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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01411007
First received: August 4, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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.


Condition
Nicotine Dependence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Real-time fMRI Feedback on Response to Nicotine Cues

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Smokers
Nicotine addicted smokers, smoking an average of at least 10 cigarettes per day.
Non-Smokers

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult nicotine dependant smokers and Healthy controls

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411007

Contacts
Contact: Harvey Frampton 8437928938 frampton@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Harvey A Frampton    843-792-8938    frampton@musc.edu   
Contact: Todd A LeMatty    8437928179    lematty@musc.edu   
Principal Investigator: Mark S George, M.D.         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Mark S George, M.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Mark George M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01411007     History of Changes
Other Study ID Numbers: HR#19231
Study First Received: August 4, 2011
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Nicotine
Cigarettes
Smoker
realtime fMRI
brain imaging
imaging

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014