Implementation of Transcranial Magnetic Stimulation for Smoking Cessation
ConditionSmoking
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre for Addiction and Mental Health
About this trial
Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.
The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.
Participants will be asked to come to CAMH to:
* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment * Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.
Objectives
• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Smoking cigarettes daily (self-reported)
Currently employed as a HCP (physician, social worker, occupational therapist, etc.) at the CAMH NDC
Involved in the care of at least 1 patient who has received rTMS for smoking cessation
Disqualifiers
Have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
Pregnant or intending to be pregnant during the study.
A history of a primary seizure disorder, seizure associated with an intracranial lesion, recurrent seizures related to substance intoxication or withdrawal or recent seizure within the last 6 months.
Taking any anticonvulsant medication unless it cannot be tapered or discontinued due to risk of clinical safety or destabilization, according to the participant or their referring physician.
Trial design
Design model
Single group
Treatments tested in this trial
Brainsway H4 deep rTMS coil and Brainsway stimulator system
DeviceAn 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 PowerPoint 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 from the NDC.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Patients Receiving rTMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The primary objective of the study is to evaluate the feasibility of implementing rTMS in the Nicotine Dependence Clinic (NDC) at CAMH, in Toronto. This is determine by reach, the extent to which patients are engaging in the rTMS treatment.
The proportion of patients accepting rTMS relative to all patients with a visit to the NDC during the study period.
Time frame
Through study completion, an average of 1 year2
Identify rates of adoption of rTMS in Nicotine Dependence Clinic
What percentage of NDC HCPs refer patients to rTMS treatment? (Adoption)
Time frame
Through study completion, an average of 1 year3
Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach.
Research questions assessed through through surveys and semi-structured interviews 1. What are the multi-level barriers and facilitators to integrating rTMS in NDC? 2. How acceptable, appropriate and feasible is it to integrate rTMS in NDC?
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC.
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).
Time frame
Through study completion, an average of 1 year2
Explore patient-HCP communication about shared treatment decision-making for rTMS.
We will conduct semi-structured interviews with NDC patients and HCPs to better understand the collaborative nature and necessary communication components involved in shared treatment decision-making for rTMS.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov