Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

Study Overview
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Brief Summary
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The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study plans to learn more about the way an experimental technique called transcranial magnetic stimulation (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain. For interested participants, this study requires a single 3 hour appointment, which will include MRI of the brain as well as TMS.

Official Title
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Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

Conditions
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Smoking

Intervention / Treatment
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* Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2
* Device: Sham repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 Ability to provide informed consent Self-reported current average daily cigarette consumption >10/day for at least 1 year Self-reported motivation to quit smoking Exclusion Criteria: MRI/TMS exclusions, including Claustrophobia Intracranial or spinal hardware Pacemakers MR-incompatible devices (Examples: pacemaker, deep brain stimulator, vagal nerve stimulator, cochlear implant, insulin pump, implanted medication pump, bone stimulator, implanted defibrillator) History of metal objects or fragments in the eye or skull, including shrapnel or metal plates History of stroke or other brain lesion History of attempted suicide or suicidal ideation Personal history of headaches, seizures, epilepsy, or status epilepticus Family history of epilepsy Medications known to lower seizure threshold (e.g., tricyclic antidepressants, antipsychotics, psychostimulants) Increased intracranial pressure, hydrocephalus, or pseudotumor cerebri Unstable coronary artery disease Current pregnancy or positive urine pregnancy test Neurological illness Prior neurosurgery Schizophrenia Bipolar disorder Current (within the last two months) major depressive disorder Substance dependence or positive urinalysis for opiates, stimulants, cannabis, or sedative on the day of testing Alcohol dependence or positive breath test for alcohol on the day of testing Use of tobacco products other than cigarettes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inhibitory insular rTMS<br>Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. | Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2<br>* This study plans to learn more about the way an experimental technique called transcranial magnetic stimulation (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.<br>|
| Sham Comparator: Sham insular rTMS<br>Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. | Device: Sham repetitive transcranial magnetic stimulation<br>* Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ | Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ) | 1 hour | 
| Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping |  | 1 hour | 
| Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping |  | 1 hour |