Accelerated dTMS Smoking Cessation

NCT ID: NCT07292883

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2028-01-01

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

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accelerated Repetitive Transcranial Magnetic Stimulation

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

Group Type: EXPERIMENTAL

Bilateral deep accelerated repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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).

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).

Intervention Type: DEVICE

Other Intervention Names

Deep TMS; Accelerated TMS; Repetitive TMS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Waypoint Centre for Mental Health Care

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Waypoint Centre for Mental Health Care

Locations

Waypoint Centre for Mental Health Care

Penetanguishene, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Florence Tang, MA

Role: CONTACT

Phone: 705-549-3181

Email: ftang@waypointcentre.ca

Vincent Wang, MD

Role: CONTACT

Phone: 647-522-3415

Email: xi-yu.wang@camh.ca

Facility Contacts

Florence Tang, Masters of Arts

Role: primary

Vincent Wang, MD

Role: backup

Florence Tang, Masters of Arts

Role: primary

Vincent Wang, MD

Role: backup

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5240

Identifier Type: -

Identifier Source: org_study_id