This study will develop novel low intensity focused ultrasound (LIFU) therapy to help people to quit cigarette smoking. Smoking is associated with cancers of the lung. Available smoking cessation methods help many to quit. However, for the many who continue to smoke despite the strong desire to quit and after exhausting existing therapeutic approaches, new treatment methods are needed. Without more effective treatment, many will continue to smoke, and our progress on cancer prevention through smoking cessation may decelerate as these associated cancer risks will remain. Brain imaging research has identified specific areas of the brain linked to severe nicotine addiction, but up to now there are no effective ways to directly target most of these deeper brain regions. LIFU is a new and safe method to modulate brain functions that can either inhibit overactive activity or restore normal activity levels. The purpose of this study is to provide a novel ultrasound-based neuromodulation strategy for smoking cessation in people who have difficulty to quit smoking despite numerous serious attempts in their lives. LIFU works by sending acoustic pressure modulating neural activity in the human brain.
Must be a smoker for 5 or more years and within 20 to 60 years of age
Must not meet
Must not have ongoing unstable medical, neurological or psychiatric illness as determined by a combination of history, medical record, and/or examination.
Must be a current smoker with average of 5 cigarettes or more a day for the last month or longer.
Report 3 or more trials of smoking cessation attempts using nicotine replacement, e-cig, TMS, varenicline or other smoking cessation drugs, psychotherapy or other means.
Failed TMS screening questionnaire.
Parallel
Low intensity focused ultrasound with active stimulations
DeviceParticipants will receive two LIFU sessions a week for 4 weeks.
low intensity focused ultrasound with sham stimulations
DeviceParticipants will receive two LIFU sessions a week for 4 weeks.
Cigarette per day (CPD)
Cigarette per day (CPD) is measured to index smoking reduction and cessation.
Brain connectivity as indicated by resting state functional connectivity (rsFC) value as assessed by functional magnetic resonance imaging (fMRI)
The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the transcranial magnetic stimulation (TMS) effect on smoking reduction/cessation.
End-expired carbon monoxide (CO)
End-expired CO measure is an instant measure of smoking status, with higher CO level indicating more severe recent smoking behavior.
Urinary cotinine level
Urinary cotinine is an index of smoking status, with higher cotinine concentrations indicating more severe smoking behavior.
Quit rate (%)
Quit rate is an index of smoking cessation effects of the treatment.
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