Trials / Terminated
TerminatedNCT01411007
The Impact of Real-time Functional Magnetic Resonance Imaging (fMRI) Feedback on Response to Nicotine Cues
The Impact of Real-time fMRI Feedback on Response to Nicotine Cues
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 44 (estimated)
- Sponsor
- Medical University of South Carolina · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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. 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.
Conditions
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2011-08-05
- Last updated
- 2016-07-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01411007. Inclusion in this directory is not an endorsement.