Trial Outcomes & Findings for Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence (NCT NCT00672256)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

12.5 minutes of fMRI scanning following smoking as usual

Results posted on

2014-07-23

Participant Flow

community recruitment completed recruitment March 2009

enrolled participants would be excluded if they were unable to meet study requirements, or had scheduling issues.

Participant milestones

Participant milestones
Measure	Smokers Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
Overall Study STARTED	62
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Reasons for withdrawal
Measure	Smokers Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
Overall Study PI dropped, bad data	44

Baseline Characteristics

Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smokers n=62 Participants Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.5 years STANDARD_DEVIATION 10.03 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following smoking as usual

Population: 18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.

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.

Outcome measures

Outcome measures
Measure	Smokers n=15 Participants Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
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 Standard Deviation 0.099

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

Population: 18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.

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.

Outcome measures

Outcome measures
Measure	Smokers n=15 Participants Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
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 percentage of signal change Standard Deviation 0.141

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence

Population: 18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.

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.

Outcome measures

Outcome measures
Measure	Smokers n=15 Participants Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
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 percentage of signal change Standard Deviation 0.123

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following smoking as usual

Population: 18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.

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.

Outcome measures

Outcome measures
Measure	Smokers n=15 Participants Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
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 percentage of signal change Standard Deviation 0.170

Adverse Events

Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph McClernon

Duke University Medical Center

Phone: 919-668-3987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place