Tobacco Use DisorderPhase 4NCT06534047
Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial
A Phase 4 study testing Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil and Nicotine replacement in people with Tobacco Use Disorder and Psychiatric Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Use Disorder, Psychiatric Disorder, Nicotine Dependence
- What is being tested?
- Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil and Nicotine replacement
- 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
- 1 Sep 2024to 1 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Participants:
- The patient participant must meet all the inclusion criteria to be eligible for this study:
- Able to provide informed consent.
- Age 18-70.
- Self-reported daily tobacco cigarette consumption.
- Meet DSM-5 criteria for a psychiatric disorder that includes one of the following: mood disorders (e.g. major depressive disorder, bipolar disorder), anxiety disorders (e.g. panic disorder, social anxiety disorder), psychotic disorders (e.g. schizophrenia), posttraumatic stress disorder, obsessive compulsive disorders, or other substance use disorders (e.g. alcohol use disorder) as determined by the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5 RV).
- Interested in using either Repetitive Transcranial Magnetic Stimulation (rTMS) or nicotine replacement therapy as a smoking cessation treatment.
- Intending on quitting smoking within the next 30 days.
Who cannot join
- Patient Participants:
- Contraindication to rTMS according to the TMS Adult Safety Screen (TASS) and PI review.
- 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.
- Space occupying intracranial lesion.
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- Any generalized skin disorders precluding the use of the nicotine patch.
- Any known hypersensitivity or allergies to the nicotine patch.
- Any known life-threatening arrhythmias or severe/worsening angina pectoris.
- Within two weeks of experiencing a myocardial infarction or cerebral vascular accident.
- Currently using or has used nicotine replacement therapy within the past two weeks.
- Diagnosed with a terminal illness
- Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop using these devices for the duration of the study.
- Acutely unstable medical, psychiatric, or substance use disorder comorbidity with safety concerns at the discretion of the PI or study physician.
- Previous treatment with rTMS for smoking cessation
- Treatment with nicotine replacement therapy anytime within the last 1 month
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
Centre for Addiction and Mental Health
Toronto, Ontario
Victor M Tang, MD, rtms.smoking@camh.ca
About this study
Official title: Integrating Transcranial Magnetic Stimulation as a Treatment for Nicotine Dependence in the Clinic: A Pragmatic, Hybrid Effectiveness-Implementation Trial
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Additionally, tobacco use is substantially higher in individuals with comorbid mental illness, constituting a particularly vulnerable population. As such, the development of multiple evidence-based treatments for smoking cessation is of upmost importance.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of substance use disorders. Recently, a deep TMS coil has been cleared by the Food and Drug Administration (FDA) as efficacious for tobacco use disorder, representing the first rTMS indication for addictions. Before adoption of this intervention into smoking cessation clinics, it is important to investigate whether implementation of rTMS into clinical care is feasible, acceptable, and appropriate for patients receiving care for nicotine dependence.
The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation. Also, barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS.
Read the detailed description
The objective is to pilot a pragmatic, randomized, comparative effectiveness trial of rTMS, compared to treatment as usual (TAU), for smoking cessation in individuals with psychiatric comorbidities, using a type 1 hybrid effectiveness-implementation design. Participants will be included if they meet DSM-5 criteria for mood disorders, anxiety disorders, psychotic disorders, posttraumatic stress disorder, obsessive compulsive disorders, or other substance use disorders. Those that undergo rTMS treatment will be offered open-label rTMS treatment with the FDA and Health Canada approved Brainsway deep TMS (dTMS) coil which includes 3 weeks of daily on-site rTMS treatments followed by 3 weeks of weekly treatments. Those that undergo TAU will receive nicotine replacement therapy and counselling through the supervision of a study physician.
- Being tested
- Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil, Nicotine replacement
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Nicotine Dependence, Smoking Cessation
- Medical subject headings
- Tobacco Use Disorder, Mental Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coilDevice
Also called Deep TMS
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 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.
Nicotine replacementDrug
Also called Treatment As Usual
Each participant will receive individualized NRT treatment through the advice of their study physician for 6 weeks. The study physician, in discussion with the participant, will decide the type, dosage, and combination of NRT to provide to the participant.
NRT provided can include:
- Patch (7mg, 14mg, and 21mg)
- Gum (2mg)
- Lozenge (2mg)
- Inhaler (10mg; 4mg of nicotine delivered)
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention | Experimental | 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. Receives: Device: Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil |
| Treatment as Usual | Active comparator | Treatment with Nicotine Replacement Therapy (NRT) and/or adjunctive counselling will be provided by their clinical team through the Smoking Treatment for Ontario Patients (STOP) Program. All treatments will be delivered by study physicians in the Nicotine Dependence Clinic at CAMH, all of whom administer NRT through the STOP program. Receives: Drug: Nicotine replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of conducting a pragmatic, hybrid effectiveness implementation trial of Repetitive Transcranial Magnetic Stimulation (rTMS) versus treatment as usual (TAU).
Recruitment over the 2-year study period will be measured, with a target sample of 40. Retention will be determined by the proportion of people who complete 50% of the treatments.
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Estimate the difference in effectiveness between Repetitive Transcranial Magnetic Stimulation (rTMS) and Treatment As Usual (TAU) on smoking cessation rates in real world patients with psychiatric comorbidities.
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: After completion of the intervention (rTMS or TAU; up to 6 weeks)
Estimate the implementation of Repetitive Transcranial Magnetic Stimulation (rTMS) in routine clinical care.
Semi-structured interviews with NDC patients and healthcare providers 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 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type 1 Implementation effectiveness trial. Open label, randomized, parallel 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 M Tang, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534047
- Sponsor's protocol ID
- 2024-018
- Status last verified
- Dec 2024
- First submitted
- 7 Jun 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Transcranial Magnetic Stimulation as a Treatment for Nicotine Dependence in the Clinic: A Pragmatic, Hybrid Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT06534047
- Acronym / sponsor ID
- 2024-018
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Nicotine Dependence, Smoking Cessation
- 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
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Aug 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.
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Additionally, tobacco use is substantially higher in individuals with comorbid mental illness, constituting a particularly vulnerable population. As such, the development of multiple evidence-based treatments for smoking cessation is of upmost importance.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of substance use disorders. Recently, a deep TMS coil has been cleared by the Food and Drug Administration (FDA) as efficacious for tobacco use disorder, representing the first rTMS indication for addictions. Before adoption of this intervention into smoking cessation clinics, it is important to investigate whether implementation of rTMS into clinical care is feasible, acceptable, and appropriate for patients receiving care for nicotine dependence.
The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation. Also, barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS.
Detailed description
The objective is to pilot a pragmatic, randomized, comparative effectiveness trial of rTMS, compared to treatment as usual (TAU), for smoking cessation in individuals with psychiatric comorbidities, using a type 1 hybrid effectiveness-implementation design. Participants will be included if they meet DSM-5 criteria for mood disorders, anxiety disorders, psychotic disorders, posttraumatic stress disorder, obsessive compulsive disorders, or other substance use disorders. Those that undergo rTMS treatment will be offered open-label rTMS treatment with the FDA and Health Canada approved Brainsway deep TMS (dTMS) coil which includes 3 weeks of daily on-site rTMS treatments followed by 3 weeks of weekly treatments. Those that undergo TAU will receive nicotine replacement therapy and counselling through the supervision of a study physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type 1 Implementation effectiveness trial. Open label, randomized, parallel group
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention | Experimental | Device: Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coilTreatment 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. |
| Treatment as Usual | Active comparator | Drug: Nicotine replacementTreatment with Nicotine Replacement Therapy (NRT) and/or adjunctive counselling will be provided by their clinical team through the Smoking Treatment for Ontario Patients (STOP) Program. All treatments will be delivered by study physicians in the Nicotine Dependence Clinic at CAMH, all of whom administer NRT through the STOP program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient participant must meet all the inclusion criteria to be eligible for this study:
- Able to provide informed consent.
- Age 18-70.
- Self-reported daily tobacco cigarette consumption.
- Meet DSM-5 criteria for a psychiatric disorder that includes one of the following: mood disorders (e.g. major depressive disorder, bipolar disorder), anxiety disorders (e.g. panic disorder, social anxiety disorder), psychotic disorders (e.g. schizophrenia), posttraumatic stress disorder, obsessive compulsive disorders, or other substance use disorders (e.g. alcohol use disorder) as determined by the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5 RV).
Key exclusion criteria (16 listed)
- Contraindication to rTMS according to the TMS Adult Safety Screen (TASS) and PI review.
- 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.
- Space occupying intracranial lesion.
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 Repetitive Transcranial Magnetic Stimulation (rTMS) coilAlso: Deep TMSAn 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 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. | Device | Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention |
| Nicotine replacementAlso: Treatment As UsualEach participant will receive individualized NRT treatment through the advice of their study physician for 6 weeks. The study physician, in discussion with the participant, will decide the type, dosage, and combination of NRT to provide to the participant. NRT provided can include: * Patch (7mg, 14mg, and 21mg) * Gum (2mg) * Lozenge (2mg) * Inhaler (10mg; 4mg of nicotine delivered) | Drug | Treatment as Usual |
Primary outcome
Evaluate the feasibility of conducting a pragmatic, hybrid effectiveness implementation trial of Repetitive Transcranial Magnetic Stimulation (rTMS) versus treatment as usual (TAU).
Time frame: Through study completion, an average of 2 years
Recruitment over the 2-year study period will be measured, with a target sample of 40. Retention will be determined by the proportion of people who complete 50% of the treatments.
2 secondary outcomes
Estimate the difference in effectiveness between Repetitive Transcranial Magnetic Stimulation (rTMS) and Treatment As Usual (TAU) on smoking cessation rates in real world patients with psychiatric comorbidities.
Time frame: After completion of the intervention (rTMS or TAU; up to 6 weeks)
Estimate the implementation of Repetitive Transcranial Magnetic Stimulation (rTMS) in routine clinical care.
Time frame: Through study completion, an average of 2 years
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 11 Dec 2025.
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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 M Tang, MD principal investigator
Centre 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 Repetitive Transcranial Magnetic Stimulation (rTMS) coil and Nicotine replacement in people with Tobacco Use Disorder and Psychiatric Disorder, 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 8 inclusion and 16 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 11 Dec 2025. 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 Victor M Tang, MD (416-535-8501, victor.tang@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of conducting a pragmatic, hybrid effectiveness implementation trial of Repetitive Transcranial Magnetic Stimulation (rTMS) versus treatment as usual (TAU). (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.