One TMS protocol is FDA-cleared to help adults quit smoking: BrainsWay's deep TMS system, cleared in 2020 and now labeled "as an aid in short-term smoking cessation for adults." It is a separate protocol from TMS for depression, with a different coil, a different brain target and a short craving exercise before every session. In the trial behind the clearance, about 1 in 5 people who started active treatment achieved four straight weeks without smoking, compared with fewer than 1 in 10 on sham.
That is a real effect, and also a reminder that most people in the trial were still smoking. Below is how the protocol works, what the numbers mean, and how it fits with the quit-smoking treatments that come first.
How the smoking-cessation protocol works
The cleared protocol comes from a large multicenter trial published in 2021. Participants had three weeks of daily sessions on weekdays, followed by three weeks of once-weekly sessions. That adds up to about 18 sessions over six weeks, far fewer than a typical depression course.
A few features set it apart:
- A different coil and target. The trial used an H4 deep TMS coil aimed at the lateral prefrontal cortex and insula on both sides, regions tied to craving and decision-making.
- Cue exposure before each session. Every session started with a 5-minute craving procedure: imagining your strongest trigger to smoke and looking at pictures of smoking. The idea is to activate the craving circuit just before stimulation.
- Dose set by your motor threshold. As in depression treatment, the team first finds the strength that makes your hand twitch, then treats at a set percentage of it; the trial used 120% of motor threshold and 1,800 pulses per session at 10 Hz. Our page on the first session and motor threshold explains that step.
The craving exercise is similar in spirit to the symptom-provocation step used in deep TMS for OCD, described in TMS for OCD.
What the pivotal trial found
The trial enrolled 262 chronic smokers who had failed at least one earlier quit attempt; 68% had failed at least three times. The main result used a strict definition: four weeks of continuous abstinence up to week 18, confirmed by daily smoking diaries and urine cotinine tests (a nicotine breakdown product).
| Group analyzed | Active TMS | Sham TMS | What it means |
|---|---|---|---|
| Everyone in the efficacy set (234 people) | 19.4% quit for 4 straight weeks | 8.7% | The fairest estimate: includes people who dropped out |
| Completers only (169 people) | 28.0% | 11.7% | Higher because people who left early are excluded |
Cigarette use and craving also fell more with active treatment, starting about two weeks in. Dropout by week 6 was high in both groups, 39% with active and 32% with sham treatment. That matters: a protocol only helps if you can keep coming.
So the honest reading is that deep TMS roughly doubled the quit rate compared with sham in a hard-to-treat group, while most participants did not reach the abstinence goal. There is one pivotal trial, so longer-term results are not yet well established.
Who the protocol was tested in
The label is for adults, and the trial's entry rules tell you who the evidence really covers. Participants were 22 to 70 years old and had smoked at least ten cigarettes a day for at least a year. People were excluded if they were already in treatment for smoking, used nicotine in forms other than cigarettes, had another active psychiatric disorder or a substance use disorder in the past year, took psychotropic medication regularly, or had a history of seizures or epilepsy.
Those exclusions matter in real life. Many people who smoke also take antidepressants or other psychiatric medications, or vape alongside cigarettes. The trial does not tell us how well the protocol works for them. A TMS psychiatrist can still consider it, but with less evidence to lean on, and it is reasonable to ask how they would judge whether it is helping you.
The usual TMS safety screen applies too: no conductive or ferromagnetic metal implanted in or near the head, and a careful look at seizure risk factors. See am I a candidate for TMS for the full checklist.
Start with the proven quit-smoking treatments
For most adults, TMS is not the first step. The U.S. Preventive Services Task Force recommends that clinicians offer adults who smoke both behavioral support and FDA-approved medication, and names nicotine replacement therapy, bupropion SR and varenicline as the approved medications. It also notes that combining counseling with medication raises quit rates. Those treatments are cheaper, widely covered and easier to reach than daily clinic visits.
TMS starts to make more sense when you have tried those approaches seriously and still relapsed, or when a medication caused side effects you could not live with.
| Approach | Status | Practical notes |
|---|---|---|
| Counseling plus FDA-approved medication | First-line recommendation for adults | Quitlines, primary care or a psychiatrist can start it |
| Deep TMS smoking protocol | FDA-cleared aid for short-term cessation in adults | About 18 visits over 6 weeks; one pivotal trial |
| Standard TMS for depression | Cleared for depression, not for smoking | Different target and schedule; treats mood, not nicotine dependence |
Combining TMS with nicotine replacement or medication
This is where the evidence runs thin. The pivotal trial excluded people already in smoking treatment, so it did not test TMS alongside nicotine patches, varenicline or bupropion. No one can tell you from that trial whether combining them adds benefit.
In practice, the decision belongs to you and your prescriber. Some points to discuss:
- Every medication you take is part of TMS safety screening, because some drugs and situations affect seizure threshold. FDA guidance asks for close monitoring of people on drugs known to lower it. Our page on medications during TMS explains how teams review this.
- Alcohol withdrawal and heavy drinking are recognized seizure risk factors, so tell the team honestly about alcohol use.
- Behavioral support costs nothing to add and is part of every recommended quit plan.
Side effects
In the smoking trial, headache was the most common adverse event, reported by 24.4% with active treatment and 18.0% with sham. One serious event, tinnitus that resolved, was judged possibly related to treatment.
Seizure is rare with TMS in general. One survey found a higher relative seizure rate with the deep TMS H-coil than with figure-8 coils, though the absolute risk was still low. Hearing protection is required during every session. The broader picture is on TMS side effects.
What the six weeks look like in practice
The first visit is longer than the rest, because the team has to find your motor threshold and position the coil before any treatment starts. After that, each weekday visit in the first three weeks follows the same rhythm: check in, the short craving exercise, then stimulation with earplugs in. You stay awake and alert, and you can go straight back to work or home afterward, since there is no sedation.
Weeks four to six drop to one visit a week. This is the stretch where many quit attempts wobble, so it helps to have your support in place before the daily visits end:
- Pick a quit date with your clinician rather than leaving it vague. The trial's main outcome counted abstinence in the weeks after treatment, so the quit itself is the goal, not just less craving.
- Line up a quitline or counselor for the weeks after treatment ends.
- Plan for your known triggers: the morning coffee, the commute, alcohol, stress at work.
- Decide in advance what you will do after a slip. One cigarette is not a failed course; tell the team and keep going.
Logistics matter as much as the science. Fifteen weekday visits in three weeks is manageable for some schedules and impossible for others; our guide to working and driving during a TMS course covers planning around a job.
Questions to ask before you sign up
- Do you use the cleared deep TMS smoking protocol, or a different, off-label approach?
- How do you run the craving exercise before each session?
- What counseling or follow-up do you offer during and after the six weeks?
- Can I use nicotine replacement or a quit medication at the same time, and how would that change my safety screening?
- What will the full course cost if my plan does not cover it?
A clinic offering a standard depression protocol "for smoking", or promising a quit rate, is not describing the cleared approach.
Cost, coverage and where to go next
Insurance coverage for TMS is built mostly around depression. Coverage for the smoking indication is much less established, so expect to check with your plan directly and to ask about self-pay costs. Does insurance cover TMS and TMS cost without insurance explain what to ask.
If you smoke and also live with depression, the conversation may be about TMS for depression rather than for smoking. For research on TMS in other addictions, see the physician's guide to TMS for addiction. Our addiction treatment page covers therapy-based support, the TMS guide has every related topic, and TMS therapy is where to start a conversation about your own situation.
Sources
- 510(k) K200957 and K203616 - BrainsWay Deep TMS System, aid in short-term smoking cessation. U.S. Food and Drug Administration, 2021. accessdata.fda.gov
- Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry, 2021. pmc.ncbi.nlm.nih.gov
- Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions. U.S. Preventive Services Task Force, 2021. uspreventiveservicestaskforce.org
- Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems. U.S. Food and Drug Administration, 2011. fda.gov
- Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clinical Neurophysiology, 2021. europepmc.org
- Seizure risk with repetitive TMS: Survey results from over a half-million treatment sessions. Brain Stimulation, 2021. europepmc.org
- 510(k) K160703 - NeuroStar TMS Therapy System. U.S. Food and Drug Administration, 2016. accessdata.fda.gov
FAQs
Is TMS for smoking FDA-approved?
It is FDA-cleared, which is the correct term for devices. One deep TMS system is cleared as an aid in short-term smoking cessation for adults. See is TMS FDA-approved for the difference.
Will a regular depression TMS course help me quit smoking?
It is not designed or cleared for that. The smoking protocol uses a different coil, a different brain target and a craving exercise before each session.
Does TMS work for vaping?
The pivotal trial studied cigarette smokers and excluded people using nicotine in other forms, so there is no direct evidence for vaping yet.
Does it hurt?
Most people feel tapping on the scalp, and headache was common in the trial. Read what TMS feels like for a session-by-session picture.
How long do the results last?
The trial followed people to week 18. Longer-term relapse rates after the protocol are not well established, so a relapse-prevention plan with counseling is wise.
