NCT07292883

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
21mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Jan 2028

First Submitted

Initial submission to the registry

November 20, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 21, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

November 20, 2025

Last Update Submit

April 15, 2026

Conditions

Tobacco Use DisorderAddiction Nicotine

Keywords

addictionsmoking cessationTranscranial Magnetic StimulationAccelerated Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • The percentage of participants achieving continuous short-term abstinence at follow up

    From week 1 day 5 of treatment to week 26.

  • The percentage of participants achieving continuous long-term abstinence at follow up

    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)

    From baseline to week 26.

  • Change in Dependence Severity (Units on a Scale)

    From baseline to week 26.

  • Change in Daily Cigarette Use (Number of Cigarettes per Day)

    From baseline to week 26.

Study Arms (1)

Accelerated Repetitive Transcranial Magnetic Stimulation

EXPERIMENTAL

Bilateral Accelerated Repetitive Transcranial Magnetic Stimulation targeting the insula and prefrontal cortex using H4 coil

Device: Bilateral deep accelerated repetitive transcranial magnetic stimulation

Interventions

Bilateral deep accelerated repetitive transcranial magnetic stimulationDEVICE

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
Accelerated Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Waypoint Centre for Mental Health Care

Penetanguishene, Ontario, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Tobacco Use DisorderBehavior, AddictiveSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorHealth Behavior

Study Officials

  • Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS

    Waypoint Centre for Mental Health Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Tang, MA

CONTACT

705-549-3181ftang@waypointcentre.ca

Vincent Wang, MD

CONTACT

647-522-3415xi-yu.wang@camh.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 18, 2025

Study Start

February 24, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

April 21, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

There are no plans for use of your study data in other research.

Locations

CA(2)