rTMS for Smoking Cessation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must not be taking: Anticonvulsants, Tricyclic antidepressants

Disqualifiers: Epilepsy, Head injury, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of repetitive transcranial magnetic stimulation (rTMS), a type of brain therapy, in helping people quit smoking and avoid relapse. Participants will receive either real rTMS or a sham version to compare outcomes. Ideal candidates are right-handed individuals who smoke between 5 and 25 cigarettes daily and plan to quit soon. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in smoking cessation therapy.

Will I have to stop taking my current medications?

Participants must stop taking medications that lower the seizure threshold, such as tricyclic antidepressants or bupropion, and any medications used for tobacco cessation like nicotine replacement, bupropion, or varenicline.

What prior data suggests that rTMS is safe for smoking cessation?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), a type of brain stimulation, is generally safe. In studies involving individuals trying to quit smoking, participants have tolerated rTMS well. For example, a study with cancer patients using rTMS to aid smoking cessation reported only minor issues. One participant experienced back pain, but it occurred after a placebo treatment, and recovery was swift.

No serious side effects have been commonly linked to rTMS itself. Most studies focus on its ability to reduce cravings and smoking, demonstrating that it can help lower the number of cigarettes smoked daily. Overall, rTMS appears safe, with few reports of concerning side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it offers a non-invasive approach to help people quit smoking, unlike traditional methods like nicotine replacement therapies, medications, or behavioral therapies. rTMS works by using magnetic fields to stimulate specific areas of the brain associated with addiction and cravings, potentially reducing the urge to smoke. Researchers are excited about this treatment because it provides a novel mechanism of action that directly targets brain activity, offering hope for those who haven't had success with other methods. Additionally, it could lead to quicker results compared to some traditional treatments, which often require extended periods to show effectiveness.

What evidence suggests that rTMS is effective for smoking cessation?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial may receive, can help people stop smoking. Studies have found that rTMS lowers cravings for cigarettes and reduces the number of cigarettes smoked. One analysis found that people who received rTMS smoked fewer cigarettes each day than those who did not. Another study suggested that rTMS could help decrease nicotine addiction. Overall, evidence supports rTMS as a helpful tool for quitting smoking. Participants in this trial may also be assigned to a sham rTMS group, serving as a control to evaluate the effectiveness of the actual rTMS treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Christine Sheffer

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for right-handed adults who smoke 5-25 cigarettes daily and want to quit within the next 30 days. They must be able to read at an 8th-grade level, pass a safety questionnaire, have no drug use, and not be heavy alcohol users. It's not for those with metal implants in the head/neck, pacemakers, certain mental health disorders, or on seizure-lowering or tobacco cessation meds.

Inclusion Criteria

Participants will be right-handed lung cancer patients

Negative urine drug screen at the baseline assessment

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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo rTMS or sham rTMS once or twice daily over 16 minutes for 8, 12, or 16 days

2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive-behavioral therapy skills and side effects

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation
• Sham Intervention

Trial Overview The trial is testing repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain therapy that may help control nerve activity and promote smoking cessation. Participants will either receive rTMS or a sham intervention while their cognitive function and blood flow in the brain are monitored.

How Is the Trial Designed?

Group I: Arm I (rTMS) Experimental Treatment 2 Interventions

Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days.

Group II: Arm II (sham rTMS) Placebo Group 2 Interventions

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

Repetitive Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Migraines

Approved in European Union as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Anxiety disorders

Approved in Canada as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 42 treatment-seeking smokers, 10 sessions of repetitive transcranial magnetic stimulation (rTMS) significantly reduced daily cigarette consumption by 62.93% compared to a 39.43% reduction with sham treatment, indicating its efficacy in tobacco use disorders.

fMRI results showed that rTMS increased activity in brain areas associated with executive control (dorsal anterior cingulate cortex and DLPFC) while decreasing activity in reward-related areas (medial orbitofrontal cortex), suggesting a mechanism of action that enhances self-control and reduces craving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced executive and reward connectivity is associated with smoking cessation response to repetitive transcranial magnetic stimulation: A double-blind, randomized, sham-controlled trial. Li, X., Caulfield, KA., Hartwell, KJ., et al.[2023]

In a study of 37 smokers with severe nicotine dependence, combining 1-Hz repetitive Transcranial Magnetic Stimulation (rTMS) with Nicotine Replacement Therapy (NRT) significantly increased abstinence rates, with 16 out of 18 participants in the active rTMS group remaining abstinent compared to 9 out of 19 in the sham group.

Active rTMS also led to a significant reduction in craving levels, particularly in the compulsive aspect of cravings, suggesting that rTMS may help manage withdrawal symptoms during smoking cessation, although the effects did not persist long-term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. Trojak, B., Meille, V., Achab, S., et al.[2018]

A single session of high-frequency rTMS (10 Hz) over the left dorsolateral prefrontal cortex significantly reduced cigarette craving in 16 nicotine-dependent participants, demonstrating its potential efficacy as a noninvasive treatment.

The reduction in craving was notably greater with real rTMS compared to sham treatment, suggesting that rTMS may be a promising tool for aiding smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Li, X., Hartwell, KJ., Owens, M., et al.[2022]

A multicenter double-blind RCT involving 262 chronic smokers showed that repetitive transcranial magnetic stimulation (rTMS) significantly increased the continuous quit rate (CQR) to 19.4% compared to 8.7% for the sham treatment, indicating its efficacy in promoting smoking cessation.

This study established a safe treatment protocol for rTMS, which has now received FDA clearance as an aid for smoking cessation, marking a significant advancement in addiction medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. Zangen, A., Moshe, H., Martinez, D., et al.[2021]

In a study involving 11 cancer patients who smoke, 5 sessions of repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex showed modest reductions in cigarette consumption and significant decreases in craving, indicating potential efficacy for smoking cessation.

No serious side effects were reported from the rTMS treatment, suggesting it is a safe option for cancer patients seeking to quit smoking, although more research is needed to confirm its effectiveness and safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. Li, X., Toll, BA., Carpenter, MJ., et al.[2022]

In a pilot study involving 11 tobacco-dependent smokers, repetitive transcranial magnetic stimulation (rTMS) significantly reduced cravings for tobacco compared to placebo, suggesting its potential as a therapeutic intervention.

Given that traditional smoking cessation methods have low long-term success rates, rTMS may offer a new approach to help increase abstinence rates among smokers who want to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitiv Transcranial Magnetic Stimulation in Nicotine Dependence] Johann, M., Wiegand, R., Kharraz, A., et al.[2019]

In a study of 23 participants, repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex showed that increasing the duration of treatment significantly improved the odds of smoking abstinence by 7-8 times, while increasing the intensity of sessions doubled the odds.

The research suggests that delay discounting rates, which relate to impulsivity in decision-making, could be a valuable target for smoking cessation therapies, with both duration and intensity of rTMS treatment contributing to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for Long-Term Smoking Cessation: Preliminary Examination of Delay Discounting as a Therapeutic Target and the Effects of Intensity and Duration. Shevorykin, A., Carl, E., Mahoney, MC., et al.[2022]

A pilot study involving 11 tobacco-dependent smokers found that repetitive transcranial magnetic stimulation (rTMS) significantly reduced cravings for tobacco compared to a placebo, suggesting its potential as a therapeutic intervention.

Given that traditional smoking cessation methods have low success rates (around 30% abstinence after 12 months), rTMS may offer a promising alternative to help increase tobacco abstinence rates in smokers looking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial magnetic stimulation for nicotine dependence]. Johann, M., Wiegand, R., Kharraz, A., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10890232/

Repetitive transcranial magnetic stimulation for smoking ... Second-line interventions for smoking cessation, such as combination therapies of varenicline and NRT, show 32.4% abstinence rates at 6 months. ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178123002901

Repetitive transcranial magnetic stimulation for smoking ... In general, studies support the efficacy of multi-session, high-frequency rTMS in reducing drug craving and consumption (Ekhtiari et al., 2019, Hauer et al., ...

3. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-025-00558-2

Efficacy of repetitive transcranial magnetic stimulation for ... Conclusion. rTMS shows promising potential as an adjunctive treatment for smoking cessation by reducing nicotine dependence (to some extent) and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9293555/

Repetitive Transcranial Magnetic Stimulation for Tobacco ... Brains way announces successful results in pivotal multicenter study evaluating deep transcranial magnetic stimulation system as an aid in smoking cessation.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834325001070

Effectiveness and safety of repeated transcranial magnetic ... The meta-analysis showed that, comparing with the control group, active rTMS significantly decreased the average daily number of cigarettes smoked (MD = −6.72, ...

6. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-025-00503-3

Efficacy and safety of repetitive transcranial magnetic ... This study aimed to assess the effectiveness of active r-TMS in reducing smoking behavior, withdrawal symptoms, cravings, and nicotine dependence