Status:
TERMINATED
The Impact of Real-time Functional Magnetic Resonance Imaging (fMRI) Feedback on Response to Nicotine Cues
Lead Sponsor:
Medical University of South Carolina
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-60 years
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all participants):
- Age 18 - 60 right handed adults.
- General good health confirmed by history \& physical.
- Able to read and understand questionnaires and informed consent.
- Participants must have a negative urine drug screen (UDS) and pregnancy test prior to imaging sessions.
- 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:
- 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.
- Smokers must be motivated to quit.
- Demonstrate subjective craving as measured by the Questionnaire of Smoking Urges (QSU)-B.
- Exclusion Criteria:(all participants):
- Meets the Diagnostic and Statistical Manual (DSM)-IV criterion for lifetime or current substance dependence except for nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- Use of other tobacco products.
- Current use of nicotine replacement therapy, bupropion, varenicline, or other smoking cessation treatment.
- Healthy volunteers must not have had more than experimental use of cigarettes.
- 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.
- Current suicidal ideation with plan or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
- Clinically significant medical problems that would impair participation or limit ability to participate in scan.
- 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.
- Has current charges pending for a violent crime (not including Driving Under the Influence (DUI) related offenses).
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01411007
Start Date
March 1 2010
End Date
February 1 2016
Last Update
July 15 2016
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425