Transcranial Magnetic Stimulation for Smoking Addiction

Overseen By Victor M Tang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Centre for Addiction and Mental Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Victor M Tang, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who smoke daily, want to quit within the next month, and are considering rTMS or nicotine replacement as treatment. They must be able to consent and have a psychiatric disorder like depression, anxiety, PTSD, OCD, schizophrenia or another substance use disorder.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.

I smoke cigarettes daily.

I have been diagnosed with a mental health condition like depression, anxiety, or PTSD.

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study tests if brain stimulation with Brainsway H4 deep rTMS coil is more effective than usual treatments for smoking cessation in patients with mental illness. It also explores how feasible and acceptable this new method is in clinical care settings.

How Is the Trial Designed?

Group I: Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention Experimental Treatment 1 Intervention

Treatment course consisting of daily treatment, 5 days per week, for 3 weeks, followed by once weekly treatments for 3 weeks, for a total of 18 treatment sessions over 6 weeks.

Group II: Treatment as Usual Active Control 1 Intervention

Treatment with Nicotine Replacement Therapy (NRT) and/or adjunctive counselling will be provided by their clinical team through the Smoking Treatment for Ontario Patients (STOP) Program. All treatments will be delivered by study physicians in the Nicotine Dependence Clinic at CAMH, all of whom administer NRT through the STOP program.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+