rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

PRIMARY OBJECTIVES:

I. To examine the effects of stimulation duration (stimulation days) and intensity (pulses
per day) on outcomes among smokers (sample size [n]=258) motivated to quit.

II. To identify the most promising dosing strategy by balancing effect sizes and undesirable
effects.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo rTMS once daily (QD) or twice daily (BID) over 16 minutes for 8, 12,
or 16 days.

ARM II: Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days.

Inclusion Criteria:

- Participants will be healthy right-handed adults

- Negative urine drug screen at the baseline assessment

- Ability to read at the 8th grade level

- Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire
(TASS)

- Participants must smoke between 5 and 25 cigarettes per day with the intent to quit
smoking in the next 30 days

- Participant or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Personal history of epilepsy

- History of anticonvulsant medication use

- Personal history of head injury

- History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on
the magnetic resonance imaging (MRI) (e.g., tumor, aneurism, etc.)

- A diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum
disorder, or tinnitus

- Metal implants or neuro-stimulators in the head, neck, or cochlea

- A pacemaker

- Migraine headaches

- Currently taking medications that lower seizure threshold (e.g., such as tricyclic
antidepressants or bupropion)

- Currently using medications for tobacco cessation (e.g., nicotine replacement,
bupropion, varenicline, etc?)

- Pregnant or planning to become pregnant in the next 24 weeks

- Current regular use of forms of tobacco other than cigarettes

- Participants who score above 48.3 on the Claustrophobia Questionnaire at the baseline
assessment will be excluded because they are likely to be unable to undergo an
magnetic resonance imaging (MRI) without distress

- Unwilling or unable to follow protocol requirements

- Any condition which in the Investigator?s opinion deems the participant an unsuitable
candidate to participate in the study