Implementation of Transcranial Magnetic Stimulation for Smoking Cessation

NCT06346028 | Recruiting Phase 4

• 1 other identifier: 2023/086
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking

Keywords

smoking cessation; quitting smoking; repetitive transcranial magnetic stimulation; rTMS; nicotine dependence

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  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 Outcomes (2)

• Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC.

  Through study completion, an average of 1 year

• Explore patient-HCP communication about shared treatment decision-making for rTMS.

  Through study completion, an average of 1 year

Study Arms (1)

Patients Receiving rTMS

EXPERIMENTAL

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

Interventions

Brainsway H4 deep rTMS coil and Brainsway stimulator system DEVICE

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.

Also known as: Deep rTMS

Patients Receiving rTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking cigarettes daily (self-reported)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Victor Tang, MD, MSc

  Center for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra S, BScH

CONTACT

416-535-8501; rtms.smoking@camh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 3, 2024
• Study Start: March 30, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CA (1)