Accelerated bilateral deep TMS to help adults quit smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.