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Behavioural Intervention
Transcranial Magnetic Stimulation for Smoking
Phase 4
Recruiting
Led By Victor Tang, MD, MSc
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to see if using repetitive transcranial magnetic stimulation (rTMS) can help people quit smoking. rTMS uses a magnetic field to stimulate specific areas of the brain involved in
Who is the study for?
This trial is for daily smokers who want to quit and are willing to attend treatment sessions at the Center for Addiction and Mental Health in Toronto. Participants must complete surveys and interviews, undergo 3 weeks of daily rTMS treatments followed by weekly sessions for another 3 weeks.
What is being tested?
The study tests repetitive transcranial magnetic stimulation (rTMS) using Brainsway H4 deep rTMS coil and stimulator system on two brain regions linked to addiction cravings and decision-making. The aim is to assess if this non-invasive method can help smokers quit by stimulating these areas.
What are the potential side effects?
Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. Most people tolerate it well with minimal discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach.
Identify rates of adoption of rTMS in Nicotine Dependence Clinic
The primary objective of the study is to evaluate the feasibility of implementing rTMS in the Nicotine Dependence Clinic (NDC) at CAMH, in Toronto. This is determine by reach, the extent to which patients are engaging in the rTMS treatment.
Secondary study objectives
Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC.
Explore patient-HCP communication about shared treatment decision-making for rTMS.
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients Receiving rTMSExperimental Treatment1 Intervention
Participants will receive 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks of treatment. Each session lasts about 25 minutes and is provided by an rTMS technician at the Temerty Center at 1025 Queen Street West, with medical supervision.
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Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
82,651 Total Patients Enrolled
6 Trials studying Smoking
9,817 Patients Enrolled for Smoking
Victor Tang, MD, MScPrincipal InvestigatorCenter for Addiction and Mental Health