Everything you need to know about TMS for Smoking Cessation: How Deep TMS Targets Nicotine Addiction — how it works, what it costs, and how to find a provider who actually knows what they're doing.
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Tobacco smoking remains the leading preventable cause of death in the United States, responsible for approximately 480,000 deaths annually. Despite widespread awareness of the health risks, approximately 28.3 million Americans continue to smoke, and the majority of those who attempt to quit will relapse within a week. Nicotine replacement therapy, varenicline (Chantix), bupropion (Wellbutrin), and behavioral counseling all have proven efficacy, but even in combination, they leave a substantial proportion of smokers unable to achieve lasting abstinence. The FDA clearance of deep transcranial magnetic stimulation (Deep TMS) for smoking cessation is a new approach — one that targets the neurobiological circuitry of addiction rather than addressing nicotine pharmacology alone.
What You’ll Learn
- How nicotine addiction affects the mesolimbic reward pathway and prefrontal cortex
- Why the insula is a key target for TMS in smoking cessation
- What the BrainsWay pivotal trial showed about quit rates
- How Deep TMS fits alongside medications like varenicline
- What the standard Deep TMS smoking cessation protocol looks like
The Neuroscience of Nicotine Addiction
Nicotine addiction is not simply a matter of habit or willpower — it is a chronic relapsing brain disorder with measurable neurobiological foundations.
When nicotine enters the brain, it binds to nicotinic acetylcholine receptors (nAChRs), triggering the release of dopamine in the mesolimbic reward pathway — the same neural circuitry activated by food, sex, and other natural rewards. The resulting dopamine surge in the nucleus accumbens (NAc) and ventral tegmental area (VTA) creates the subjective experience of pleasure and reward that reinforces smoking behavior.
Over time, with chronic nicotine exposure, the brain adapts:
- Dopamine receptor availability decreases, requiring more nicotine to achieve the same reward
- Cue-reactivity strengthens: Brain regions associated with conditioned reward (the hippocampus, amygdala, and orbitofrontal cortex) develop hyperactive responses to smoking-related cues (the smell of cigarettes, the feel of a pack, after a meal)
- Prefrontal regulatory function declines: The dorsolateral prefrontal cortex (dlPFC), responsible for decision-making and impulse control, becomes less effective at inhibiting smoking urges
This last change is critical: the prefrontal cortex normally allows us to weigh the long-term consequences of our actions against immediate impulses. When prefrontal function is compromised by chronic nicotine exposure, the brain’s reward systems override rational decision-making, perpetuating addiction.
Deep TMS for Smoking Cessation: The Science
Deep TMS for smoking cessation uses the BrainsWay H-coil system to stimulate deeper brain structures than standard TMS coils can reach. The primary targets are the dorsolateral prefrontal cortex (dlPFC) and the insula — a deep brain region that is critically involved in addiction.
The insula has emerged as a key structure in addiction neuroscience. It plays a central role in interoception (awareness of internal bodily states), craving, and decision-making related to substance use. Neuroimaging studies consistently show that the insula is hyperactive in smokers and that smoking cessation is associated with reduced insula activity. Damage to the insula (from strokes or injuries) has been associated with sudden, effortless smoking cessation — an observation that has profoundly influenced addiction neuroscience.
By targeting the insula and the prefrontal cortex with deep TMS, the treatment aims to:
- Reduce cravings by modulating insula activity
- Strengthen prefrontal regulatory function, enhancing the brain’s capacity to resist urges
- Disrupt the conditioned reward associations that make smoking cues so powerfully triggering
FDA Clearance and Clinical Evidence
In August 2020, the BrainsWay Deep TMS system (H4 coil) received FDA 510(k) clearance as a short-term aid for smoking cessation in adults (BrainsWay announcement). It was the first FDA clearance of a TMS device for an addiction indication.
The clearance was based on a randomized, double-blind, sham-controlled, multicenter trial of 262 adult smokers who had made repeated unsuccessful quit attempts (Zangen et al., World Psychiatry, 2021). Participants received 18 sessions of active or sham Deep TMS over six weeks: daily sessions for three weeks, then one session per week for three weeks. The primary outcome was the four-week continuous quit rate, confirmed by urine cotinine testing:
- Primary analysis (234 participants with at least one session and one follow-up assessment): 19.4% quit with active TMS vs. 8.7% with sham
- Completers only (168 participants who finished treatment and follow-up): 28.4% vs. 11.7%
The completers-only figures are higher because they exclude people who dropped out, so the primary-analysis numbers are the more conservative estimate. Trial results are for the tested protocol and do not guarantee an outcome for any individual (BrainsWay trial results).
There are no head-to-head trials of Deep TMS against varenicline or nicotine replacement, so the quit rates from different studies cannot be directly compared.
The Treatment Protocol
The standard Deep TMS protocol for smoking cessation involves:
- 18 treatment sessions over 6 weeks (daily for three weeks, then once weekly for three weeks)
- Each session lasts approximately 20 minutes
- The H4 coil targets the lateral prefrontal cortex and insula bilaterally
- Treatment is performed in an outpatient setting without anesthesia
Ask your clinician how TMS fits with any nicotine replacement or other cessation medication you are using, and with behavioral support.
Who Is a Candidate?
Deep TMS for smoking cessation is appropriate for:
- Adult smokers who have previously attempted to quit and relapsed
- Smokers who have not responded to or cannot tolerate medications such as varenicline or bupropion
- Smokers seeking a non-pharmacological adjunct to their quit attempt
- Individuals without contraindications to TMS (no epilepsy, no metal implants in the head, no active psychotic disorder)
It is important to note that TMS for smoking cessation requires genuine motivation to quit. Like all cessation methods, it works best when combined with behavioral counseling and genuine commitment to change.
Why TMS Matters for Addiction Treatment
The clearance of TMS for smoking cessation is a notable development in addiction medicine. For decades, treatment options were limited to medications targeting nicotine pharmacology and behavioral counseling. TMS introduces a third modality: direct neuromodulation of the brain circuits underlying addiction.
This approach is not specific to smoking. Researchers are actively investigating TMS for alcohol use disorder, cocaine addiction, opioid use disorder, and cannabis use disorder. While this research is still in early stages, the smoking cessation data are an early proof of concept for this approach.
For smokers who have tried everything and failed, Deep TMS offers an FDA-cleared option that targets the craving, reward, and regulatory circuits that have made quitting so difficult.
Frequently Asked Questions
Is TMS FDA-cleared for smoking cessation?
Yes. In August 2020, the BrainsWay Deep TMS system received FDA 510(k) clearance as a short-term aid for smoking cessation in adults. It was the first FDA clearance of a TMS device for an addiction indication.
How does Deep TMS compare to varenicline (Chantix)?
There are no head-to-head trials, so the two cannot be directly compared. In the pivotal trial, the four-week continuous quit rate was 19.4% with active Deep TMS vs. 8.7% with sham (28.4% vs. 11.7% among completers). Unlike medications, TMS does not introduce any substances into the body.
What does the Deep TMS smoking cessation protocol involve?
The protocol used in the pivotal trial was 18 sessions over 6 weeks: daily for three weeks, then once weekly for three weeks. Each session lasts about 20 minutes.
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