Cigarette SmokerNCT03865472
rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers
A study testing Questionnaire Administration and Repetitive Transcranial Magnetic Stimulation in people with Cigarette Smoker and Current Every Day Smoker, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker, Current Smoker
- What is being tested?
- Questionnaire Administration and Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2018to 13 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Enhancing Relapse Prevention With rTMS: Dose-Response Parameters for Smoking Cessation
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
III. To examine the effects of 16 20Hz rTMS sessions combined with intensive cognitive behavioral treatment and nicotine replacement on smoking cessation, developmental disability (DD rates), cognitive behavioral skill acquisition, and nicotine patch adherence among lung cancer (LC) patients (n=30). (Study 1 and Study 2) IV. To examine the feasibility and potential efficacy of 20Hz rTMS on the left dorsolateral prefrontal cortex (DLPFC) for concurrent smoking abstinence and reductions in alcohol use among smokers who are heavy drinkers (n=20). (Study 1 and Study 2)
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.
- Conditions
- Cigarette Smoker, Current Every Day Smoker, Current Smoker
- Being tested
- Questionnaire Administration, Repetitive Transcranial Magnetic Stimulation, Sham Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Repetitive Transcranial Magnetic StimulationProcedure or surgery
Also called rTMS
Undergo rTMS
Sham InterventionProcedure or surgery
Undergo sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| Arm I (rTMS) | Experimental | Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days. Receives: Other: Questionnaire Administration; Procedure: Repetitive Transcranial Magnetic Stimulation |
| Arm II (sham rTMS) | Sham comparator | Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days. Receives: Other: Questionnaire Administration; Procedure: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to relapse
Latency to relapse will be defined as the number of days from the quit day to relapse. Relapse will be defined as smoking for seven consecutive days. Will use Cox proportional-hazards (CPH) models to examine latency to relapse outcome. Ties in failure times will be handled using methods developed by Efron. Compliance with the CPH assumptions will be tested by coding the factors as time-dependent covariates.
Measured: Up to 30 days
Secondary outcomes (5)
Point-prevalence abstinence rates
Will use logistic regression models to examine binary 12 and 24-week point prevalence abstinence.
Measured: At 12 and 24 weeks after quit date
Delay discounting rates
Will be examined through using repeated measures Generalized Linear models.
Measured: At 12 and 24 weeks after quit date
Cognitive-behavioral Therapy Skills Questionnaire
Cognitive behavioral skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ)
Measured: Up to 24 weeks
Side effects
Potential undesirable effects will be measured up to 24 weeks.
Measured: Up to 24 weeks
Forever Free (FF) Booklet content Exposure
Will be measured in terms of number of content segments in each booklet.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start10 Nov 2018
- Primary completion13 Nov 2025
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christine Sheffer, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865472
- Sponsor's protocol ID
- i 65718
- Other IDs
- NCI-2018-03300, i 65718, R01CA229415
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2019
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shevorykin A, Carl E, Liskiewicz A, Hanlon CA, Bickel WK, Mahoney MC, Vantucci D, Bensch L, Thorner H, Marion M, Sheffer CE. Perceived research burden of a novel therapeutic intervention: A study of transcranial magnetic stimulation for smoking cessation. Front Rehabil Sci. 2023 Mar 3;4:1054456. doi: 10.3389/fresc.2023.1054456. eCollection 2023.
PubMed 36937103Shevorykin A, Carl E, Mahoney MC, Hanlon CA, Liskiewicz A, Rivard C, Alberico R, Belal A, Bensch L, Vantucci D, Thorner H, Marion M, Bickel WK, Sheffer CE. Transcranial Magnetic Stimulation for Long-Term Smoking Cessation: Preliminary Examination of Delay Discounting as a Therapeutic Target and the Effects of Intensity and Duration. Front Hum Neurosci. 2022 Jul 5;16:920383. doi: 10.3389/fnhum.2022.920383. eCollection 2022.
PubMed 35874156Carl E, Liskiewicz A, Rivard C, Alberico R, Belal A, Mahoney MC, Quisenberry AJ, Bickel WK, Sheffer CE. Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial. BMC Psychol. 2020 May 1;8(1):42. doi: 10.1186/s40359-020-00403-7.
PubMed 32357940
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Relapse Prevention With rTMS: Dose-Response Parameters for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03865472
- Acronym / sponsor ID
- i 65718
- Conditions
- Cigarette Smoker, Current Every Day Smoker, Current Smoker
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
III. To examine the effects of 16 20Hz rTMS sessions combined with intensive cognitive behavioral treatment and nicotine replacement on smoking cessation, developmental disability (DD rates), cognitive behavioral skill acquisition, and nicotine patch adherence among lung cancer (LC) patients (n=30). (Study 1 and Study 2) IV. To examine the feasibility and potential efficacy of 20Hz rTMS on the left dorsolateral prefrontal cortex (DLPFC) for concurrent smoking abstinence and reductions in alcohol use among smokers who are heavy drinkers (n=20). (Study 1 and Study 2)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (rTMS) | Experimental | Other: Questionnaire Administration, Procedure: Repetitive Transcranial Magnetic StimulationPatients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days. |
| Arm II (sham rTMS) | Sham comparator | Other: Questionnaire Administration, Procedure: Sham InterventionPatients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (49 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | Arm I (rTMS), Arm II (sham rTMS) |
| Repetitive Transcranial Magnetic StimulationAlso: rTMSUndergo rTMS | Procedure or surgery | Arm I (rTMS) |
| Sham InterventionUndergo sham rTMS | Procedure or surgery | Arm II (sham rTMS) |
Primary outcome
Latency to relapse
Time frame: Up to 30 days
Latency to relapse will be defined as the number of days from the quit day to relapse. Relapse will be defined as smoking for seven consecutive days. Will use Cox proportional-hazards (CPH) models to examine latency to relapse outcome. Ties in failure times will be handled using methods developed by Efron. Compliance with the CPH assumptions will be tested by coding the factors as time-dependent covariates.
5 secondary outcomes
Point-prevalence abstinence rates
Time frame: At 12 and 24 weeks after quit date
Delay discounting rates
Time frame: At 12 and 24 weeks after quit date
Cognitive-behavioral Therapy Skills Questionnaire
Time frame: Up to 24 weeks
Side effects
Time frame: Up to 24 weeks
Forever Free (FF) Booklet content Exposure
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Derived from this study: PubMed 36937103Shevorykin A, Carl E, Liskiewicz A, Hanlon CA, Bickel WK, Mahoney MC, Vantucci D, Bensch L, Thorner H, Marion M, Sheffer CE. Perceived research burden of a novel therapeutic intervention: A study of transcranial magnetic stimulation for smoking cessation. Front Rehabil Sci. 2023 Mar 3;4:1054456. doi: 10.3389/fresc.2023.1054456. eCollection 2023.
- Derived from this study: PubMed 35874156Shevorykin A, Carl E, Mahoney MC, Hanlon CA, Liskiewicz A, Rivard C, Alberico R, Belal A, Bensch L, Vantucci D, Thorner H, Marion M, Bickel WK, Sheffer CE. Transcranial Magnetic Stimulation for Long-Term Smoking Cessation: Preliminary Examination of Delay Discounting as a Therapeutic Target and the Effects of Intensity and Duration. Front Hum Neurosci. 2022 Jul 5;16:920383. doi: 10.3389/fnhum.2022.920383. eCollection 2022.
- Derived from this study: PubMed 32357940Carl E, Liskiewicz A, Rivard C, Alberico R, Belal A, Mahoney MC, Quisenberry AJ, Bickel WK, Sheffer CE. Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial. BMC Psychol. 2020 May 1;8(1):42. doi: 10.1186/s40359-020-00403-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Sheffer principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Repetitive Transcranial Magnetic Stimulation in people with Cigarette Smoker and Current Every Day Smoker, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency to relapse (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865472, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.