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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-02-24 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS
PRINCIPAL INVESTIGATOR
Waypoint Centre for Mental Health Care
Frequently Asked Questions
Who can join the NCT07292883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07292883 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07292883 currently recruiting?
Yes, NCT07292883 is actively recruiting participants. Contact the research team at ftang@waypointcentre.ca for enrollment information.
Where is the NCT07292883 trial being conducted?
This trial is being conducted at Penetanguishene, Canada, Toronto, Canada.
Who is sponsoring the NCT07292883 clinical trial?
NCT07292883 is sponsored by Waypoint Centre for Mental Health Care. The principal investigator is Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS at Waypoint Centre for Mental Health Care. The trial plans to enroll 40 participants.