Real Time fMRI and Quitting Smoking

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Proof-of-concept Study of Real-time fMRI Neurofeedback Training for Smoking Cessation

Conditions
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Nicotine Use Disorder

Intervention / Treatment
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* Behavioral: Realtime biofeedback using fMRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Planning to live in the area for at least the next month; Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form; Able to communicate fluently in English (speaking, writing, and reading). Exclusion Criteria: Smoking Behavior: Use of chewing tobacco or snuff or cigars; Current enrollment or plans to enroll in another smoking cessation program or research study in the next month; Current or anticipated (within the next month) use of smoking cessation medications or nicotine replacement therapy (NRT); A baseline carbon monoxide (CO) reading less than 10ppm. Alcohol/Drugs: Current alcohol consumption that exceeds 25 standard drinks/week; 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: Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT); Anti-psychotic medications; Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician; Daily use of: Opiate-containing medications for chronic pain. Medical/Neuropsychiatric: 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. History of epilepsy or a seizure disorder; History of stroke; Self-reported brain (or CNS) or spinal tumor; Self-reported history of head trauma; Self-reported history or current diagnosis of psychosis. fMRI-Related: Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI; Self-reported history of claustrophobia; Being left-handed; Color blindness; Weight greater than 250lbs at intake; Self-reported history of gunshot wounds; Any impairment preventing participants from using the response pad necessary for the computer tasks; Circumstances or conditions that may interfere with magnetic resonance imaging (MRI). General Exclusion: Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator; Enrollment or plans to enroll in another research study; Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed study will evaluate the effects of rt-fMRI neurofeedback training on the ability to resist craving for cigarettes. The study will be conducted in two phases: a technical development phase and a proof-of-concept phase focused on efficacy. The technical development phase will be completed before beginning the proof-of-concept phase. Eligible consenting treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group. Both groups will complete three scanning sessions, followed by a smoking resist evaluation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time neurofeedback training group<br>We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In this arm, participants will complete four sessions: an intake session and 3 neurofeedback scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes. | Behavioral: Realtime biofeedback using fMRI<br>* Real-time fMRI (rt-fMRI) allows for rapid analysis of brain activation while an individual is actively performing a task, and can be used to provide real-time neurofeedback to individuals during fMRI scanning. Using neurofeedback, individuals can learn to modulate activity in specific regions of the brain. We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. Participants will complete four sessions: an intake session and 3 scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm.<br>|
| No Intervention: No-feedback control group<br>We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In the control group arm, participants will complete four sessions: an intake session and 3 scanning visits with no neurofeeback. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Lapse Paradigm | Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory | Study session 3 (scan day 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cue induced brain signal change | Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions | Study session 3 (scan day 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine treatment, real time fMRI