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Accelerated dTMS Smoking Cessation

Accelerated dTMS Smoking Cessation

Recruiting
18 years and older
All
Phase 2

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Overview

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.

Eligibility

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 details
    Tobacco Use Disorder
    Addiction Nicotine

NCT07292883

Waypoint Centre for Mental Health Care

13 May 2026

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