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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

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.

Do I qualify?Apply below to find out