Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre for Addiction and Mental Health
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide informed consent.
Age 18-70.
Self-reported daily tobacco cigarette consumption.
Meet DSM-5 criteria for a psychiatric disorder that includes one of the following: mood disorders (e.g. major depressive disorder, bipolar disorder), anxiety disorders (e.g. panic disorder, social anxiety disorder), psychotic disorders (e.g. schizophrenia), posttraumatic stress disorder, obsessive compulsive disorders, or other substance use disorders (e.g. alcohol use disorder) as determined by the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5 RV).
Disqualifiers
Contraindication to rTMS according to the TMS Adult Safety Screen (TASS) and PI review.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil
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 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.
Nicotine replacement
DrugEach 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)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Repetitive Transcranial Magnetic Stimulation (rTMS) InterventionExperimental treatment 1 intervention
Group B: Treatment as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
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).
Time frame
After completion of the intervention (rTMS or TAU; up to 6 weeks)2
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.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov