NCT07292883 Accelerated dTMS Smoking Cessation
| NCT ID | NCT07292883 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Waypoint Centre for Mental Health Care |
| Condition | Tobacco Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2028-01 |
Trial Parameters
Eligibility Fast-Check
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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.
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 l