The Impact of Real-time Functional Magnetic Resonance Imaging (fMRI)

Status Terminated

Clinical 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. Functional MRI measures brain blood flow that is related to brain activity. This measure of brain activity can be presented or "feedback" to volunteers.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01411007
Study type	Observational
Source	Medical University of South Carolina
Contact
Status	Terminated
Phase	N/A
Start date	March 2010
Completion date	February 2016

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Impact of Real-time Functional Magnetic Resonance Imaging (fMRI) Feedback on Response to Nicotine Cues — RTSmoking

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms