Nicotine DependenceRTSmokingNCT01411007
The Impact of Real-time Functional Magnetic Resonance Imaging (fMRI) Feedback on Response to Nicotine Cues
An observational study of Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to develop a technique to provide feedback of brain activity and to use this technique to reduce levels of craving in nicotine dependent smokers. The researchers will use a brain scan called functional magnetic resonance imaging (MRI). MRI uses magnets to take pictures of your brain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2016
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult nicotine dependant smokers and Healthy controls
Who may be able to join
- Age 18 - 60 right handed adults.
- General good health confirmed by history \& physical.
- Able to read and understand questionnaires and informed consent.
- Participants must have a negative urine drug screen (UDS) and pregnancy test prior to imaging sessions.
- Female participants will use a reliable method of birth control throughout the study.
- Additional Inclusion Criteria for non-smoking group:
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- 1. Has used tobacco products no more than on experimental basis (none in past year).
- Additional Inclusion Criteria for smoking group:
- Smokers must meet criteria for primary nicotine dependence confirmed by Fagerström Test for Nicotine Dependence (FTND) and smoking on average 10 cigarettes a day in the last 30 days prior to assessment.
- Smokers must be motivated to quit.
- Demonstrate subjective craving as measured by the Questionnaire of Smoking Urges (QSU)-B.
Who cannot join
- Meets the Diagnostic and Statistical Manual (DSM)-IV criterion for lifetime or current substance dependence except for nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- Use of other tobacco products.
- Current use of nicotine replacement therapy, bupropion, varenicline, or other smoking cessation treatment.
- Healthy volunteers must not have had more than experimental use of cigarettes.
- Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. The rationale for excluding them is that symptoms from these disorders may affect dependent variables and complicate interpretation of the data.
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- Current suicidal ideation with plan or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
- Clinically significant medical problems that would impair participation or limit ability to participate in scan.
- Sexually active females of child-bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including Driving Under the Influence (DUI) related offenses).
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Impact of Real-time fMRI Feedback on Response to Nicotine Cues
The purpose of this study is to develop a technique to provide feedback of brain activity and to use this technique to reduce levels of craving in nicotine dependent smokers. The researchers will use a brain scan called functional magnetic resonance imaging (MRI). MRI uses magnets to take pictures of your brain. Functional MRI measures brain blood flow that is related to brain activity. This measure of brain activity can be presented or "feedback" to volunteers.
Read the detailed description
There are three total visits for this study. Details of each visit are listed below.
Screening/Assessment Visit:
This evaluation will include interviews, questionnaires, computerized testing, urine drug screen, breath sample for carbon monoxide level and alcohol and physical examination. If accepted into this study, you will then be scheduled for a biofeedback and an imaging session. Both smokers and nonsmoking controls will go through the screening process.
Biofeedback Session:
You will be asked to participate in a biofeedback session scheduled for 60 minutes. You will be comfortably seated and a sensor to measure your temperature will be placed on a finger of your non-dominant hand. You will be asked to make changes in your skin temperature based on feedback from the monitoring system. Your responses to the biofeedback session will be compared to your responses to feedback in the scanner. Both smokers and nonsmoking controls will go through the biofeedback session.
Imaging Visit:
The imaging visit should last approximately 2 hours. You will also be asked to refrain from using alcohol and any street drugs for 24 hours and from using any marijuana for 3 days prior to the visit. If you smoke, you will be asked not to smoke for 2 hours prior to the scanning session. Evaluation will include an interview, questionnaires, and a breath carbon monoxide level. If you are a woman, a urine pregnancy test will be completed prior to the exam. If you smoke, you will be asked to complete questionnaires that focus on your craving and withdrawal symptoms for cigarettes. These questionnaires will take approximately 15 minutes to complete.
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Cigarettes, Smoker, realtime fMRI, brain imaging, imaging
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Nicotine addicted smokers, smoking an average of at least 10 cigarettes per day. | |
| Non-Smokers | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startMar 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark S George, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411007
- Sponsor's protocol ID
- HR#19231
- Acronym
- RTSmoking
- Status last verified
- Jul 2011
- First submitted
- 4 Aug 2011
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Real-time fMRI Feedback on Response to Nicotine Cues
- ClinicalTrials.gov ID
- NCT01411007
- Acronym / sponsor ID
- RTSmoking / HR#19231
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Cigarettes, Smoker, realtime fMRI, brain imaging, imaging
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Aug 2011 (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 develop a technique to provide feedback of brain activity and to use this technique to reduce levels of craving in nicotine dependent smokers. The researchers will use a brain scan called functional magnetic resonance imaging (MRI). MRI uses magnets to take pictures of your brain. Functional MRI measures brain blood flow that is related to brain activity. This measure of brain activity can be presented or "feedback" to volunteers.
Detailed description
There are three total visits for this study. Details of each visit are listed below.
Screening/Assessment Visit:
This evaluation will include interviews, questionnaires, computerized testing, urine drug screen, breath sample for carbon monoxide level and alcohol and physical examination. If accepted into this study, you will then be scheduled for a biofeedback and an imaging session. Both smokers and nonsmoking controls will go through the screening process.
Biofeedback Session:
You will be asked to participate in a biofeedback session scheduled for 60 minutes. You will be comfortably seated and a sensor to measure your temperature will be placed on a finger of your non-dominant hand. You will be asked to make changes in your skin temperature based on feedback from the monitoring system. Your responses to the biofeedback session will be compared to your responses to feedback in the scanner. Both smokers and nonsmoking controls will go through the biofeedback session.
Imaging Visit:
The imaging visit should last approximately 2 hours. You will also be asked to refrain from using alcohol and any street drugs for 24 hours and from using any marijuana for 3 days prior to the visit. If you smoke, you will be asked not to smoke for 2 hours prior to the scanning session. Evaluation will include an interview, questionnaires, and a breath carbon monoxide level. If you are a woman, a urine pregnancy test will be completed prior to the exam. If you smoke, you will be asked to complete questionnaires that focus on your craving and withdrawal symptoms for cigarettes. These questionnaires will take approximately 15 minutes to complete.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | –Nicotine addicted smokers, smoking an average of at least 10 cigarettes per day. |
| Non-Smokers | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult nicotine dependant smokers and Healthy controls
Key inclusion criteria (11 listed)
- Age 18 - 60 right handed adults.
- General good health confirmed by history \& physical.
- Able to read and understand questionnaires and informed consent.
- Participants must have a negative urine drug screen (UDS) and pregnancy test prior to imaging sessions.
- Female participants will use a reliable method of birth control throughout the study.
Key exclusion criteria (12 listed)
- Meets the Diagnostic and Statistical Manual (DSM)-IV criterion for lifetime or current substance dependence except for nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- Use of other tobacco products.
- Current use of nicotine replacement therapy, bupropion, varenicline, or other smoking cessation treatment.
- Healthy volunteers must not have had more than experimental use of cigarettes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
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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.
Mark S George, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by Medical University of South Carolina 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 11 inclusion and 12 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: stopped early, as of the sponsor's last update on 15 Jul 2016. 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 stopped early. Results are not available in the source record.
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.
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 15 Jul 2016.