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

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.

Conditions

• Tobacco Use Disorder
• Psychiatric Disorder
• Nicotine Dependence

Interventions

DEVICE

Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil

An rTMS 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. Sixty trains of 30 pulses each (total 1,800 pulses) will be applied at 10 Hz, for 3 second trains, with a 15 second inter-train interval, for approximately 18 minutes of treatment time. At each rTMS treatment session, prior to stimulation, participants will undergo a smoking craving provocation procedure where they will be asked to close their eyes and imagine one of their triggers for 30 seconds. Following this they will watch a presentation of smoking pictures for 2 minutes and 30 seconds. Thus, the entire craving provocation procedure will be 3 minutes prior to stimulation start. Brief behavioural support will be available to the participant on a weekly basis by a trained research staff member.

DRUG

Nicotine replacement

Each participant will receive individualized NRT treatment through the advice of their study physician for 6 weeks. The study physician, in discussion with the participant, will decide the type, dosage, and combination of NRT to provide to the participant. NRT provided can include: * Patch (7mg, 14mg, and 21mg) * Gum (2mg) * Lozenge (2mg) * Inhaler (10mg; 4mg of nicotine delivered)

Sponsors & Collaborators

• Centre for Addiction and Mental Health

  lead OTHER

Principal Investigators

• Victor M Tang, MD · Centre for Addiction and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2026-09-01

Completion

2026-12-01

FDA Device

Yes

Countries

• Canada

Study Locations