View Clinical Trial (Medical Research Study)
The Impact of Real-time fMRI Feedback on Response to Nicotine Cues
| City: |
|
Charleston |
| State: |
|
South Carolina |
| Zip Code: |
|
29425 |
| Conditions: |
|
Nicotine Dependence |
| Purpose: |
|
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 "fedback"
to volunteers.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
Inclusion Criteria (all participants):
1. Age 18 - 60 right handed adults.
2. General good health confirmed by history & physical.
3. Able to read and understand questionnaires and informed consent.
4. Participants must have a negative UDS and pregnancy test prior to imaging sessions.
5. Female participants will use a reliable method of birth control throughout the study.
Additional Inclusion Criteria for non-smoking group:
1. Has used tobacco products no more than on experimental basis (none in past year).
Additional Inclusion Criteria for smoking group:
1. Smokers must meet criteria for primary nicotine dependence confirmed by FTND and
smoking on average 10 cigarettes a day in the last 30 days prior to assessment.
2. Smokers must be motivated to quit.
3. Demonstrate subjective craving as measured by the QSU-B.
Exclusion Criteria:(all participants):
1. Meets the DSM-IV criterion for lifetime or current substance dependence except for
nicotine dependence.
2. Any psychoactive substance abuse within the last 30 days as evidenced by subject
report or urine drug screen.
3. Use of other tobacco products.
4. Current use of nicotine replacement therapy, bupropion, varenicline, or other smoking
cessation treatment.
5. Healthy volunteers must not have had more than experimental use of cigarettes.
6. 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.
7. Current suicidal ideation with plan or homicidal ideation.
8. Need for maintenance or acute treatment with any psychoactive medication including
anti-seizure medications which could potentially interfere with fMRI.
9. Clinically significant medical problems that would impair participation or limit
ability to participate in scan.
10. 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.
11. Has current charges pending for a violent crime (not including DUI related offenses).
12. Persons with ferrous metal implants or pacemaker since fMRI will be used.
|
| NCT ID: |
|
NCT01411007 |
| Primary Contact: |
|
Principal Investigator
Mark S George, M.D.
Medical University of South Carolina
Harvey Frampton
Phone: 8437928938
Email: frampton@musc.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Charleston, South Carolina 29425
United States
Harvey A Frampton
Phone: 843-792-8938
Email: frampton@musc.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 22, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|