Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial
NCT Number: NCT06534047
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Tobacco Use Disorder|Psychiatric Disorder|Nicotine Dependence
Interventions: DEVICE: Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil|DRUG: Nicotine replacement
Sponsor: Centre for Addiction and Mental Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01

Summary:
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.

Primary Outcome Measures: Evaluate the feasibility of conducting a pragmatic, hybrid effectiveness implementation trial of Repetitive Transcranial Magnetic Stimulation (rTMS) versus treatment as usual (TAU)., Recruitment over the 2-year study period will be measured, with a target sample of 40. Retention will be determined by the proportion of people who complete 50% of the treatments., Through study completion, an average of 2 years
Secondary Outcome Measures: Estimate the difference in effectiveness between Repetitive Transcranial Magnetic Stimulation (rTMS) and Treatment As Usual (TAU) on smoking cessation rates in real world patients with psychiatric comorbidities., Self-reported 4-week continuous quit rate and long follow-up continuous quit rate (biochemically verified by urine nicotine/tobacco metabolite collection and analysis at end of treatment and the long follow-up)., After completion of the intervention (rTMS or TAU; up to 6 weeks)|Estimate the implementation of Repetitive Transcranial Magnetic Stimulation (rTMS) in routine clinical care., Semi-structured interviews with NDC patients and healthcare providers to better understand the collaborative nature and necessary communication components involved in shared treatment decision-making for rTMS., Through study completion, an average of 2 years