SmokingSmokeAtt02NCT00672256
Neuroimaging Decision Making and Response Inhibition During Smoking 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 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… 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
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 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
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
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 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.
Read the detailed description
Participants will learn and practice a Go/No-Go reaction time task (Garavan, Hester, Murphy, Fassbender, \& Kelly, 2006) that measures inhibitory and excitatory aspects of behavioral control. During the task subjects are presented with an alternating series of Xs and Ys in the center of the screen and must press a button every time they see a Go trial (the letter 'Y' or the letter 'X') while inhibiting a response when they are presented with a No-Go trial (any interruption of the X Y alternating stream, e.g., X Y Y).
- Conditions
- Smoking
- Being tested
- Smoking Abstinence
- Keywords
- Smoking, fMRI
- 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12.5 minutes of fMRI scanning following smoking as usual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionMar 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
- 62 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672256
- Sponsor's protocol ID
- Pro00011917
- Other IDs
- DA017261, 9270
- Acronym
- SmokeAtt02
- Status last verified
- Mar 2013
- First submitted
- 4 May 2008
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence
- ClinicalTrials.gov ID
- NCT00672256
- Acronym / sponsor ID
- SmokeAtt02 / Pro00011917
- Conditions
- Smoking
- Keywords
- Smoking, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Posted 15 Feb 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 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.
Detailed description
Participants will learn and practice a Go/No-Go reaction time task (Garavan, Hester, Murphy, Fassbender, \& Kelly, 2006) that measures inhibitory and excitatory aspects of behavioral control. During the task subjects are presented with an alternating series of Xs and Ys in the center of the screen and must press a button every time they see a Go trial (the letter 'Y' or the letter 'X') while inhibiting a response when they are presented with a No-Go trial (any interruption of the X Y alternating stream, e.g., X Y Y).
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 (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
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
Time frame: 12.5 minutes of fMRI scanning following smoking as usual
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.
Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Abstinent Day
Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
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.
Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Abstinent Day
Time frame: 12.5 minutes of fMRI scanning following 24 hrs smoking abstinence
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.
Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Satiated Day
Time frame: 12.5 minutes of fMRI scanning following smoking as usual
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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 University
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 9 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 23 Jul 2014. 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 15 Feb 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?
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 (time frame: 12.5 minutes of fMRI scanning following smoking as usual). The study lists 4 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 23 Jul 2014.