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

Trial Summary

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 data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for smoking cessation?

Research shows that rTMS can help reduce tobacco cravings and increase quit rates among smokers. In a large study, smokers who received rTMS had a higher quit rate compared to those who received a fake treatment, and they also experienced a greater reduction in cigarette consumption and cravings. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans, as it has been used in various studies for smoking cessation and other conditions without significant safety concerns. ^{1 2 3 6 7}

How does the treatment rTMS differ from other treatments for smoking cessation?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it is a non-invasive brain stimulation technique that targets specific brain areas involved in addiction, such as the prefrontal cortex, to reduce cravings and cigarette consumption. Unlike traditional methods like nicotine replacement therapy, rTMS directly influences brain activity and connectivity, offering a novel approach to smoking cessation. ^{1 2 3 7 8}

What is the purpose of this trial?

Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively. The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada. Participants will be asked to come to CAMH to: * Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment * Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision. Objectives • Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health.

Research Team

Victor Tang, MD

Principal Investigator

Center for Addiction and Mental Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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 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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Left frontal pole repetitive transcranial magnetic stimulation reduces cigarette cue-reactivity in correlation with verbal memory performance. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. [2017]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. [2022]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. [2019]