Clinical trial NCT06346028: Implementation of Transcranial Magnetic Stimulation for Smoking Cessation
Official title: A Pragmatic Feasibility Trial on the Implementation of Transcranial Magnetic Stimulation for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Smoking
Keywords: smoking cessation
quitting smoking
repetitive transcranial magnetic stimulation
rTMS
nicotine dependence
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: Through study completion, an average of 1 year
measure: Identify rates of adoption of rTMS in Nicotine Dependence Clinic
timeFrame: Through study completion, an average of 1 year
measure: Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC.
timeFrame: Through study completion, an average of 1 year
measure: Explore patient-HCP communication about shared treatment decision-making for rTMS.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health (CAMH)
state: Ontario
Study officials:
affiliation: Center for Addiction and Mental Health
name: Victor Tang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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