rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Cigarette Smoker, Current Every Day Smoker, Current Smoker

In brief

This trial studies best dose and how well repetitive transcranial magnetic stimulation (rTMS) works in promoting smoking cessation and preventing relapse in current smokers. rTMS is a form of brain stimulation therapy that controls nerve cell activity, increases blood flow in the brain, and improves cognitive function.

Key facts

Study ID

NCT03865472

Run by

Roswell Park Cancer Institute

People needed

206

Starts

2018-11-10

Expected to finish

2026-11-13

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants will be right-handed
• 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
• Study 1: Participants will be right-handed and have been diagnosed with primary non-small and small cell lung cancer or with non-skin squamous cell HNC (self-reported)
• Study 1: Age 18+
• Study 1: Negative urine drug screen at the baseline assessment
• Study 1: Ability to read at the 8th grade level
• Study 1: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
• Study 1: Participants must smoke at least 4 cigarettes per day and intend to quit smoking in the next 60 days
• Study 1: Has been diagnosed with primary non-small cell LC or with primary non-skin squamous cell HNC (self-reported)
• Study 2: Participants will be healthy right-handed adults
• Study 2: Age 18-65 years old
• Study 2: Negative urine drug screen at the baseline assessment
• Study 2: Ability to read at the 8th grade level
• Study 2: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
• Study 2: Participants must smoke between 5 and 25 cigarettes per day with the intent to quit smoking in the next 30 days
• Study 2: Meet the criteria for heavy alcohol use: > 7 drinks per week for women, > 15 drinks per week for men OR binge drinking >= 5 days in the past month. Binge drinking is defined as >= 4 drinks for women and >= 5 drinks for men, consumed within 2 hours of each other
• Study 2: 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

You may not qualify if…

• Has a personal history of epilepsy
• Has a history of anticonvulsant medication use
• Has a personal history of head injury
• Has a History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the magnetic resonance imaging (MRI) (e.g., tumor, aneurism, etc.)
• Has uncontrolled major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
• Has any metal implants or neuro-stimulators in the head, neck, or cochlea that prevent an MRI being performed
• Has a pacemaker
• Personal history of 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 including e-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
• Individuals who score >15, indicative of moderate-severe Alcohol Use Disorder, on the Alcohol Use Disorders Identification Test (AUDIT).
• 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
• Study 1:Has a personal history of Brain metastases
• Study 1: Unable to use nicotine patches
• Study 1: Has a Personal history of epilepsy
• Study 1: Has a History of anticonvulsant medication use
• Study 1: Has a Personal history of head injury
• Study 1: History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
• Study 1: A diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
• Study 1: Has any Metal implants or neuro-stimulators in the head, neck, or cochlea that prevent an MRI being performed
• Study 1: Has a pacemaker

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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