N/A
N=62
Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT00672256 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: 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 — 0.039 percentage of signal change — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Smoking Abstinence (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.039 | <0.05 sig |
| PRIMARY Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Abstinent Day |
0.104 | <0.05 sig |
| PRIMARY Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Abstinent Day |
0.173 | <0.05 sig |
| PRIMARY Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Satiated Day |
0.169 | <0.05 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00672256). 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.