SmokingSmokeAtt04NCT01632384
The Effects of Smoking Withdrawal On Resting State Functional Connectivity
A study testing Abstain from smoking for 24 hours in people with Smoking, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to see how the brain differs between smoking regularly and after not smoking for 24 hours. The investigators will be using an MRI machine to get the information from adult smokers and non-smokers while they lie in the scanner with their eyes closed. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Abstain from smoking for 24 hours
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right handed
- Drug free
- No known health problems
- Currently not taking any medication
- Uninterested in quitting smoking long term
Who cannot join
- Left handed/ambidextrous
- Currently taking medication
- Interested in quitting long term
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Health Behavior Neuroscience Research Program
Durham, North Carolina, 27705
About this study
Official title: The Effects of Smoking Withdrawal on Resting State Functional Connectivity
The purpose of this study is to see how the brain differs between smoking regularly and after not smoking for 24 hours. The investigators will be using an MRI machine to get the information from adult smokers and non-smokers while they lie in the scanner with their eyes closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after smoking. It is our hypothesis that brain activity will be altered after not smoking for 24 hours.
Read the detailed description
The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in brain functional connectivity during smoking abstinence. The investigators will measure changes in regional blood oxygenation levels using fMRI while adult smokers and non-smokers lie in the scanner with their eyes closed. Smokers will be scanned when they are abstinent from smoking for 24 hrs and shortly after smoking. Our primary hypothesis is that smoking abstinence will alter resting state brain activity (or resting state functional connectivity; RSFC) across widely distributed neural networks and that high-resolution fMRI will help in resolving the exact nature of such changes. Data will be analyzed using methods developed in our laboratory and applied to other resting state datasets. All of the procedures used in the study are well validated and introduce only minor risk to participants (e.g. blood draw; MRI).
- Conditions
- Smoking
- Being tested
- Abstain from smoking for 24 hours
- Keywords
- Smoker, Non-Smoker, Healthy, Drug free, MRI
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstain from smoking for 24 hoursBehavioural
Compare smoking satiation to 24 hour smoking abstinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-oxygen-level-dependent (BOLD) signal
Smokers will be scanned after smoking to satiety. In order to be considered satiated, smokers will have to be regular smokers (smoking daily for at least 2 years).
Measured: following smoking cigarette 30 minutes prior to scan
Secondary outcomes (1)
Blood-oxygen-level-dependent (BOLD) signal
Smokers will be asked to stop smoking 24 hours prior to the scan without the aid of nicotine replacement therapies. They will resume smoking as usual 24 hours after the scan.
Measured: 24 hours abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: study close-out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Francis J McClernon, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632384
- Sponsor's protocol ID
- Pro00031550
- Other IDs
- R01DA023516
- Acronym
- SmokeAtt04
- Status last verified
- Jan 2013
- First submitted
- 20 Feb 2012
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Smoking Withdrawal on Resting State Functional Connectivity
- ClinicalTrials.gov ID
- NCT01632384
- Acronym / sponsor ID
- SmokeAtt04 / Pro00031550
- Conditions
- Smoking
- Keywords
- Smoker, Non-Smoker, Healthy, Drug free, MRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study close-out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how the brain differs between smoking regularly and after not smoking for 24 hours. The investigators will be using an MRI machine to get the information from adult smokers and non-smokers while they lie in the scanner with their eyes closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after smoking. It is our hypothesis that brain activity will be altered after not smoking for 24 hours.
Detailed description
The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in brain functional connectivity during smoking abstinence. The investigators will measure changes in regional blood oxygenation levels using fMRI while adult smokers and non-smokers lie in the scanner with their eyes closed. Smokers will be scanned when they are abstinent from smoking for 24 hrs and shortly after smoking. Our primary hypothesis is that smoking abstinence will alter resting state brain activity (or resting state functional connectivity; RSFC) across widely distributed neural networks and that high-resolution fMRI will help in resolving the exact nature of such changes. Data will be analyzed using methods developed in our laboratory and applied to other resting state datasets. All of the procedures used in the study are well validated and introduce only minor risk to participants (e.g. blood draw; MRI).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Right handed
- Drug free
- No known health problems
- Currently not taking any medication
- Uninterested in quitting smoking long term
Key exclusion criteria (3 listed)
- Left handed/ambidextrous
- Currently taking medication
- Interested in quitting long term
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 |
|---|---|---|
| Abstain from smoking for 24 hoursCompare smoking satiation to 24 hour smoking abstinence | Behavioural | – |
Primary outcome
Blood-oxygen-level-dependent (BOLD) signal
Time frame: following smoking cigarette 30 minutes prior to scan
Smokers will be scanned after smoking to satiety. In order to be considered satiated, smokers will have to be regular smokers (smoking daily for at least 2 years).
1 secondary outcome
Blood-oxygen-level-dependent (BOLD) signal
Time frame: 24 hours abstinence
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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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 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 Abstain from smoking for 24 hours 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 3 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: withdrawn, as of the sponsor's last update on 31 Jan 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood-oxygen-level-dependent (BOLD) signal (time frame: following smoking cigarette 30 minutes prior to scan). 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 31 Jan 2017.