real time fmri and quitting smoking

Conditions: Nicotine Use Disorder

Summary: 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. 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.

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.

Eligibility criteria:
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.

Keywords: nicotine treatment real time fmri