Deep TMS is FDA-cleared as a short-term aid to smoking cessation for adults. The protocol is 15 sessions over three weeks plus three weekly maintenance sessions, using the H4 coil over the prefrontal cortex and insula, with a brief smoking cue exposure before each session. In the pivotal trial, four-week continuous abstinence was about 28 percent with active treatment versus 12 percent with sham.
Smoking cessation is a different kind of TMS treatment from depression: a shorter course, a different coil, a cue-exposure step before each session, and an outcome measured in cigarettes rather than mood scores. This page explains the protocol, the evidence, the realistic expectations, and how it fits alongside nicotine replacement, varenicline and counseling at our Palm Beach Gardens office.
Who it is for
Candidates are adults who smoke, want to quit, and have either tried and failed with standard approaches such as nicotine replacement, varenicline or bupropion, or cannot use them. The trial enrolled people smoking at least 10 cigarettes a day who had made at least one prior quit attempt. People with depression who also smoke are a natural fit, since smoking rates in depression are roughly double the general population and quitting is harder when mood is low. People who use nicotine in other forms, such as vaping or smokeless tobacco, are outside the cleared indication, though the mechanism is the same. Contraindications are the standard TMS ones: metal in the head, implanted devices and seizure history, with particular attention to bupropion dose, since bupropion lowers the seizure threshold.
How it works
Nicotine addiction involves the insula, which processes craving and bodily urges, and the prefrontal cortex, which exerts control over impulses. The smoking cessation protocol uses the H4 coil, designed to stimulate the bilateral prefrontal cortex and insula at once, at 10 Hz and 120 percent of motor threshold. Before each session, you are exposed to smoking cues for a few minutes: handling a cigarette, viewing images, or recalling a smoking situation, to activate the craving circuit. Stimulation then follows, on the same principle used in the OCD protocol: the circuit changes most readily while it is engaged. The intent is to reduce craving and strengthen the prefrontal control that lets you decline a cigarette when the urge arrives.
In the pivotal multicenter trial of 262 smokers, four-week continuous abstinence was 28 percent with active Deep TMS versus 12 percent with sham, and the active group reduced cigarettes per day significantly more.
Source: Zangen et al., World Psychiatry, 2021
The FDA cleared Deep TMS as a short-term aid to smoking cessation in August 2020, the first clearance of any TMS device for an addiction indication.
Source: FDA 510(k) K200957, 2020
Fewer than 10 percent of smokers who try to quit without assistance are abstinent at one year; varenicline roughly triples the odds of quitting compared with placebo.
Source: Cahill et al., Cochrane Database of Systematic Reviews, 2016; CDC
Adults with depression smoke at roughly twice the rate of adults without depression, and are less likely to succeed in quit attempts.
Source: CDC National Health Interview Survey; Lasser et al., JAMA, 2000
What to expect
The course is 15 daily sessions over three weeks, then one session a week for three weeks, 18 sessions in total. Each session takes about 20 minutes including cue exposure. You set a quit date, usually at the end of week one, and we track cigarettes per day and carbon monoxide breath readings at each visit. Cravings typically decline through weeks two and three. The maintenance sessions in weeks four through six cover the period when most relapses happen. We strongly recommend combining TMS with counseling and, where appropriate, nicotine replacement, since the combination performs better than any single method.
Benefits
- The only FDA-cleared brain stimulation treatment for an addiction
- Roughly doubles continuous abstinence compared with sham in the pivotal trial
- Short course: 18 sessions over six weeks
- No drug, so no interaction with nicotine replacement or other medication
- Addresses craving directly, which is where most quit attempts fail
Risks and side effects
Side effects are the same as other Deep TMS protocols: scalp discomfort and headache in the first week, facial twitching during pulses, and rare seizure risk under 0.1 percent per course. The cue-exposure step temporarily increases craving by design, and some patients find the first few sessions frustrating for that reason. Seizure risk requires attention to bupropion, which is commonly prescribed for smoking cessation and lowers the seizure threshold; we review the dose before starting. No cognitive or systemic effects.
Cost and insurance
Smoking cessation is not currently a covered TMS indication under Medicare or most commercial plans, which treat the 2020 clearance as too recent for a coverage policy. Most patients who choose TMS for smoking are self-pay. Ask our TMS coordinator for current self-pay rates for the 18-session smoking protocol. Health savings and flexible spending accounts may be used. If you also have treatment-resistant depression, a covered depression course may be the more practical path, and reductions in smoking are a common secondary benefit.
The trial behind the clearance
The evidence comes from a multicenter, double-blind, sham-controlled trial published in World Psychiatry in 2021 by Abraham Zangen and colleagues. It enrolled 262 adults who smoked at least 10 cigarettes a day and had failed at least one prior quit attempt, at 14 sites in the United States and Israel. Participants received 15 daily sessions of active or sham Deep TMS with the H4 coil over three weeks, then weekly sessions for three weeks, each preceded by a brief cue-provocation procedure. The primary outcome was four-week continuous quit rate, verified by urine cotinine. Active treatment produced a 28 percent quit rate versus 12 percent for sham in participants who completed the protocol, and cigarettes per day fell significantly more in the active group. Side effects were the usual headache and scalp discomfort, with no serious adverse events attributed to the device.
How it compares with standard quit aids
| Approach | Typical effect | How it works | Covered by insurance? |
|---|---|---|---|
| Unassisted quit attempt | About 5 to 7 percent abstinent at 6 to 12 months | Willpower | Not applicable |
| Nicotine replacement (patch, gum, lozenge) | Roughly 1.5 to 2 times unassisted | Replaces nicotine, eases withdrawal | Usually |
| Bupropion | Roughly 1.6 times unassisted | Dopamine and norepinephrine; reduces craving | Usually |
| Varenicline | Roughly 2 to 3 times unassisted | Partial nicotine receptor agonist; blunts reward | Usually |
| Counseling | Roughly 1.5 times unassisted; additive to medication | Skills, planning, support | Usually |
| Deep TMS (H4 protocol) | About 2.3 times sham at 4 weeks in the pivotal trial | Stimulates prefrontal cortex and insula during cue exposure | Not currently |
The honest reading of this table is that TMS is in the same range as the best medication, not dramatically better, and that it works through a different pathway, so adding it to medication and counseling is reasonable. Trial participants were allowed to use other aids, and the effect was seen on top of them.
The protocol step by step
- Consultation: a Stedfast psychiatrist confirms nicotine dependence, reviews prior quit attempts and medications, screens for TMS contraindications, and sets a quit date, typically at the end of week one.
- Day one: motor threshold mapping with the H4 coil, baseline carbon monoxide breath reading, and development of your cue-exposure script.
- Weeks one through three: daily sessions, Monday through Friday. Each begins with three to five minutes of cue exposure (handling an unlit cigarette, viewing smoking images, recalling a typical smoking moment), followed by about 18 minutes of stimulation. Cigarettes per day and CO readings are recorded.
- Weeks four through six: one session a week, covering the period when most relapses occur.
- Follow-up: a visit at three months to review abstinence and adjust medication or counseling.
Smoking and depression together
About a third of people with depression smoke, roughly twice the rate in the general population, and they are less likely to succeed when they try to quit. Nicotine temporarily improves mood and concentration, which makes it a form of self-medication that is hard to give up while depressed. For patients who have both treatment-resistant depression and nicotine dependence, we usually recommend treating the depression first with a covered Deep TMS course. Many patients spontaneously cut down or quit as their mood improves, and those who do not can then consider the smoking protocol with a better chance of success.
What to combine with TMS
Counseling, whether through the Florida Quitline at 1-877-822-6669, a Stedfast therapist, or a structured group program, adds measurably to every pharmacological and device-based approach. Nicotine replacement can be used throughout. Varenicline can be started a week before the quit date and continued for three months. Bupropion is acceptable with dose review. The strongest plan is TMS plus one medication plus counseling, with a defined quit date in week one of the course.
Deep TMS in Palm Beach Gardens
Stedfast Psychiatry delivers Deep TMS at our Palm Beach Gardens office, 11641 Kew Gardens Ave, Suite 209, just off PGA Boulevard and I-95. Patients travel to us from Jupiter, West Palm Beach, Boynton Beach, Stuart and Royal Palm Beach, and most find the drive manageable because a Deep TMS session takes about 20 minutes and you drive yourself home. Call (561) 437-2199 to schedule a TMS consultation, or ask your current Stedfast provider for an internal referral. Our TMS coordinator handles insurance verification, prior authorization and scheduling so you can start as soon as approval comes through.
Frequently asked questions
Does TMS help you quit smoking?
It helps a meaningful share of people. In the trial that led to clearance, 28 percent of patients receiving active Deep TMS stayed continuously abstinent for four weeks versus 12 percent with sham, and the active group cut cigarettes per day by more. Those are not cure rates, and smoking is a hard addiction, but the effect is comparable to leading medications and it adds to them rather than competing. Combining TMS with counseling and nicotine replacement gives the best odds.
How many sessions does the smoking protocol take?
Eighteen in total: 15 daily sessions over three weeks, then one session a week for three more weeks. Each session is about 20 minutes including a few minutes of smoking cue exposure before stimulation. It is shorter than the depression course because the pivotal trial used this schedule and the clearance follows it. Some clinics offer additional maintenance sessions for patients who relapse; we discuss that case by case.
Is the smoking coil different from the depression coil?
Yes. The smoking protocol uses the H4 coil, which stimulates the prefrontal cortex on both sides and the insula, a deeper region involved in craving. The depression protocol uses the H1 coil over the left prefrontal cortex. The intensity and frequency also differ. If you have both depression and nicotine dependence, your psychiatrist will advise which protocol to run first; depression improvement often reduces smoking on its own.
Can I use nicotine patches or varenicline during TMS?
Yes, and we recommend it. TMS is a device, so there is no interaction with nicotine replacement, varenicline or counseling, and the trial allowed participants to use these aids. The one medication that needs review is bupropion, which lowers the seizure threshold; doses up to 300 mg daily are generally acceptable with monitoring, and higher doses may need to be reduced during the course.
Does insurance cover TMS for smoking?
Not at present. Medicare and commercial insurers have not adopted coverage policies for the 2020 clearance, so this is a self-pay treatment. Ask our TMS coordinator for current self-pay rates. Insurance does cover counseling, nicotine replacement, varenicline and bupropion, and we encourage combining those with TMS. If you also have treatment-resistant depression, a covered depression course may be the more practical starting point.
Does TMS work for vaping or other nicotine?
The clearance covers cigarette smoking specifically, because that is what the trial studied. The mechanism, reducing craving and strengthening prefrontal control, applies to nicotine in any form, and the cue exposure can be adapted to vaping. We will discuss it with you honestly as an off-label use with less direct evidence. There is no insurance coverage for it in any case.
What happens if I relapse after the course?
Relapse is common with any smoking treatment, and it is not failure. The weekly maintenance sessions in weeks four through six are designed to cover the highest-risk period. If you relapse later, a short booster course can be arranged, and we revisit the combination of counseling and medication. Many people quit for good on their third or fourth serious attempt, and each attempt with a stronger toolkit improves the odds.
Where this treatment is offered
Conditions this treats
If you are in crisis, call or text 988 or go to the nearest emergency room. Educational content; individual results vary. Reviewed by Dr. David Husted, board-certified psychiatrist.