Real Time fMRI and Quitting Smoking

Smoking is the greatest preventable cause of mortality and a significant economic burden.
Even with the best available treatments, most smokers relapse within days or weeks after a
quit attempt. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end
of treatment quit rates of <25% suggesting that managing nicotine withdrawal is not
sufficient. A smoker's response to smoking cues is one factor that increases risk of relapse.
This study will examine how real-time functional magnetic resonance imaging (rt-fMRI)
feedback can be used to modulate brain activation in the context of smoking cues in order to
resist craving. First, we will conduct a pilot study in 12 smokers for technical development
and to evaluate the feasibility of the proposed study procedures. Participants will complete
a total of three fMRI scanning sessions with a cue suppression task with or without
neurofeedback training (NFT). Participants will be randomized to an active group (active NFT)
or a control group (no NFT) during the scanning sessions. At the end of the third session,
all participants will complete a validated smoking lapse laboratory paradigm to evaluate
effects of NFT on smoking behavior. Upon successful completion of the technical development
phase, we will proceed to a proof-of-concept phase, which will recruit 72 smokers to evaluate
the efficacy of NFT for smoking behavior.

Inclusion Criteria:

1. Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at
least 10 cigarettes per day for at least the past 6 months;

2. Planning to live in the area for at least the next month;

3. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the combined consent and HIPAA form;

4. Able to communicate fluently in English (speaking, writing, and reading).

Exclusion Criteria:

Smoking Behavior:

1. Use of chewing tobacco or snuff or cigars;

2. Current enrollment or plans to enroll in another smoking cessation program or research
study in the next month;

3. Current or anticipated (within the next month) use of smoking cessation medications or
nicotine replacement therapy (NRT);

4. A baseline carbon monoxide (CO) reading less than 10ppm.

Alcohol/Drugs:

1. Current alcohol consumption that exceeds 25 standard drinks/week;

2. Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at
intake; a. Participants testing positive for breath alcohol with a reading equal to or
greater than .08 (the legal driving limit) or who are visibly impaired will be
instructed not to drive themselves home after the appointment. If a participant needs
to use a phone to call for a safe ride home, an office telephone will be made
available to the participant.

Medication:

Current use or recent discontinuation (within the past 30 days at the time of Intake) of:

1. Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);

2. Anti-psychotic medications;

3. Any medication that could compromise participant safety as determined by the Principal
Investigator and/or Study Physician;

Daily use of:

4. Opiate-containing medications for chronic pain.

Medical/Neuropsychiatric:

1. Women who are pregnant, planning a pregnancy, and/or breast feeding. All female
subjects of childbearing potential will undergo a urine pregnancy test at Intake and
at each scan session.

2. History of epilepsy or a seizure disorder;

3. History of stroke;

4. Self-reported brain (or CNS) or spinal tumor;

5. Self-reported history of head trauma;

6. Self-reported history or current diagnosis of psychosis.

fMRI-Related:

1. Self-reported use of pacemakers, certain metallic implants, or presence of metal in
the eye as contraindicated for fMRI;

2. Self-reported history of claustrophobia;

3. Being left-handed;

4. Color blindness;

5. Weight greater than 250lbs at intake;

6. Self-reported history of gunshot wounds;

7. Any impairment preventing participants from using the response pad necessary for the
computer tasks;

8. Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).

General Exclusion:

1. Any medical condition, illness, disorder, or concomitant medication that could
compromise participant safety or treatment, as determined by the Principal
Investigator;

2. Enrollment or plans to enroll in another research study;

3. Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator.