Tobacco Use DisorderPhase 2NCT07292883
Accelerated dTMS Smoking Cessation
A Phase 2 study testing Bilateral deep accelerated repetitive transcranial magnetic stimulation in people with Tobacco Use Disorder and Addiction Nicotine, run by Waypoint Centre for Mental Health Care at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) is a feasible treatment to help adults (18-65) with Tobacco Use Disorder to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Addiction Nicotine
- What is being tested?
- Bilateral deep accelerated repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Feb 2026to 1 Jan 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older;
- Tobacco use disorder as assessed by DSM-5;
- Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
- Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures.
- Able to communicate in English.
Who cannot join
- Reported smoking abstinence in the 3 months preceding screening visit;
- Current use of other smoking cessation aids;
- Contraindication to rTMS;
- Pregnancy, trying to become pregnant or breastfeeding;
- Current or recent history of cerebrovascular disease;
- Unstable major psychiatric disorder(s) (i.e. Axis I Disorders) that would prevent participation in the study at PI (or its delegate) discretion;
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- Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.) preventing same inclusion as per PI (or its delegate) discretion;
- Current, personal history or family history of seizures;
- Concomitant use of medication that lowers seizure threshold, such as clozapine;
- Concomitant use of more than 2 mg lorazepam (or an equivalent) or any anticonvulsants.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Waypoint Centre for Mental Health Care
Penetanguishene, Ontario
Florence Tang, Masters of Arts, 705-549-3181 ext. 3040, ftang@waypointcentre.ca
Vincent Wang, MD, 647-522-3415 ext. 3040, xi-yu.wang@camh.ca
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Florence Tang, Masters of Arts, 705-549-3181 ext. 3040, ftang@waypointcentre.ca
Vincent Wang, MD, 647-522-3415, xi-yu.wang@camh.ca
About this study
Official title: Accelerated Deep Transcranial Magnetic Stimulation for Smoking Cessation
The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) is a feasible treatment to help adults (18-65) with Tobacco Use Disorder to quit smoking. This study aims to enroll 30-40 participants and will examine treatment tolerability, treatment acceptability, participant retention, and adherence to scheduled treatment sessions.
There are two key objectives and hypotheses:
Read more
Objective 1: To evaluate whether a 1-week course of bilateral aTMS (4 sessions per day for 5 days) is feasible and tolerable as a smoking cessation treatment.
Hypothesis 1: Feasibility will be demonstrated by acceptable tolerability, acceptability, retention, and adherence, with a practical target of 30 out of 40 participants completing the treatment.
Objective 2: To explore how aTMS affects smoking outcomes, including:
- Point-prevalence abstinence at end of treatment and at Weeks 3, 5, and 9.
- Prolonged/continuous abstinence at Weeks 13 and 26.
- Craving, cigarettes per day, and dependence severity. Hypothesis 2: Participants will show improvements on these outcomes from post-treatment through follow-up.
- Conditions
- Tobacco Use Disorder, Addiction Nicotine
- Being tested
- Bilateral deep accelerated repetitive transcranial magnetic stimulation
- Keywords
- addiction, smoking cessation, Transcranial Magnetic Stimulation, Accelerated Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Tobacco Use Disorder, Behavior, Addictive, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral deep accelerated repetitive transcranial magnetic stimulationDevice
Also called Deep TMS, Accelerated TMS, Repetitive TMS
Accelerated Repetitive Transcranial Magnetic Stimulation (aTMS) is a type of treatment that will be used to target the bilateral insular cortex and prefrontal cortex using the Health Canada-approved H4 coil. The purpose is to test its feasibility on smoking abstinence. While convention rTMS methods involves one session daily over several weeks, aTMS delivers multiple sessions per day. Using the H4 deep aTMS, this study will implement 20 sessions over five consecutive days (four sessions daily).
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Repetitive Transcranial Magnetic Stimulation | Experimental | Bilateral Accelerated Repetitive Transcranial Magnetic Stimulation targeting the insula and prefrontal cortex using H4 coil Receives: Device: Bilateral deep accelerated repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects
Tolerability will be assessed by calculating the percentage of participants who discontinue the 5-day accelerated dTMS treatment course due to side effects.
Measured: From week 1 day 1, to week 1 day 5 of treatment week.
TMS Experience Questionnaire Acceptability Scores (Units on a Scale)
Acceptability will be assessed using scores on the TMS Experience Questionnaire.
Measured: From week 1 day 1, to week 1 day 5 of treatment week.
Percentage of Participants Completing the 5-day Accelerated dTMS Treatment Course
Retention will be measured by the percentage of enrolled participants who complete the full 5-day accelerated dTMS treatment protocol (4 sessions per day for 5 days). The aim is 30 out of 40 participants (75%) completing the course.
Measured: From week 1 day 1, to week 5 day 5 of treatment week.
Percentage of Treatment Sessions Attended
Adherence will be measured by calculating the percentages of planned accelerated dTMS treatment sessions attended (20 sessions total over 5 days). For each participant, adherence will be calculated as number of sessions attended divided by 20, and then calculating a mean percentage.
Measured: From week 1 day 1, to week 1 day 5 of treatment week.
Secondary outcomes (5)
The percentage of participants achieving continuous short-term abstinence at follow up
Measuring the percentage of participants who achieved 7-day point prevalence abstinence at the end of treatment, week 3, week 5, week 9, week, 13, week 26.
Measured: From week 1 day 5 of treatment to week 26.
The percentage of participants achieving continuous long-term abstinence at follow up
Calculating the percentage of participants who achieved prolonged and continuous absence at week 13 (3 months) and week 26 (6 months).
Measured: From week 1 day 1 of treatment to week 26.
Change in Tobacco Craving Questionnaire-Short Form (TCQ-SF) Total Score (Units on a Scale)
This outcome will examine changes in self-reported cravings using the TCQ-SF. TCQ-SF total scores will be compared from baseline to the end of treatment (week 26) and across follow-up visits (week 3, 5, 9, 13, 26).
Measured: From baseline to week 26.
Change in Dependence Severity (Units on a Scale)
This outcome will examine changes in nicotine dependence severity from baseline to the end of treatment (week 26) and during follow-up visits (week 3, 5, 9, 13) using the Fagerstrom Test for Nicotine Dependence (FTND).
Measured: From baseline to week 26.
Change in Daily Cigarette Use (Number of Cigarettes per Day)
This outcome will examine changes in self-reported cigarette consumption using the Timeline Follow Back method from baseline through follow-ups (week 3, 5, 9, 13) to the end of the study (week 26).
Measured: From baseline to week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start24 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completion1 Jan 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waypoint Centre for Mental Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS, Principal investigator, Waypoint Centre for Mental Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292883
- Sponsor's protocol ID
- 5240
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans for use of your study data in other research.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Deep Transcranial Magnetic Stimulation for Smoking Cessation
- ClinicalTrials.gov ID
- NCT07292883
- Acronym / sponsor ID
- 5240
- Conditions
- Tobacco Use Disorder, Addiction Nicotine
- Keywords
- addiction, smoking cessation, Transcranial Magnetic Stimulation, Accelerated Repetitive Transcranial Magnetic Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Waypoint Centre for Mental Health CareUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 18 Dec 2025 (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.
The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) is a feasible treatment to help adults (18-65) with Tobacco Use Disorder to quit smoking. This study aims to enroll 30-40 participants and will examine treatment tolerability, treatment acceptability, participant retention, and adherence to scheduled treatment sessions.
There are two key objectives and hypotheses:
Objective 1: To evaluate whether a 1-week course of bilateral aTMS (4 sessions per day for 5 days) is feasible and tolerable as a smoking cessation treatment.
Hypothesis 1: Feasibility will be demonstrated by acceptable tolerability, acceptability, retention, and adherence, with a practical target of 30 out of 40 participants completing the treatment.
Objective 2: To explore how aTMS affects smoking outcomes, including:
- Point-prevalence abstinence at end of treatment and at Weeks 3, 5, and 9.
- Prolonged/continuous abstinence at Weeks 13 and 26.
- Craving, cigarettes per day, and dependence severity. Hypothesis 2: Participants will show improvements on these outcomes from post-treatment through follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated Repetitive Transcranial Magnetic Stimulation | Experimental | Device: Bilateral deep accelerated repetitive transcranial magnetic stimulationBilateral Accelerated Repetitive Transcranial Magnetic Stimulation targeting the insula and prefrontal cortex using H4 coil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older;
- Tobacco use disorder as assessed by DSM-5;
- Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
- Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7;
- Must sign and date the informed consent form;
Key exclusion criteria (10 listed)
- Reported smoking abstinence in the 3 months preceding screening visit;
- Current use of other smoking cessation aids;
- Contraindication to rTMS;
- Pregnancy, trying to become pregnant or breastfeeding;
- Current or recent history of cerebrovascular disease;
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 |
|---|---|---|
| Bilateral deep accelerated repetitive transcranial magnetic stimulationAlso: Deep TMS, Accelerated TMS, Repetitive TMSAccelerated Repetitive Transcranial Magnetic Stimulation (aTMS) is a type of treatment that will be used to target the bilateral insular cortex and prefrontal cortex using the Health Canada-approved H4 coil. The purpose is to test its feasibility on smoking abstinence. While convention rTMS methods involves one session daily over several weeks, aTMS delivers multiple sessions per day. Using the H4 deep aTMS, this study will implement 20 sessions over five consecutive days (four sessions daily). | Device | Accelerated Repetitive Transcranial Magnetic Stimulation |
Primary outcome
Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects
Time frame: From week 1 day 1, to week 1 day 5 of treatment week.
Tolerability will be assessed by calculating the percentage of participants who discontinue the 5-day accelerated dTMS treatment course due to side effects.
TMS Experience Questionnaire Acceptability Scores (Units on a Scale)
Time frame: From week 1 day 1, to week 1 day 5 of treatment week.
Acceptability will be assessed using scores on the TMS Experience Questionnaire.
Percentage of Participants Completing the 5-day Accelerated dTMS Treatment Course
Time frame: From week 1 day 1, to week 5 day 5 of treatment week.
Retention will be measured by the percentage of enrolled participants who complete the full 5-day accelerated dTMS treatment protocol (4 sessions per day for 5 days). The aim is 30 out of 40 participants (75%) completing the course.
Percentage of Treatment Sessions Attended
Time frame: From week 1 day 1, to week 1 day 5 of treatment week.
Adherence will be measured by calculating the percentages of planned accelerated dTMS treatment sessions attended (20 sessions total over 5 days). For each participant, adherence will be calculated as number of sessions attended divided by 20, and then calculating a mean percentage.
5 secondary outcomes
The percentage of participants achieving continuous short-term abstinence at follow up
Time frame: From week 1 day 5 of treatment to week 26.
The percentage of participants achieving continuous long-term abstinence at follow up
Time frame: From week 1 day 1 of treatment to week 26.
Change in Tobacco Craving Questionnaire-Short Form (TCQ-SF) Total Score (Units on a Scale)
Time frame: From baseline to week 26.
Change in Dependence Severity (Units on a Scale)
Time frame: From baseline to week 26.
Change in Daily Cigarette Use (Number of Cigarettes per Day)
Time frame: From baseline to week 26.
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 21 Apr 2026.
- Individual participant dataSharing planned: No. There are no plans for use of your study data in other research.
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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.
Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS principal investigator
Waypoint Centre for Mental Health Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bilateral deep accelerated repetitive transcranial magnetic stimulation in people with Tobacco Use Disorder and Addiction Nicotine, run by Waypoint Centre for Mental Health Care at 2 sites 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 7 inclusion and 10 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Florence Tang, MA (705-549-3181 ext. 3040, ftang@waypointcentre.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects (time frame: From week 1 day 1, to week 1 day 5 of treatment week.). The study lists 4 primary outcomes in all. 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 21 Apr 2026.