Recruiting
Phase 2

aTMS

Sponsor:

Waypoint Centre for Mental Health Care

Code:

NCT07292883

Conditions

Tobacco Use Disorder

Addiction Nicotine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bilateral deep accelerated repetitive transcranial magnetic stimulation

Study Details

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.

Conditions

Tobacco Use Disorder

Addiction Nicotine

Study ID

NCT07292883

Start date

Feb 24, 2026

Status verified date

Dec, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated Repetitive Transcranial Magnetic Stimulation

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

Interventions

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).

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. ]
  • TMS Experience Questionnaire Acceptability Scores (Units on a Scale) [ 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 [ Time Frame: From week 1 day 1, to week 5 day 5 of treatment week. ]
  • Percentage of Treatment Sessions Attended [ Time Frame: From week 1 day 1, to week 1 day 5 of treatment week. ]

Central Contacts and Locations

Central contacts

Locations

Waypoint Centre for Mental Health Care

Recruiting

Penetanguishene, Ontario, Canada

Contacts

Florence Tang, Masters of Arts

705-549-3181ftang@waypointcentre.ca

Principal Investigator:

Plabon Ismail, MD

More Information

Sponsor

Waypoint Centre for Mental Health Care

Last update posted

Apr 21, 2026

Last verified

Dec, 2025

Keywords

  • addiction
  • smoking cessation
  • Transcranial Magnetic Stimulation
  • Accelerated Repetitive Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Waypoint Centre for Mental Health Care on 2026-04-21.