SmokingSmokeAtt01NCT00692406
Neuroimaging Attentional Impairment During Abstinence
A study testing Smoking Abstinence in people with Smoking, run by Duke University at 1 site in United States.
Trial summary
The broad objective of this proposal is to identify functional neuroanatomical correlates of impairments in sustained attention during smoking abstinence. We will measure changes in performance and regional blood oxygenation levels using fMRI while smokers and non-smokers complete a task designed to assess sustained… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Smoking Abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- smoked an average of 10 cigarettes per day for two years
- 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.
- be in general good health
- Participants with controlled medical conditions (e.g., hypertension) will be considered if treatment is not thought to interfere with fMRI measures or potentially ameliorate smoking withdrawal symptoms
Who cannot join
- Individuals with a major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant),
- uncomfortable (e.g., chronic pain),
- confound results (e.g., psychiatric condition)
- suffering from claustrophobia; abnormally afraid of closed-in places will be excluded from participation,
- Current alcohol or drug abuse,
- smokeless tobacco use, or use of nicotine replacement therapy or other smoking cessation treatment will also be a basis for exclusion and evaluated via a urine test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
The broad objective of this proposal is to identify functional neuroanatomical correlates of impairments in sustained attention during smoking abstinence. We will measure changes in performance and regional blood oxygenation levels using fMRI while smokers and non-smokers complete a task designed to assess sustained attention-or the continuous monitoring of stimuli.
Our primary hypothesis is that smoking abstinence will result in impaired sustained attention accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in regions associated with sustained attention including right fronto-parietal cortex, thalamus and reticular activation system. Abstinence may also result in performance-related increases in activation in brain regions associated with effortful processing including the anterior cingulate cortex. We also hypothesize that smokers during the satiated state will exhibit brain activity more similar to that of non-smokers.
In addition to task related brain responses, we will also measure changes in absolute regional cerebral blood flow (rCBF) and hypothesize that abstinence will result in significant decreases in regions associated with arousal (e.g., reticular activation system); information processing (e.g., thalamus); and emotional regulation (e.g., anterior cingulate cortex, prefrontal cortex).
Read the detailed description
Following an extended training period in which performance will become stable, smokers will be tested in the 4 Tesla MRI scanner (GE LX NVi system) 24 hours after quitting smoking, and tested satiated, while non-smokers will be tested in the scanner once under normal conditions. This design will provide an assessment of how tobacco abstinence alters information processing.
Included smoker participants will smoke at least 10 cigarettes per day of a brand delivering at least 0.5 mg nicotine (by FTC method) for at least two years and have afternoon end tidal carbon monoxide (CO) concentrations of at least 10 ppm (confirming they are inhalers). Inclusion criteria for non-smoker participants is that they should have smoked less than 50 cigarettes in their lifetime, have not smoked or used any nicotine products during the last 6 months, and have afternoon end tidal CO of less than or equal to 5 ppm. In order to reduce variability and ensure comparable stimulus exposure, participants will be required to be right-handed, and have at least 20-30 corrected vision.
During a screening session, all aspects of the study will be described to subjects and informed consent will be acquired. Breath and saliva samples will be collected in order to verify smoking status; and paper-and-pencil measures of smoking history, nicotine dependence, and mood will be collected. Each subject will also complete a Brain Imaging and Analysis Center (BIAC) approved fMRI subject screening form. For females of child bearing potential, a blood sample will be taken for pregnancy testing. For all participants, a urine sample will be taken for illicit drug testing. Finally, each subject will be escorted to the hospital where they will view and be placed in a mock fMRI scanner for a short time in order to increase familiarity with study procedures. Subjects who meet all selection criteria will be scheduled for the remainder of sessions.
Participants will learn and practice a sustained attention task. The planned sustained attention task, called the rapid visual information processing task (RVIP) requires participants to identify series of three odd or three even numbers among a series of numbers presented one at a time on a computer monitor. A control task in which participants press a button when they see a '0' will also be practiced. Total task time is 15 minutes (practice version) and each participant will be required to complete as many as 8 practice versions or until 50% accuracy is achieved on two consecutive attempts. Training may require 2-8 visits but will not exceed 2 hours and 40 minutes in total duration. One practice version of the task will be conducted in the mock fMRI scanner.
Following the training period, smoker participants will complete two fMRI scans and non-smokers will complete one fMRI scan in which they will complete 1) undergo a five minute resting state BOLD scan, 2) two 12.5 minute versions of the RVIP and 3) a 12.5-minute 'cue-viewing' task in which they view pictures of people smoking. For the 'satiated' sessions, smoker participants will be instructed to smoke as usual before and after the session. For the 'abstinent' session, smoker participants will be required to quit smoking for 24 hours prior to the scan and 24 hours following the scan. Quitting will be verified using CO and salivary cotinine and nicotine levels collected at the time of the scan and a short session 24 hours after the scan. All smoker participants will be given information about quitting smoking for 48 hours and we will answer questions about quitting smoking. The order of the sessions-satiated first vs. abstinent first-will be randomly assigned.
One week after their second scan, participants will attend a 30-minute office visit in which they will complete questionnaires and the RVIP task.
- Conditions
- Smoking
- Being tested
- Smoking Abstinence
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking AbstinenceBehavioural
Smokers were scanned after having quitting smoking for 24 hours, and scanned after smoking as usual.
| Study group | Role | What they receive |
|---|---|---|
| Smokers not interested in quitting smoking | Experimental | Smokers were scanned 24 hours after quitting smoking, and scanned after smoking as usual. Receives: Behavioral: Smoking Abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 12.5 minutes of fMRI scanning following smoking as usual
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
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.
Measured: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
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
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.
Measured: 12.5 minutes of fMRI scanning following smoking as usual
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
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.
Measured: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day
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.
Measured: 12.5 minutes of fMRI scanning following smoking as usual
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day
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.
Measured: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day
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.
Measured: 12.5 minutes of fMRI scanning following smoking as usual
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day
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.
Measured: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Francis J McClernon, Ph.D, Principal investigator, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692406
- Sponsor's protocol ID
- Pro00007082
- Acronym
- SmokeAtt01
- Status last verified
- Feb 2013
- First submitted
- 3 Jun 2008
- Last updated
- 28 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Attentional Impairment During Abstinence
- ClinicalTrials.gov ID
- NCT00692406
- Acronym / sponsor ID
- SmokeAtt01 / Pro00007082
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 28 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The broad objective of this proposal is to identify functional neuroanatomical correlates of impairments in sustained attention during smoking abstinence. We will measure changes in performance and regional blood oxygenation levels using fMRI while smokers and non-smokers complete a task designed to assess sustained attention-or the continuous monitoring of stimuli.
Our primary hypothesis is that smoking abstinence will result in impaired sustained attention accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in regions associated with sustained attention including right fronto-parietal cortex, thalamus and reticular activation system. Abstinence may also result in performance-related increases in activation in brain regions associated with effortful processing including the anterior cingulate cortex. We also hypothesize that smokers during the satiated state will exhibit brain activity more similar to that of non-smokers.
In addition to task related brain responses, we will also measure changes in absolute regional cerebral blood flow (rCBF) and hypothesize that abstinence will result in significant decreases in regions associated with arousal (e.g., reticular activation system); information processing (e.g., thalamus); and emotional regulation (e.g., anterior cingulate cortex, prefrontal cortex).
Detailed description
Following an extended training period in which performance will become stable, smokers will be tested in the 4 Tesla MRI scanner (GE LX NVi system) 24 hours after quitting smoking, and tested satiated, while non-smokers will be tested in the scanner once under normal conditions. This design will provide an assessment of how tobacco abstinence alters information processing.
Included smoker participants will smoke at least 10 cigarettes per day of a brand delivering at least 0.5 mg nicotine (by FTC method) for at least two years and have afternoon end tidal carbon monoxide (CO) concentrations of at least 10 ppm (confirming they are inhalers). Inclusion criteria for non-smoker participants is that they should have smoked less than 50 cigarettes in their lifetime, have not smoked or used any nicotine products during the last 6 months, and have afternoon end tidal CO of less than or equal to 5 ppm. In order to reduce variability and ensure comparable stimulus exposure, participants will be required to be right-handed, and have at least 20-30 corrected vision.
During a screening session, all aspects of the study will be described to subjects and informed consent will be acquired. Breath and saliva samples will be collected in order to verify smoking status; and paper-and-pencil measures of smoking history, nicotine dependence, and mood will be collected. Each subject will also complete a Brain Imaging and Analysis Center (BIAC) approved fMRI subject screening form. For females of child bearing potential, a blood sample will be taken for pregnancy testing. For all participants, a urine sample will be taken for illicit drug testing. Finally, each subject will be escorted to the hospital where they will view and be placed in a mock fMRI scanner for a short time in order to increase familiarity with study procedures. Subjects who meet all selection criteria will be scheduled for the remainder of sessions.
Participants will learn and practice a sustained attention task. The planned sustained attention task, called the rapid visual information processing task (RVIP) requires participants to identify series of three odd or three even numbers among a series of numbers presented one at a time on a computer monitor. A control task in which participants press a button when they see a '0' will also be practiced. Total task time is 15 minutes (practice version) and each participant will be required to complete as many as 8 practice versions or until 50% accuracy is achieved on two consecutive attempts. Training may require 2-8 visits but will not exceed 2 hours and 40 minutes in total duration. One practice version of the task will be conducted in the mock fMRI scanner.
Following the training period, smoker participants will complete two fMRI scans and non-smokers will complete one fMRI scan in which they will complete 1) undergo a five minute resting state BOLD scan, 2) two 12.5 minute versions of the RVIP and 3) a 12.5-minute 'cue-viewing' task in which they view pictures of people smoking. For the 'satiated' sessions, smoker participants will be instructed to smoke as usual before and after the session. For the 'abstinent' session, smoker participants will be required to quit smoking for 24 hours prior to the scan and 24 hours following the scan. Quitting will be verified using CO and salivary cotinine and nicotine levels collected at the time of the scan and a short session 24 hours after the scan. All smoker participants will be given information about quitting smoking for 48 hours and we will answer questions about quitting smoking. The order of the sessions-satiated first vs. abstinent first-will be randomly assigned.
One week after their second scan, participants will attend a 30-minute office visit in which they will complete questionnaires and the RVIP task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers not interested in quitting smoking | Experimental | Behavioral: Smoking AbstinenceSmokers were scanned 24 hours after quitting smoking, and scanned after smoking as usual. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- smoked an average of 10 cigarettes per day for two years
- 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.
- be in general good health
- Participants with controlled medical conditions (e.g., hypertension) will be considered if treatment is not thought to interfere with fMRI measures or potentially ameliorate smoking withdrawal symptoms
Key exclusion criteria (6 listed)
- Individuals with a major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant),
- uncomfortable (e.g., chronic pain),
- confound results (e.g., psychiatric condition)
- suffering from claustrophobia; abnormally afraid of closed-in places will be excluded from participation,
- Current alcohol or drug abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking AbstinenceSmokers were scanned after having quitting smoking for 24 hours, and scanned after smoking as usual. | Behavioural | Smokers not interested in quitting smoking |
Primary outcome
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
Time frame: 12.5 minutes of fMRI scanning following smoking as usual
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.
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
Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
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.
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
Time frame: 12.5 minutes of fMRI scanning following smoking as usual
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.
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
Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day
Time frame: 12.5 minutes of fMRI scanning following smoking as usual
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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day
Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day
Time frame: 12.5 minutes of fMRI scanning following smoking as usual
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.
Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day
Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis J McClernon, Ph.D principal investigator
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Abstinence in people with Smoking, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12.5 minutes of fMRI scanning following smoking as usual). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.