Nicotine TMS EFT Smoking Pilot Study

Study Overview
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Brief Summary
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Prior and recent evidence suggests a role of medial prefrontal cortex (MPFC) in cigarette smoking. Episodic Future Thinking (EFT) has also been shown to be associated with increased delayed discounting and reduced cigarette self administration. In the present study, we will examine whether a single administration of theta-burst transcranial magnetic stimulation (tbTMS) can increase Episodic Future Thinking and delayed discounting while reducing craving for nicotine.

Detailed Description
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The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS) as a potential treatment for nicotine addiction. Theta burst TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether tbTMS over the forehead can produce a reduction in things that may prompt individuals to want to smoke cigarettes. TMS has been approved by the Food and Drug Administration as an investigational tool as well as a therapy for depression. However, TMS is not approved by the Food and Drug Administration as a treatment for nicotine cravings and other addictions. This study consists of one consent session and one TMS session. Participants will be asked to complete a series of questionnaires and computer assessments about nicotine both before and after a single tbTMS session.

Official Title
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Theta-Burst Stimulation As A Tool To Change Smoking Behavior

Conditions
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Addiction, Smoking, Cigarette, Smoking, Nicotine Dependence

Intervention / Treatment
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* Device: Real cTBS
* Device: Sham cTBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age Smoke at least 10 cigarettes a day (on average) Not be pregnant Meet all criteria on a standardized TMS safety screen (including to but not limited to implanted electronic devices, bullets or metallic fragments above the neck, hair clips that cannot be removed) No barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove) Exclusion Criteria: Report comorbid mental or physical illness (managed or unmanaged) Currently using prescription medication that might affect smoking or nicotine metabolism Using smokeless tobacco or alternative nicotine products History of epilepsy or seizures (other than childhood febrile seizures) History of chronic migraines

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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No

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real cTBS to MPFC<br>One session of real cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total). | Device: Real cTBS<br>* This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).<br>|
| Sham Comparator: Sham cTBS to MPFC<br>One session of sham cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total). | Device: Sham cTBS<br>* This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in craving after a single session of cTBS | The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in nicotine craving scores. | For the duration of the study, approximately 24 hours following real or sham cTBS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in delayed discounting after a single session of cTBS | The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in delayed discounting scores. | For the duration of the study, approximately 24 hours following real or sham cTBS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Stimulation