Transcranial Magnetic Stimulation for Smoking

Overseen By Alexandra S, BScH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Anticonvulsants, Benzodiazepines

Disqualifiers: Intracranial implants, Pregnancy, Seizure history, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people quit smoking using repetitive transcranial magnetic stimulation (rTMS). This technique uses magnetic fields to target brain areas linked to addiction and cravings. The goal is to determine if rTMS can serve as a practical treatment for daily smokers and improve quit rates. Participants will attend 25-minute sessions over six weeks at the Center for Addiction and Mental Health in Toronto. Daily smokers without metal implants in their heads may be suitable for this trial. As a Phase 4 trial, the research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

You might need to stop taking certain medications. If you're on anticonvulsants or benzodiazepines, you may need to taper off unless it's unsafe to do so. It's best to discuss this with your doctor.

What is the safety track record for repetitive transcranial magnetic stimulation (rTMS)?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe. In a key study, participants received daily rTMS treatments for six weeks to reduce their urge to smoke. Most participants did not experience serious side effects. Some reported mild discomfort at the treatment site or headaches, but these issues were usually temporary.

Another study supports these findings, showing that rTMS for quitting smoking rarely causes serious problems. This treatment uses magnetic fields to stimulate specific brain areas to help control cravings and decision-making. It is non-invasive, meaning it doesn't involve surgery or needles.

Additionally, one rTMS device has received regulatory approval, indicating it meets certain safety standards. While no treatment is completely without risk, current evidence suggests that rTMS is a safe option for those looking to quit smoking. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to non-invasively stimulate specific areas of the brain linked to addiction, offering a fresh approach for those looking to quit smoking. Unlike traditional treatments such as nicotine replacement therapies or medications like varenicline and bupropion, which primarily address the chemical side of addiction, rTMS directly targets neural circuits involved in craving and withdrawal. Researchers are excited about rTMS because it offers a new mechanism of action that could potentially reduce cravings more effectively and with fewer side effects than current options.

What evidence suggests that rTMS is effective for helping people quit smoking?

Research shows that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial will receive, can help people quit smoking. Studies have found that rTMS reduces cravings and the number of cigarettes smoked each day. For example, one study found that rTMS significantly lowered cravings, as measured by a craving questionnaire. Another study showed that people who received rTMS smoked about seven fewer cigarettes per day compared to those who didn't receive the treatment. This treatment stimulates parts of the brain involved in craving and decision-making, which are important in overcoming addiction. ^{2 6 7 8 9}

Who Is on the Research Team?

Victor Tang, MD

Principal Investigator

Center for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for daily smokers who want to quit and are willing to attend treatment sessions at the Center for Addiction and Mental Health in Toronto. Participants must complete surveys and interviews, undergo 3 weeks of daily rTMS treatments followed by weekly sessions for another 3 weeks.

Inclusion Criteria

Smoking cigarettes daily (self-reported)

I am currently undergoing rTMS treatment.

Health care providers currently employed as a HCP (physician, social worker, occupational therapist, etc.) at the CAMH NDC and involved in the care of at least 1 patient who has received rTMS for smoking cessation

Exclusion Criteria

I am receiving rTMS and do not have any severe health, mental, or substance use issues.

There are no exclusion criteria for HCP Participants

I am undergoing rTMS and have no removable metal in or near my head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions

6 weeks

Daily visits for 3 weeks, then weekly visits for 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants' smoking cessation rates are evaluated through self-reported and biochemically verified methods

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests repetitive transcranial magnetic stimulation (rTMS) using Brainsway H4 deep rTMS coil and stimulator system on two brain regions linked to addiction cravings and decision-making. The aim is to assess if this non-invasive method can help smokers quit by stimulating these areas.

How Is the Trial Designed?

Group I: Patients Receiving rTMS Experimental Treatment 1 Intervention

Participants will receive 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks of treatment. Each session lasts about 25 minutes and is provided by an rTMS technician at the Temerty Center at 1025 Queen Street West, with medical supervision.

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

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has shown effectiveness in reducing cravings for tobacco, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC), based on a review of eight studies.

Repeated sessions of high-frequency rTMS over the DLPFC may be particularly beneficial for decreasing smoking and alcohol consumption, suggesting that rTMS could be a promising treatment option for drug addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. Barr, MS., Farzan, F., Wing, VC., et al.[2019]

In a study involving 35 male schizophrenia patients, high-frequency rTMS (10Hz) over the left dorsolateral prefrontal cortex significantly reduced cigarette consumption compared to a sham treatment, with effects observed as early as the first week of stimulation.

The treatment did not correlate with changes in negative or depressive symptoms of schizophrenia, suggesting that rTMS specifically targets smoking behavior rather than overall psychiatric symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. Prikryl, R., Ustohal, L., Kucerova, HP., et al.[2017]

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]

This study involves 258 adults motivated to quit smoking and aims to determine the optimal dosing strategy for high frequency repetitive transcranial magnetic stimulation (rTMS) to enhance long-term abstinence from smoking while minimizing side effects.

The research will assess various outcomes, including relapse rates and cognitive-behavioral skills, over a 6-month follow-up period, potentially paving the way for innovative treatments for tobacco dependence and other addictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial. Carl, E., Liskiewicz, A., Rivard, C., et al.[2021]

A pilot study involving 24 participants with severe nicotine dependence showed that 1 Hz repetitive transcranial magnetic stimulation (rTMS) over the left frontal pole significantly reduced craving responses to both smoking-related and neutral cues, indicating its potential efficacy in treating tobacco use disorder.

The study found a correlation between improved verbal memory recall and reduced reactivity to neutral cues, suggesting that rTMS may influence craving experiences through its effects on memory systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left frontal pole repetitive transcranial magnetic stimulation reduces cigarette cue-reactivity in correlation with verbal memory performance. Marques, RC., Marques, D., Vieira, L., et al.[2022]

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]

Citations

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

Repetitive transcranial magnetic stimulation for smoking ... Most research evaluating rTMS as a smoking cessation therapy has looked at the effect of targeting the dorsolateral prefrontal cortex using ...

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

Repetitive transcranial magnetic stimulation for smoking ... Many studies used a cue-induced craving paradigm with the rTMS treatments. Most of these studies showed positive effects on reducing craving or consumption, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34505368/

a pivotal multicenter double-blind randomized controlled trial This study establishes a safe treatment protocol that promotes smoking cessation by stimulating relevant brain circuits.

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

Efficacy of repetitive transcranial magnetic stimulation for ... rTMS demonstrated significant reductions in craving, as measured by the Tobacco Questionnaire for Smoking Urges (MD = -10.89, 95% CI [-12.94 to ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8429333/

Repetitive transcranial magnetic stimulation for smoking ... Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double‐blind randomized controlled trial

7. 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

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06346028?term=AREA%5BBasicSearch%5D(brainsway)&rank=7

Implementation of Transcranial Magnetic Stimulation for ... A landmark 2021 study showed that daily rTMS treatment for 6 weeks targeting these regions is effective at reducing craving and cigarette use. This study's ...

9. academic.oup.com academic.oup.com/braincomms/article/7/2/fcaf101/8052715

Repetitive transcranial magnetic stimulation reduces smoking ... This study aimed to examine the effectiveness of rTMS in smoking cessation and to explore the underlying neural mechanism of the treatment effect.