Real Time fMRI and Quitting Smoking
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Real-time neurofeedback training group 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
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.
|
| No Intervention: No-feedback control group 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. |
Outcome Measures
Primary Outcome Measures
- Smoking Lapse Paradigm [Study session 3 (scan day 3)]
Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory
Secondary Outcome Measures
- Cue induced brain signal change [Study session 3 (scan day 3)]
Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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Planning to live in the area for at least the next month;
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Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
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Able to communicate fluently in English (speaking, writing, and reading).
Exclusion Criteria:
Smoking Behavior:
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Use of chewing tobacco or snuff or cigars;
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Current enrollment or plans to enroll in another smoking cessation program or research study in the next month;
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Current or anticipated (within the next month) use of smoking cessation medications or nicotine replacement therapy (NRT);
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A baseline carbon monoxide (CO) reading less than 10ppm.
Alcohol/Drugs:
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Current alcohol consumption that exceeds 25 standard drinks/week;
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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:
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Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);
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Anti-psychotic medications;
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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:
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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.
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History of epilepsy or a seizure disorder;
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History of stroke;
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Self-reported brain (or CNS) or spinal tumor;
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Self-reported history of head trauma;
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Self-reported history or current diagnosis of psychosis.
fMRI-Related:
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Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI;
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Self-reported history of claustrophobia;
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Being left-handed;
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Color blindness;
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Weight greater than 250lbs at intake;
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Self-reported history of gunshot wounds;
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Any impairment preventing participants from using the response pad necessary for the computer tasks;
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Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).
General Exclusion:
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Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator;
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Enrollment or plans to enroll in another research study;
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Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 828012