Status:
RECRUITING
Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Tobacco Use Disorder
Psychiatric Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited ...
Detailed Description
The objective is to pilot a pragmatic, randomized, comparative effectiveness trial of rTMS, compared to treatment as usual (TAU), for smoking cessation in individuals with psychiatric comorbidities, u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06534047
Start Date
September 1 2024
End Date
December 1 2026
Last Update
December 11 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada