SmokingPhase 4NCT06346028
Implementation of Transcranial Magnetic Stimulation for Smoking Cessation
A Phase 4 study testing Brainsway H4 deep rTMS coil and Brainsway stimulator system in people with Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Brainsway H4 deep rTMS coil and Brainsway stimulator system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2024to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- There are no exclusion criteria for HCP Participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario
Alexandra S, BScH, 416-535-8501 ext. 31551, rtms.smoking@camh.ca
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Brainsway H4 deep rTMS coil and Brainsway stimulator system
- Keywords
- smoking cessation, quitting smoking, repetitive transcranial magnetic stimulation, rTMS, nicotine dependence
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainsway H4 deep rTMS coil and Brainsway stimulator systemDevice
Also called Deep rTMS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Brainsway H4 deep rTMS coil and Brainsway stimulator system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
- What are the multi-level barriers and facilitators to integrating rTMS in NDC?
- How acceptable, appropriate and feasible is it to integrate rTMS in NDC?
Measured: 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.
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).
Measured: Through study completion, an average of 1 year
Explore patient-HCP communication about shared treatment decision-making for rTMS.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Tang, MD, MSc, Principal investigator, Center for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346028
- Sponsor's protocol ID
- 2023/086
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zangen A, Moshe H, Martinez D, Barnea-Ygael N, Vapnik T, Bystritsky A, Duffy W, Toder D, Casuto L, Grosz ML, Nunes EV, Ward H, Tendler A, Feifel D, Morales O, Roth Y, Iosifescu DV, Winston J, Wirecki T, Stein A, Deutsch F, Li X, George MS. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry. 2021 Oct;20(3):397-404. doi: 10.1002/wps.20905.
PubMed 34505368Ekhtiari H, Tavakoli H, Addolorato G, Baeken C, Bonci A, Campanella S, Castelo-Branco L, Challet-Bouju G, Clark VP, Claus E, Dannon PN, Del Felice A, den Uyl T, Diana M, di Giannantonio M, Fedota JR, Fitzgerald P, Gallimberti L, Grall-Bronnec M, Herremans SC, Herrmann MJ, Jamil A, Khedr E, Kouimtsidis C, Kozak K, Krupitsky E, Lamm C, Lechner WV, Madeo G, Malmir N, Martinotti G, McDonald WM, Montemitro C, Nakamura-Palacios EM, Nasehi M, Noel X, Nosratabadi M, Paulus M, Pettorruso M, Pradhan B, Praharaj SK, Rafferty H, Sahlem G, Salmeron BJ, Sauvaget A, Schluter RS, Sergiou C, Shahbabaie A, Sheffer C, Spagnolo PA, Steele VR, Yuan TF, van Dongen JDM, Van Waes V, Venkatasubramanian G, Verdejo-Garcia A, Verveer I, Welsh JW, Wesley MJ, Witkiewitz K, Yavari F, Zarrindast MR, Zawertailo L, Zhang X, Cha YH, George TP, Frohlich F, Goudriaan AE, Fecteau S, Daughters SB, Stein EA, Fregni F, Nitsche MA, Zangen A, Bikson M, Hanlon CA. Transcranial electrical and magnetic stimulation (tES and TMS) for addiction medicine: A consensus paper on the present state of the science and the road ahead. Neurosci Biobehav Rev. 2019 Sep;104:118-140. doi: 10.1016/j.neubiorev.2019.06.007. Epub 2019 Jul 2.
PubMed 31271802Miron JP, Jodoin VD, Lesperance P, Blumberger DM. Repetitive transcranial magnetic stimulation for major depressive disorder: basic principles and future directions. Ther Adv Psychopharmacol. 2021 Sep 23;11:20451253211042696. doi: 10.1177/20451253211042696. eCollection 2021.
PubMed 34589203Zhang JJQ, Fong KNK, Ouyang RG, Siu AMH, Kranz GS. Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. Addiction. 2019 Dec;114(12):2137-2149. doi: 10.1111/add.14753. Epub 2019 Aug 16.
PubMed 31328353Seewoo BJ, Hennessy LA, Jaeschke LA, Mackie LA, Etherington SJ, Dunlop SA, Croarkin PE, Rodger J. A Preclinical Study of Standard Versus Accelerated Transcranial Magnetic Stimulation for Depression in Adolescents. J Child Adolesc Psychopharmacol. 2022 Apr;32(3):187-193. doi: 10.1089/cap.2021.0100. Epub 2021 Dec 31.
PubMed 34978846Pushparaj A, Hamani C, Yu W, Shin DS, Kang B, Nobrega JN, Le Foll B. Electrical stimulation of the insular region attenuates nicotine-taking and nicotine-seeking behaviors. Neuropsychopharmacology. 2013 Mar;38(4):690-8. doi: 10.1038/npp.2012.235. Epub 2012 Nov 15.
PubMed 23249816Moretti J, Poh EZ, Rodger J. rTMS-Induced Changes in Glutamatergic and Dopaminergic Systems: Relevance to Cocaine and Methamphetamine Use Disorders. Front Neurosci. 2020 Mar 6;14:137. doi: 10.3389/fnins.2020.00137. eCollection 2020.
PubMed 32210744Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449Malik S, Jacobs M, Cho SS, Boileau I, Blumberger D, Heilig M, Wilson A, Daskalakis ZJ, Strafella AP, Zangen A, Le Foll B. Deep TMS of the insula using the H-coil modulates dopamine release: a crossover [11C] PHNO-PET pilot trial in healthy humans. Brain Imaging Behav. 2018 Oct;12(5):1306-1317. doi: 10.1007/s11682-017-9800-1.
PubMed 29170944McGirr A, Karmani S, Arsappa R, Berlim MT, Thirthalli J, Muralidharan K, Yatham LN. Clinical efficacy and safety of repetitive transcranial magnetic stimulation in acute bipolar depression. World Psychiatry. 2016 Feb;15(1):85-6. doi: 10.1002/wps.20300. No abstract available.
PubMed 26833619Dobek CE, Blumberger DM, Downar J, Daskalakis ZJ, Vila-Rodriguez F. Risk of seizures in transcranial magnetic stimulation: a clinical review to inform consent process focused on bupropion. Neuropsychiatr Dis Treat. 2015 Nov 30;11:2975-87. doi: 10.2147/NDT.S91126. eCollection 2015.
PubMed 26664122Keel JC, Smith MJ, Wassermann EM. A safety screening questionnaire for transcranial magnetic stimulation. Clin Neurophysiol. 2001 Apr;112(4):720. doi: 10.1016/s1388-2457(00)00518-6. No abstract available.
PubMed 11332408Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
PubMed 10474547McClintock SM, Reti IM, Carpenter LL, McDonald WM, Dubin M, Taylor SF, Cook IA, O'Reardon J, Husain MM, Wall C, Krystal AD, Sampson SM, Morales O, Nelson BG, Latoussakis V, George MS, Lisanby SH; National Network of Depression Centers rTMS Task Group; American Psychiatric Association Council on Research Task Force on Novel Biomarkers and Treatments. Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. J Clin Psychiatry. 2018 Jan/Feb;79(1):16cs10905. doi: 10.4088/JCP.16cs10905.
PubMed 28541649
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Feasibility Trial on the Implementation of Transcranial Magnetic Stimulation for Smoking Cessation
- ClinicalTrials.gov ID
- NCT06346028
- Acronym / sponsor ID
- 2023/086
- Conditions
- Smoking
- Keywords
- smoking cessation, quitting smoking, repetitive transcranial magnetic stimulation, rTMS, nicotine dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving rTMS | Experimental | Device: Brainsway H4 deep rTMS coil and Brainsway stimulator systemParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brainsway H4 deep rTMS coil and Brainsway stimulator systemAlso: Deep rTMSAn 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. | Device | Patients Receiving rTMS |
Primary outcome
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.
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)
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?
2 secondary outcomes
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
Explore patient-HCP communication about shared treatment decision-making for rTMS.
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 34505368Zangen A, Moshe H, Martinez D, Barnea-Ygael N, Vapnik T, Bystritsky A, Duffy W, Toder D, Casuto L, Grosz ML, Nunes EV, Ward H, Tendler A, Feifel D, Morales O, Roth Y, Iosifescu DV, Winston J, Wirecki T, Stein A, Deutsch F, Li X, George MS. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry. 2021 Oct;20(3):397-404. doi: 10.1002/wps.20905.
- Background: PubMed 31271802Ekhtiari H, Tavakoli H, Addolorato G, Baeken C, Bonci A, Campanella S, Castelo-Branco L, Challet-Bouju G, Clark VP, Claus E, Dannon PN, Del Felice A, den Uyl T, Diana M, di Giannantonio M, Fedota JR, Fitzgerald P, Gallimberti L, Grall-Bronnec M, Herremans SC, Herrmann MJ, Jamil A, Khedr E, Kouimtsidis C, Kozak K, Krupitsky E, Lamm C, Lechner WV, Madeo G, Malmir N, Martinotti G, McDonald WM, Montemitro C, Nakamura-Palacios EM, Nasehi M, Noel X, Nosratabadi M, Paulus M, Pettorruso M, Pradhan B, Praharaj SK, Rafferty H, Sahlem G, Salmeron BJ, Sauvaget A, Schluter RS, Sergiou C, Shahbabaie A, Sheffer C, Spagnolo PA, Steele VR, Yuan TF, van Dongen JDM, Van Waes V, Venkatasubramanian G, Verdejo-Garcia A, Verveer I, Welsh JW, Wesley MJ, Witkiewitz K, Yavari F, Zarrindast MR, Zawertailo L, Zhang X, Cha YH, George TP, Frohlich F, Goudriaan AE, Fecteau S, Daughters SB, Stein EA, Fregni F, Nitsche MA, Zangen A, Bikson M, Hanlon CA. Transcranial electrical and magnetic stimulation (tES and TMS) for addiction medicine: A consensus paper on the present state of the science and the road ahead. Neurosci Biobehav Rev. 2019 Sep;104:118-140. doi: 10.1016/j.neubiorev.2019.06.007. Epub 2019 Jul 2.
- Background: PubMed 34589203Miron JP, Jodoin VD, Lesperance P, Blumberger DM. Repetitive transcranial magnetic stimulation for major depressive disorder: basic principles and future directions. Ther Adv Psychopharmacol. 2021 Sep 23;11:20451253211042696. doi: 10.1177/20451253211042696. eCollection 2021.
- Background: PubMed 31328353Zhang JJQ, Fong KNK, Ouyang RG, Siu AMH, Kranz GS. Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. Addiction. 2019 Dec;114(12):2137-2149. doi: 10.1111/add.14753. Epub 2019 Aug 16.
- Background: PubMed 34978846Seewoo BJ, Hennessy LA, Jaeschke LA, Mackie LA, Etherington SJ, Dunlop SA, Croarkin PE, Rodger J. A Preclinical Study of Standard Versus Accelerated Transcranial Magnetic Stimulation for Depression in Adolescents. J Child Adolesc Psychopharmacol. 2022 Apr;32(3):187-193. doi: 10.1089/cap.2021.0100. Epub 2021 Dec 31.
- Background: PubMed 23249816Pushparaj A, Hamani C, Yu W, Shin DS, Kang B, Nobrega JN, Le Foll B. Electrical stimulation of the insular region attenuates nicotine-taking and nicotine-seeking behaviors. Neuropsychopharmacology. 2013 Mar;38(4):690-8. doi: 10.1038/npp.2012.235. Epub 2012 Nov 15.
- Background: PubMed 32210744Moretti J, Poh EZ, Rodger J. rTMS-Induced Changes in Glutamatergic and Dopaminergic Systems: Relevance to Cocaine and Methamphetamine Use Disorders. Front Neurosci. 2020 Mar 6;14:137. doi: 10.3389/fnins.2020.00137. eCollection 2020.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Background: PubMed 29170944Malik S, Jacobs M, Cho SS, Boileau I, Blumberger D, Heilig M, Wilson A, Daskalakis ZJ, Strafella AP, Zangen A, Le Foll B. Deep TMS of the insula using the H-coil modulates dopamine release: a crossover [11C] PHNO-PET pilot trial in healthy humans. Brain Imaging Behav. 2018 Oct;12(5):1306-1317. doi: 10.1007/s11682-017-9800-1.
- Background: PubMed 26833619McGirr A, Karmani S, Arsappa R, Berlim MT, Thirthalli J, Muralidharan K, Yatham LN. Clinical efficacy and safety of repetitive transcranial magnetic stimulation in acute bipolar depression. World Psychiatry. 2016 Feb;15(1):85-6. doi: 10.1002/wps.20300. No abstract available.
- Background: PubMed 26664122Dobek CE, Blumberger DM, Downar J, Daskalakis ZJ, Vila-Rodriguez F. Risk of seizures in transcranial magnetic stimulation: a clinical review to inform consent process focused on bupropion. Neuropsychiatr Dis Treat. 2015 Nov 30;11:2975-87. doi: 10.2147/NDT.S91126. eCollection 2015.
- Background: PubMed 11332408Keel JC, Smith MJ, Wassermann EM. A safety screening questionnaire for transcranial magnetic stimulation. Clin Neurophysiol. 2001 Apr;112(4):720. doi: 10.1016/s1388-2457(00)00518-6. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Tang, MD, MSc principal investigator
Center for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brainsway H4 deep rTMS coil and Brainsway stimulator system in people with Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra S, BScH (416-535-8501 ext. 31551, rtms.smoking@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06346028, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.