Theta Burst TMS as a Tool to Change Smoking Behavior

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

Detailed Description
-----------------
Prior and recent evidence suggests a role of medial prefrontal cortex (mPFC) in cigarette smoking. The present study will examine whether a five-day regimen of theta-burst transcranial magnetic stimulation (TMS) reduces cigarette smoking outside of the lab (examined through self-report and physiological measures) and motivation to smoke inside the lab (examined through behavioral tasks and functional MRI).

Official Title
-----------------
Theta Burst TMS as a Tool to Change Smoking Behavior

Conditions
-----------------
Smoking, Addiction

Intervention / Treatment
-----------------
* Device: continuous theta burst stimulation (real)
* Device: continuous theta burst stimulation (sham)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: smoke at least 10 cigarettes a day (on average) Exclusion Criteria: comorbid mental or physical illness (managed or unmanaged) pregnancy use of prescription medication that might affect smoking or nicotine metabolism, use of smokeless tobacco or alternative nicotine products use illicit drugs of abuse (verified through urine screen and self-report), score of above a 7 on the Alcohol Use Disorders Identification Test (indicative of non-risky use), a history of epilepsy or seizures not otherwise specified (other than childhood febrile seizures) a history of chronic migraines, failure to meet all criteria on a standardized MRI/TMS safety screen (including but not limited to implanted electronic devices, bullets or metallic fragments above the waist, hair clips and piercings above the waist that cannot be removed) presence of any 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).

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real treatment<br>continuous theta burst stimulation (real) will be delivered | Device: continuous theta burst stimulation (real)<br>* a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity<br>* Other names: cTBS (active);|
| Sham Comparator: sham treatment<br>continuous theta burst stimulation (sham) will be delivered | Device: continuous theta burst stimulation (sham)<br>* a sham version of a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity<br>* Other names: cTBS (sham);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent BOLD signal change in the MPFC | The effect of real vs. sham cTBS to the leftt MPFC as a tool to modulate the brain response to craving will be assessed by comparing the brain activity in the limbic circuit before and after TMS. | immediately after the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Magnetic Stimulation