Recruiting

rTMS

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06346028

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Brainsway H4 deep rTMS coil and Brainsway stimulator system

Study Details

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

Study ID

NCT06346028

Start date

Mar 30, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 ]
  • Identify rates of adoption of rTMS in Nicotine Dependence Clinic [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Alexandra S, BScH

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

Locations

Center for Addiction and Mental Health (CAMH)

Recruiting

Toronto, Ontario, Canada

Contacts

Alexandra S, BScH

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

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-03-27.