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Accelerated dTMS Smoking Cessation

NCT07292883 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-21

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Waypoint Centre for Mental Health Care

    lead OTHER

Principal Investigators

  • Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS · Waypoint Centre for Mental Health Care

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-24
Primary Completion
2028-01-31
Completion
2028-01-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292883 on ClinicalTrials.gov