Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346028
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-20
Brief Title:
Implementation of Transcranial Magnetic Stimulation for Smoking Cessation
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
A Pragmatic Feasibility Trial on the Implementation of Transcranial Magnetic Stimulation for Smoking Cessation
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 peoples overall health
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 peoples overall health
Detailed Description:
Approximately 45000 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 studys 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 peoples overall health
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 studys 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 peoples overall health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None