Implementation of Transcranial Magnetic Stimulation for Smoking Cessation

March 28, 2024 updated by: Centre for Addiction and Mental Health

A Pragmatic Feasibility Trial on the Implementation of Transcranial Magnetic Stimulation for Smoking Cessation

Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.

The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.

Participants will be asked to come to CAMH to:

  • Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment
  • Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.

Objectives

• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 45,000 Canadians die from smoking each year and smoking is the leading preventable cause of death worldwide. Quitting smoking is difficult, and current treatments such as varenicline and nicotine replacement therapy are not always able to help people quit.

Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.

A landmark 2021 study showed that daily rTMS treatment for 6 weeks targeting these regions is effective at reducing craving and cigarette use. This study's findings provided supporting evidence that led Health Canada and the Food and Drug Administration to approve rTMS as a treatment for smoking cessation. Currently, this treatment is not widely available, therefore it is important to learn more about how to bring it into clinics and develop it further.

The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.

The main questions it aims to answer are:

  • How many people who are patients at the NDC are interested in this treatment?
  • How acceptable is this treatment for people who have experienced it?
  • What factors of this treatment are appealing or unappealing to people?
  • How well does it work to help people quit smoking?
  • Who are the main group of people who want this treatment?

Participants will be asked to come to CAMH to:

  • Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment
  • Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.

Objectives

• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Center for Addiction and Mental Health (CAMH)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Patients receiving rTMS

  • Smoking cigarettes daily (self-reported)

Inclusion Criteria: Health care providers

  • Currently employed as a HCP (physician, social worker, occupational therapist, etc.) at the CAMH NDC
  • Involved in the care of at least 1 patient who has received rTMS for smoking cessation

Exclusion Criteria: Patients receiving rTMS

  • 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.
  • Taking any anticonvulsant medication unless it cannot be tapered or discontinued due to risk of clinical safety or destabilization, according to the participant or their referring physician.
  • Taking benzodiazepines with dose equivalent or greater than lorazepam 2mg/day unless it cannot be tapered or discontinued due to risk of clinical safety or destabilization, according to the participant or their referring physician.
  • Space occupying intracranial lesion.
  • Acutely unstable medical, psychiatric, or substance use disorder comorbidity with safety concerns at the discretion of the PI or study physician.

Exclusion Criteria: Health care providers

- There are no exclusion criteria for HCP Participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients Receiving rTMS
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.
Device: Brainsway H4 deep rTMS coil and Brainsway stimulator system

An rTMS treatment course consisting of daily treatment, 5 days per week, for 3 weeks, followed by once weekly treatments for 3 weeks, for a total of 18 treatment sessions over 6 weeks.

Sixty trains of 30 pulses each (total 1,800 pulses) will be applied at 10 Hz, for 3 second trains, with a 15 second inter-train interval, for approximately 18 minutes of treatment time.

At each rTMS treatment session, prior to stimulation, participants will undergo a smoking craving provocation procedure where they will be asked to close their eyes and imagine one of their triggers for 30 seconds. Following this they will watch a PowerPoint presentation of smoking pictures for 2 minutes and 30 seconds. Thus, the entire craving provocation procedure will be 3 minutes prior to stimulation start.

Brief behavioural support will be available to the participant on a weekly basis by a trained research staff member from the NDC.

Other Names:
  • Deep rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, an average of 1 year
The proportion of patients accepting rTMS relative to all patients with a visit to the NDC during the study period.
Through study completion, an average of 1 year
Identify rates of adoption of rTMS in Nicotine Dependence Clinic
Time Frame: Through study completion, an average of 1 year
What percentage of NDC HCPs refer patients to rTMS treatment? (Adoption)
Through study completion, an average of 1 year
Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach.
Time Frame: Through study completion, an average of 1 year

Research questions assessed through through surveys and semi-structured interviews

  1. What are the multi-level barriers and facilitators to integrating rTMS in NDC?
  2. How acceptable, appropriate and feasible is it to integrate rTMS in NDC?
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC.
Time Frame: Through study completion, an average of 1 year
Self-reported 4-week continuous quit rate and long follow-up continuous quit rate (biochemically verified by urine nicotine/tobacco metabolite collection and analysis at end of treatment and the long follow-up).
Through study completion, an average of 1 year
Explore patient-HCP communication about shared treatment decision-making for rTMS.
Time Frame: Through study completion, an average of 1 year
We will conduct semi-structured interviews with NDC patients and HCPs to better understand the collaborative nature and necessary communication components involved in shared treatment decision-making for rTMS.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Victor Tang, MD, MSc, Center for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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