Deep TMS to help adults with psychiatric conditions quit smoking

Integrating Transcranial Magnetic Stimulation as a Treatment for Nicotine Dependence in the Clinic: A Pragmatic, Hybrid Effectiveness-Implementation Trial

This project will test whether deep transcranial magnetic stimulation (dTMS) helps adults with psychiatric disorders quit smoking better than usual nicotine replacement and counseling.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06534047 on ClinicalTrials.gov

What this trial studies

This randomized, pragmatic comparative-effectiveness pilot uses a type 1 hybrid effectiveness–implementation design to compare Brainsway deep rTMS (dTMS) versus treatment as usual (nicotine replacement therapy and counseling) for smoking cessation in people with psychiatric comorbidities. Eligible participants are age 18–70, smoke daily, meet DSM-5 criteria for a mood, anxiety, psychotic, PTSD, OCD, or other substance use disorder, and intend to quit within 30 days. The dTMS arm receives the FDA/Health Canada–cleared Brainsway H4 coil with three weeks of daily on-site sessions followed by three weeks of weekly sessions, while the TAU arm receives nicotine replacement and physician-supervised counseling. The trial is conducted at the Centre for Addiction and Mental Health in Toronto and pairs clinical outcomes with implementation measures to inform real-world delivery.

Who should consider this trial

Good fit: Ideal candidates are daily cigarette smokers aged 18–70 who meet DSM-5 criteria for a specified psychiatric disorder and are planning to quit within the next 30 days and are willing to try either dTMS or nicotine replacement.

Not a fit: People with contraindications to TMS (for example certain implanted metal devices or a history of seizures), those not intending to quit, non-daily smokers, or those unable to attend frequent on-site visits may not benefit from participation.

Why it matters

Potential benefit: If successful, dTMS could provide an effective non‑pharmacologic option to increase smoking quit rates in people with psychiatric disorders.

How similar studies have performed: Deep TMS has FDA clearance for tobacco use and prior trials showed efficacy for smoking cessation, though evidence specifically in populations with diverse psychiatric comorbidities is more limited.

Eligibility criteria

Inclusion Criteria:

Patient Participants:

The patient participant must meet all the inclusion criteria to be eligible for this study:

1. Able to provide informed consent.
2. Age 18-70.
3. Self-reported daily tobacco cigarette consumption.
4. Meet DSM-5 criteria for a psychiatric disorder that includes one of the following: mood disorders (e.g. major depressive disorder, bipolar disorder), anxiety disorders (e.g. panic disorder, social anxiety disorder), psychotic disorders (e.g. schizophrenia), posttraumatic stress disorder, obsessive compulsive disorders, or other substance use disorders (e.g. alcohol use disorder) as determined by the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5 RV).
5. Interested in using either Repetitive Transcranial Magnetic Stimulation (rTMS) or nicotine replacement therapy as a smoking cessation treatment.
6. Intending on quitting smoking within the next 30 days.

Exclusion Criteria:

Patient Participants:

1. Contraindication to rTMS according to the TMS Adult Safety Screen (TASS) and PI review.
2. Have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
3. Pregnant or intending to be pregnant during the study.
4. A history of a primary seizure disorder, seizure associated with an intracranial lesion, recurrent seizures related to substance intoxication or withdrawal or recent seizure within the last 6 months.
5. Space occupying intracranial lesion.
6. Any generalized skin disorders precluding the use of the nicotine patch.
7. Any known hypersensitivity or allergies to the nicotine patch.
8. Any known life-threatening arrhythmias or severe/worsening angina pectoris.
9. Within two weeks of experiencing a myocardial infarction or cerebral vascular accident.
10. Currently using or has used nicotine replacement therapy within the past two weeks.
11. Diagnosed with a terminal illness
12. Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop using these devices for the duration of the study.
13. Acutely unstable medical, psychiatric, or substance use disorder comorbidity with safety concerns at the discretion of the PI or study physician.
14. Previous treatment with rTMS for smoking cessation
15. Treatment with nicotine replacement therapy anytime within the last 1 month

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Victor M Tang, MD — Centre for Addiction and Mental Health
• Study coordinator: Victor M Tang, MD

Conditions Tobacco Use Disorder; Psychiatric Disorder; Nicotine Dependence; Repetitive Transcranial Magnetic Stimulation; Smoking Cessation