Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial

Recruiting now · Phase 4

Conditions studied: Tobacco Use Disorder, Psychiatric Disorder, Nicotine Dependence

In brief

Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Additionally, tobacco use is substantially higher in individuals with comorbid mental illness, constituting a particularly vulnerable population. As such, the development of multiple evidence-based treatments for smoking cessation is of upmost importance. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of substance use disorders. Recently, a deep TMS coil has been cleared by the Food and Drug Administration (FDA) as efficacious for tobacco use disorder, representing the first rTMS indication for addictions. Before adoption of this intervention into smoking cessation clinics, it is important to investigate whether implementation of rTMS into clinical care is feasible, acceptable, and appropriate for patients receiving care for nicotine dependence. The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation. Also, barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS.

Key facts

Study ID

NCT06534047

Run by

Centre for Addiction and Mental Health

People needed

40

Starts

2024-09-01

Expected to finish

2026-12-01

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient Participants:
• The patient participant must meet all the inclusion criteria to be eligible for this study:
• Able to provide informed consent.
• Age 18-70.
• Self-reported daily tobacco cigarette consumption.
• 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).
• Interested in using either Repetitive Transcranial Magnetic Stimulation (rTMS) or nicotine replacement therapy as a smoking cessation treatment.
• Intending on quitting smoking within the next 30 days.

You may not qualify if…

• Patient Participants:
• Contraindication to rTMS according to the TMS Adult Safety Screen (TASS) and PI review.
• 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.
• Pregnant or intending to be pregnant during the study.
• 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.
• Space occupying intracranial lesion.
• Any generalized skin disorders precluding the use of the nicotine patch.
• Any known hypersensitivity or allergies to the nicotine patch.
• Any known life-threatening arrhythmias or severe/worsening angina pectoris.
• Within two weeks of experiencing a myocardial infarction or cerebral vascular accident.
• Currently using or has used nicotine replacement therapy within the past two weeks.
• Diagnosed with a terminal illness
• 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.
• Acutely unstable medical, psychiatric, or substance use disorder comorbidity with safety concerns at the discretion of the PI or study physician.
• Previous treatment with rTMS for smoking cessation
• Treatment with nicotine replacement therapy anytime within the last 1 month

Where it is running

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

Full record on ClinicalTrials.gov

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