Accelerated dTMS Smoking Cessation

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:

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 Overview

• Status: Recruiting
• Conditions: Tobacco Use Disorder; Addiction Nicotine
• Intervention / Treatment: Device: Bilateral deep accelerated repetitive transcranial magnetic stimulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Florence Tang, MA; Phone Number: 3040 705-549-3181; Email: ftang@waypointcentre.ca
• Study Contact Backup: Name: Vincent Wang, MD; Phone Number: 647-522-3415; Email: xi-yu.wang@camh.ca

Study Locations

• Canada
  • Ontario
    • Penetanguishene, Ontario, Canada
      • Recruiting
      • Waypoint Centre for Mental Health Care
      • Contact: Florence Tang, Masters of Arts; Phone Number: 3040 705-549-3181; Email: ftang@waypointcentre.ca
      • Contact: Vincent Wang, MD; Phone Number: 3040 647-522-3415; Email: xi-yu.wang@camh.ca
      • Principal Investigator: Plabon Ismail, MD
    • Toronto, Ontario, Canada
      • Not yet recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Vincent Wang, MD; Phone Number: 647-522-3415; Email: xi-yu.wang@camh.ca
      • Contact: Florence Tang, Masters of Arts; Phone Number: 3040 705-549-3181; Email: ftang@waypointcentre.ca
      • Principal Investigator: Peter Peter Giacobbe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 years or older;
2. Tobacco use disorder as assessed by DSM-5;
3. Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
4. Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7;
5. Must sign and date the informed consent form;
6. Stated willingness to comply with all study procedures.
7. Able to communicate in English.

Exclusion Criteria:

1. Reported smoking abstinence in the 3 months preceding screening visit;
2. Current use of other smoking cessation aids;
3. Contraindication to rTMS;
4. Pregnancy, trying to become pregnant or breastfeeding;
5. Current or recent history of cerebrovascular disease;
6. Unstable major psychiatric disorder(s) (i.e. Axis I Disorders) that would prevent participation in the study at PI (or its delegate) discretion;
7. 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;
8. Current, personal history or family history of seizures;
9. Concomitant use of medication that lowers seizure threshold, such as clozapine;
10. Concomitant use of more than 2 mg lorazepam (or an equivalent) or any anticonvulsants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Accelerated Repetitive Transcranial Magnetic Stimulation; 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).; Other Names: Repetitive TMS; Deep TMS; Accelerated TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From week 1 day 1, to week 1 day 5 of treatment week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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).	From baseline to week 26.

Collaborators and Investigators

• Sponsor: Waypoint Centre for Mental Health Care
• Investigators: Principal Investigator: Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS, Waypoint Centre for Mental Health Care

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: addiction; smoking cessation; Transcranial Magnetic Stimulation; Accelerated Repetitive Transcranial Magnetic Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Health Behavior; Tobacco Use Disorder; Behavior, Addictive; Smoking Cessation
• Other Study ID Numbers: 5240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans for use of your study data in other research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No