A Phase 2 interventional study of Bilateral deep accelerated repetitive transcranial magnetic stimulation in Tobacco Use Disorder and Addiction Nicotine, sponsored by Waypoint Centre for Mental Health Care. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Waypoint Centre for Mental Health Care · Phase 2, Interventional, and Treatment
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:
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 40 is below the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Waypoint Centre for Mental Health Care is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilateral Accelerated Repetitive Transcranial Magnetic Stimulation targeting the insula and prefrontal cortex using H4 coil
Device: Bilateral deep accelerated repetitive transcranial magnetic stimulation
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).
Also known as: Deep TMS, Accelerated TMS, Repetitive TMS
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From week 1 day 1, to week 1 day 5 of treatment week.
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.
Time frame: 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).
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)
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).
Time frame: 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).
Time frame: 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).
Time frame: From baseline to week 26.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There are no plans for use of your study data in other research.
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Waypoint Centre for Mental Health Care