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

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.

Study Overview

• Status: Terminated
• Conditions: Nicotine Dependence

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 Type: Observational
• Enrollment (Anticipated): 44

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult nicotine dependant smokers and Healthy controls

Description

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 urine drug screen (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 Fagerström Test for Nicotine Dependence (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 Questionnaire of Smoking Urges (QSU)-B.

Exclusion Criteria:(all participants):

1. Meets the Diagnostic and Statistical Manual (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 Driving Under the Influence (DUI) related offenses).
12. Persons with ferrous metal implants or pacemaker since fMRI will be used.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Smokers; Nicotine addicted smokers, smoking an average of at least 10 cigarettes per day.
Non-Smokers

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Mark S George, M.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 4, 2011
• First Submitted That Met QC Criteria: August 4, 2011
• First Posted (Estimate): August 5, 2011

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: imaging; Cigarettes; Nicotine; Smoker; brain imaging; realtime fMRI
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: HR#19231