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Tests treatment safety and results for Tobacco Use Disorder
Official title Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial
ClinicalTrials.gov ID: NCT06534047
What this study is testing
What is Nicotine replacement?
Nicotine replacement is an investigational medicine, given as an once-weekly inhaled treatment, being studied as a potential treatment for tobacco use disorder.
Also referred to as Treatment As Usual.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patient Participants: The patient participant must meet all the 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)...
You likely can't join 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...
- 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...
- Space occupying intracranial lesion.
See the full eligibility criteria
- Patient Participants: The patient participant must meet all the 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)...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.