Deep TMS to help adults with psychiatric conditions quit smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: victor.tang@camh.ca
• Phone: 416-535-8501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating the effects of propranolol and nicotine patches on smoking cues

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.