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Recruiting Phase 2 NCT07292883

Accelerated dTMS Smoking Cessation

Phase 2 – studying effectiveness and dosage
Conditions: Tobacco Use Disorder Addiction Nicotine

Sponsor: Waypoint Centre for Mental Health Care

trial.available_in: БГ
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.
Who can participate
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.
Interventions
Bilateral deep accelerated repetitive transcranial magnetic stimulation
DEVICE
Locations 2
Canada (2)
Waypoint Centre for Mental Health Care
Penetanguishene , Ontario
Florence Tang, Masters of Arts
Sunnybrook Health Sciences Centre
Toronto , Ontario
NOT_YET_RECRUITING
Florence Tang, Masters of Arts
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.02.2026
Completion date
01.01.2028
Registry ID
NCT07292883
Source
clinicaltrials.gov
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