dTMS for Smoking Cessation in Schizophrenia

Overseen By Scott J Moeller, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Stony Brook University

Must not be taking: Smoking cessation products, Clozapine

Disqualifiers: Substance use disorder, Epilepsy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 3 weeks

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brain stimulation treatment called deep transcranial magnetic stimulation (dTMS) to help people with schizophrenia reduce or quit smoking. The study aims to understand how this therapy affects brain connections and smoking habits. Participants will receive either the actual treatment or a sham version to compare results. Individuals with schizophrenia who smoke daily and wish to cut down or quit might be suitable for this trial.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance smoking cessation strategies for individuals with schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've changed your schizophrenia medication in the last 4 weeks. Also, you cannot use smoking cessation medications during the study.

What prior data suggests that dTMS is safe for smoking cessation in schizophrenia?

Research has shown that deep transcranial magnetic stimulation (dTMS) is generally safe for helping people quit smoking. Studies have found that dTMS can reduce cigarette consumption without causing serious side effects. In one study, dTMS proved more effective than a placebo in helping people stop smoking.

Participants who received dTMS reported no major health problems, indicating that the treatment is well-tolerated. dTMS works by sending magnetic pulses to specific brain areas, which can help reduce cravings. Overall, dTMS appears to be a promising and safe option for quitting smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for smoking cessation in individuals with schizophrenia involve medications like nicotine replacement therapies, varenicline, or bupropion. However, deep transcranial magnetic stimulation (dTMS) stands out because it uses magnetic fields to stimulate nerve cells in the brain, offering a non-drug-based approach. What's exciting about dTMS is its potential to target specific brain regions involved in addiction, which might make it more effective or suitable for individuals who struggle with medication side effects. Moreover, it provides a new avenue for treatment that could complement existing therapies, possibly enhancing overall success rates in quitting smoking.

What evidence suggests that dTMS is effective for smoking cessation in schizophrenia?

Research shows that deep transcranial magnetic stimulation (dTMS) can help reduce the urge to smoke in people with schizophrenia. This trial will provide participants with either active dTMS or a sham version to evaluate its effectiveness. Studies have shown that people with schizophrenia smoked less and relied less on nicotine after receiving dTMS. Previous research found that transcranial magnetic stimulation (TMS) can help treat nicotine addiction. Although researchers are still studying dTMS, early results are promising for those who want to quit smoking, especially in this vulnerable group. The treatment is generally safe, with only mild side effects like headaches reported. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-60 with schizophrenia or related conditions who smoke daily and want to reduce or quit. They must be able to consent, have a negative drug test (except for cannabis), and meet DSM-5 criteria for nicotine use disorder.

Inclusion Criteria

I understand the information given to me and can make decisions about my health care.

I have been diagnosed with a schizophrenia spectrum disorder.

Negative urine toxicology (other than cannabis) maintained throughout study participation

Exclusion Criteria

I am currently using products to help me stop smoking.

Contraindications to dTMS*

Contraindications to MRI or PET

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deep repetitive transcranial magnetic stimulation (dTMS) for 5 days a week over 3 weeks

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for changes in insula synaptic density and smoking behavior post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active deep transcranial magnetic stimulation (dTMS)
• Sham dTMS

Trial Overview The study tests if deep transcranial magnetic stimulation (dTMS) affects synaptic density in the brain's insula region, measured by PET scans, and if it influences smoking behavior in schizophrenia patients.

How Is the Trial Designed?

Group I: Active deep transcranial magnetic stimulation (dTMS) Experimental Treatment 1 Intervention

Each treatment consists of 60 trains, each lasting 3 sec and interleaved with a 15 sec delay. The entire treatment is delivered over 20 min. The treatment goes for 5 days/week and for a total of 3 weeks.

Group II: Sham Placebo Group 1 Intervention

Active and sham cards do not differ in appearance, and both coils are enclosed within the same helmet, enabling double-blind administration. The same procedure will be done, the only difference is that the sham card does not deliver any stimulation.

Active deep transcranial magnetic stimulation (dTMS) is already approved in European Union, United States for the following indications:

Approved in European Union as Deep TMS for:

• Negative symptoms of schizophrenia

Approved in United States as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Smoking cessation

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving 29 smokers, 8 sessions of 20Hz rTMS targeting the left dorsolateral prefrontal cortex significantly reduced delay discounting rates and decreased the risk of relapse by three-fold, indicating its potential efficacy in smoking cessation.

Participants receiving active rTMS had a higher abstinence rate of 50% compared to 15.4% in the sham group, suggesting that this treatment combined with a self-help intervention is both feasible and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing relapse to smoking with transcranial magnetic stimulation: Feasibility and potential efficacy. Sheffer, CE., Bickel, WK., Brandon, TH., et al.[2022]

In a study involving 13 smokers with schizophrenia and 14 non-psychiatric controls, high-frequency repetitive transcranial magnetic stimulation (rTMS) did not significantly reduce tobacco craving or improve cognitive function after a short-term treatment period.

Despite the lack of efficacy in modifying craving and cognitive outcomes, the study found that rTMS was safe, with no significant adverse events reported, suggesting that further long-term studies are needed to explore its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Kozak, K., Sharif-Razi, M., Morozova, M., et al.[2021]

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]

A study involving 20 patients with schizophrenia showed that bilateral deep repetitive transcranial magnetic stimulation (dTMS) significantly delayed the initiation of smoking compared to a sham treatment, indicating its potential to disrupt tobacco self-administration.

Imaging results suggested that active dTMS led to decreased blood flow in the insula and changes in brain connectivity, hinting at its mechanism of action and possible therapeutic effects on psychotic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep rTMS of the insula and prefrontal cortex in smokers with schizophrenia: Proof-of-concept study. Moeller, SJ., Gil, R., Weinstein, JJ., et al.[2022]

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]

In a preliminary study involving 24 outpatients with schizophrenia and cannabis use disorder, high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the dorsolateral prefrontal cortex was found to be safe and well-tolerated, with a high retention rate of about 90%.

The active rTMS group showed a trend towards reduced cannabis use and craving, along with significant improvements in psychiatric symptoms and attention, suggesting that rTMS may be an effective treatment option for cannabis use disorder in patients with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating repetitive transcranial magnetic stimulation on cannabis use and cognition in people with schizophrenia. Bidzinski, KK., Lowe, DJE., Sanches, M., et al.[2022]

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]

High dose transcranial magnetic stimulation (rTMS) at 10 Hz significantly reduced negative symptoms in schizophrenia patients, particularly blunted affect, emotional withdrawal, and passive/apathetic social withdrawal, with an effective rate of 43.75% compared to 11.43% in the control group.

While rTMS was found to be effective, it was associated with a higher incidence of headaches (37.50% in the study group) compared to the control group, indicating a need for monitoring side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of high dose transcranial magnetic stimulation in schizophrenia with refractory negative symptoms: a randomized controlled study]. Gan, J., Duan, H., Chen, Z., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8429333/

Repetitive transcranial magnetic stimulation for smoking ... High frequency repetitive transcranial magnetic stimulation reduces tobacco craving in schizophrenia. Schizophr Res 2012;1:264‐6. [DOI] ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834325001070

Effectiveness and safety of repeated transcranial magnetic ... People with schizophrenia were more likely to reduce smoking and nicotine dependence. Adverse reactions were mild, with only the incidence of headache being ...

3. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-025-00558-2

Efficacy of repetitive transcranial magnetic stimulation for ... ... stimulation to test alternative causal pathways for nicotine addiction in schizophrenia. ... deep TMS really works for smoking cessation? A ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0925492725001325

a regional homogeneity study based on resting-state fMRI Previous studies have demonstrated the efficacy of transcranial magnetic stimulation (TMS) on treating nicotine addiction. ... schizophrenia ( ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1653926/full

a pilot study by diffusion spectrum imaging ... rTMS in the treatment of smokers without psychosis has not ... stimulation to test alternative causal pathways for nicotine addiction in schizophrenia.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02126124

NCT02126124 | Evaluation of Deep Transcranial Magnetic ... The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham treatment as an aid to smoking cessation in chronic, heavy (>10 ...

7. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-025-00503-3

Efficacy and safety of repetitive transcranial magnetic ... This study aimed to assess the effectiveness of active r-TMS in reducing smoking behavior, withdrawal symptoms, cravings, and nicotine dependence

8. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.920383/full

Transcranial Magnetic Stimulation for Long-Term Smoking ... Repetitive transcranial magnetic stimulation (rTMS) is a novel treatment for smoking cessation and delay discounting rate is novel therapeutic target.