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

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called repetitive transcranial magnetic stimulation (rTMS) to help people with psychiatric disorders quit smoking. Smoking is a major health issue, especially for those with mental health conditions, and current treatments often aren’t very effective. rTMS is a non-invasive technique that uses magnetic fields to stimulate the brain and may help people reduce their dependence on nicotine. The trial will compare how well rTMS works for helping patients quit smoking compared to standard treatments. Researchers will also talk to patients and healthcare providers to understand how well this new treatment can be integrated into regular care.

To participate in the trial, you need to be between 18 and 70 years old, smoke cigarettes daily, and have a diagnosed psychiatric disorder, such as depression or anxiety. You should be planning to quit smoking within the next month and be open to trying either rTMS or nicotine replacement therapy, like patches. If you have certain medical conditions or have had specific treatments recently, you might not be eligible. Participants can expect close support throughout the trial as they work towards quitting smoking, and this research could lead to new, more effective treatments for tobacco dependence in individuals with mental health challenges.

Gender

ALL

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