Trial Outcomes & Findings for Neuroimaging Attentional Impairment During Abstinence (NCT NCT00692406)

NCT ID: NCT00692406

Last Updated: 2013-03-28

Results Overview

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following smoking as usual. Differences in brain activations were considered significant at p\<.001.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 12.5 minutes of fMRI scanning following smoking as usual
• Results posted on: 2013-03-28

Participant Flow

Recruitment began on 6/23/05. We advertised in local newpapers, with flyers around Durham, and posting on dukeheatlh.org and dukesmoking.com. We recruited for this study until 11/08

If participants were excluded from the trial after enrollment it was due to inability to perform tasks, no shows to sessions, and or unsafe circumstances for the MRI sessions. Otherwise persons were lost to contact and/or decided to not participate anymore.

Participant milestones

Measure	Smokers Not Interested in Quitting Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
Overall Study STARTED	80
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Measure	Smokers Not Interested in Quitting Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
Overall Study PI dropped, bad data	57

Baseline Characteristics

Neuroimaging Attentional Impairment During Abstinence

Baseline characteristics by cohort

Measure	Smokers Not Interested in Quitting n=80 Participants Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	31.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment United States	80 participants 0 • n=5 Participants

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following smoking as usual

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following smoking as usual. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Satiated Day	-0.0023 percentage of signal change Standard Deviation 0.15467

PRIMARY outcome

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

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Abstinent Day	0.1167 percentage of signal change Standard Deviation 0.19161

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following smoking as usual

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following smoking as usual. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Satiated Day	-0.0253 percentage of signal change Standard Deviation 0.22800

PRIMARY outcome

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

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Abstinent Day	0.1432 percentage of signal change Standard Deviation 0.29593

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following smoking as usual

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in AnG following smoking as usual. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day	-0.0489 percentage of signal change Standard Deviation 0.08334

PRIMARY outcome

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

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in AnG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day	0.0096 percentage of signal change Standard Deviation 0.15990

PRIMARY outcome

Timeframe: 12.5 minutes of fMRI scanning following smoking as usual

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in Cun following smoking as usual. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day	-0.0372 percentage of signal change Standard Deviation 0.17545

PRIMARY outcome

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

Population: the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.

Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in Cun following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.

Outcome measures

Measure	Smokers Not Interested in Quitting n=19 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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day	0.1210 percentage of signal change Standard Deviation 0.20106

Adverse Events

Smokers Not Interested in Quitting

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

Dr. F. Joseph McClernon

DukeUMC

Phone: 919-668-3987

Email: mccle011@mc.duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place