Zapping the brain to kick the habit: rTMS tested for smoking relapse
NCT ID NCT03865472
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, to help current smokers quit and avoid relapse. Researchers are enrolling 206 right-handed smokers who smoke 5-25 cigarettes daily and want to quit within 30 days. The goal is to find the best dose of rTMS and see how well it works compared to a sham (fake) treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- repetitive transcranial magnetic stimulation (rTMS)
- What this could lead to
- If successful, this could provide a non-drug brain stimulation method to help smokers quit and stay smoke-free for longer.
- What could go wrong
- This is an early dose-finding study, so the best dose and effectiveness are not yet known. Results may not apply to all smokers, and rTMS may not prevent relapse for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
206 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Study 1: Personal history of Migraine headaches * Study 1: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion) * Study 1: Currently using bupropion or varenicline for smoking cessation * Study 1: Pregnant or planning to become pregnant in the next 24 weeks * Study 1: Current regular use of forms of tobacco other than cigarettes * Study 1: 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 a magnetic resonance imaging (MRI) scan without distress * Study 1: Unwilling or unable to follow protocol requirements * Study 1: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study * Study 2: Has a personal history of epilepsy * Study 2: Has a history of anticonvulsant medication use * Study 2: Has a personal history of head injury * Study 2: Has a history of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.) * Study 2: Has a diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus * Study 2: Has any metal implants or neuro-stimulators in the head, neck, or cochlea that prevent an MRI being performed * Study 2: Has a pacemaker * Study 2: Personal history of Migraine headaches * Study 2: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion) * Study 2: Currently using medications for tobacco cessation (e.g., nicotine replacement, bupropion, varenicline, etc.) * Study 2: Pregnant or planning to become pregnant in the next 24 weeks * Study 2: Current regular use of forms of tobacco other than cigarettes * Study 2: 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 a magnetic resonance imaging (MRI) without distress * Study 2: Meet the criteria for severe alcohol use disorder (AUD) (\> 6 symptoms) or have ever met Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V) criteria for alcohol withdrawal. Heavy drinking and AUD are not mutually exclusive. * Study 2: Unwilling or unable to follow protocol requirements * Study 2: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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