Accelerated bilateral deep TMS to help adults quit smoking
Accelerated Deep Transcranial Magnetic Stimulation for Smoking Cessation
This will try a 5-day course of bilateral accelerated deep transcranial magnetic stimulation to help adults with tobacco use disorder quit smoking.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Waypoint Centre for Mental Health Care Academic / other |
| Locations | 2 sites (Penetanguishene, Ontario and 1 other locations) |
| Trial ID | NCT07292883 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study delivers bilateral accelerated deep rTMS with four sessions per day over five consecutive days to adults 18–65 who meet criteria for tobacco use disorder. The trial plans to enroll about 30–40 participants and will focus on feasibility measures including tolerability, acceptability, participant retention, and adherence to scheduled sessions. Smoking outcomes such as point-prevalence and prolonged abstinence are tracked at end of treatment and at several follow-up weeks to explore preliminary efficacy. Common exclusions include recent abstinence, current use of other cessation aids, pregnancy or breastfeeding, contraindications to rTMS, and unstable major psychiatric or neurological conditions.
Who should consider this trial
Good fit: Adults aged 18–65 with DSM-5 tobacco use disorder, moderate-to-high nicotine dependence (FTND ≥ 4), motivated to quit within 30 days (Contemplation Ladder ≥ 7), able to communicate in English, and without contraindications to rTMS are ideal candidates.
Not a fit: People who have been abstinent in the prior 3 months, are currently using other smoking-cessation aids, are pregnant or breastfeeding, have contraindications to rTMS, or have unstable major psychiatric or neurological disorders may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a short, clinic-based, intensive option to help some people stop smoking with a single 5-day regimen.
How similar studies have performed: Previous rTMS and dTMS studies for smoking have shown modest benefits, but the accelerated bilateral deep TMS protocol delivered over one week is relatively novel and has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Penetanguishene, Ontario and 1 other locations
- Waypoint Centre for Mental Health Care — Penetanguishene, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS — Waypoint Centre for Mental Health Care
- Study coordinator: Florence Tang, MA
- Email: ftang@waypointcentre.ca
- Phone: 705-549-3181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.