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

Trial Summary

What is the purpose of this trial?

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.

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

Research shows that rTMS can help people quit smoking by reducing cravings and cigarette consumption. In a large study, 19.4% of smokers who received active rTMS quit smoking for at least four weeks, compared to 8.7% who received a fake treatment. This suggests that rTMS can be an effective aid for smoking cessation. ^{1 2 3 4 5}

Is rTMS safe for smoking cessation?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans and has been used in various studies to help with smoking cessation. It is a non-invasive method that has been tested in multiple trials, including a large multicenter study, and has received clearance from the US Food and Drug Administration for use in adults trying to quit smoking. ^{1 4 6 7 8}

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

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain involved in addiction and craving, unlike traditional methods like nicotine replacement or medications. It has shown promise in reducing cigarette consumption and increasing quit rates by targeting brain circuits related to reward and executive control. ^{1 4 6 7 8}

Research Team

Christine Sheffer

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

I smoke 5-25 cigarettes daily and plan to quit within a month.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

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

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. Switzerland 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. [2022]

4. 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]

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

Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. [2022]

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. Germany pubmed.ncbi.nlm.nih.gov

[Transcranial magnetic stimulation for nicotine dependence]. [2014]

8. Germany pubmed.ncbi.nlm.nih.gov

[Repetitiv Transcranial Magnetic Stimulation in Nicotine Dependence] [2019]