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Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial

StatusRecruiting
PhasePhase 4
Started2024-09-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 11, 2025 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-12-05
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-08-01→2026-09-01
Completion date2026-09-01→2026-12-01
Study sites0→1
2024-07-31
minor
Original filing
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Additionally, tobacco use is substantially higher in individuals with comorbid mental illness, constituting a particularly vulnerable population. As such, the development of multiple evidence-based treatments for smoking cessation is of upmost importance. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of substance use disorders. Recently, a deep TMS coil has been cleared by the Food and Drug Administration (FDA) as efficacious for tobacco use disorder, representing the first rTMS indication for addictions. Before adoption of this intervention into smoking cessation clinics, it is important to investigate whether implementation of rTMS into clinical care is feasible, acceptable, and appropriate for patients receiving care for nicotine dependence. The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation. Also, barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS.
Trial Details
NCT Number NCT06534047
Lead Sponsor Centre for Addiction and Mental Health
Conditions Tobacco Use Disorder, Psychiatric Disorder, Nicotine Dependence
Enrollment 40 participants
Start Date 2024-09-01
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-11