011@mc.duke.edu

919-668-3987

Study Officials

• Francis J McClernon, Ph.D

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: May 4, 2008
• First Posted: May 6, 2008
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 23, 2014
• Results First Posted: February 15, 2013

Record last verified: 2013-03

Locations

US (1)