Implementation of Transcranial Magnetic Stimulation for Smoking Cessation

Official title

A Pragmatic Feasibility Trial on the Implementation of Transcranial Magnetic Stimulation for Smoking Cessation

Overview

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.

Detailed description

Approximately 45,000 Canadians die from smoking each year and smoking is the leading preventable cause of death worldwide. Quitting smoking is difficult, and current treatments such as varenicline and nicotine replacement therapy are not always able to help people quit.

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.

A landmark 2021 study showed that daily rTMS treatment for 6 weeks targeting these regions is effective at reducing craving and cigarette use. This study's findings provided supporting evidence that led Health Canada and the Food and Drug Administration to approve rTMS as a treatment for smoking cessation. Currently, this treatment is not widely available, therefore it is important to learn more about how to bring it into clinics and develop it further.

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.

The main questions it aims to answer are:

* How many people who are patients at the NDC are interested in this treatment? * How acceptable is this treatment for people who have experienced it? * What factors of this treatment are appealing or unappealing to people? * How well does it work to help people quit smoking? * Who are the main group of people who want this treatment?

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.

Interventions

• Device Brainsway H4 deep rTMS coil and Brainsway stimulator system
  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 t

Primary outcome measures

• 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. [Time frame: Through study completion, an average of 1 year]
• Identify rates of adoption of rTMS in Nicotine Dependence Clinic [Time frame: Through study completion, an average of 1 year]
• Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach. [Time frame: Through study completion, an average of 1 year]

Secondary outcome measures (2)

• Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC. [Time frame: Through study completion, an average of 1 year]
• Explore patient-HCP communication about shared treatment decision-making for rTMS. [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion Criteria: Patients receiving rTMS

• Smoking cigarettes daily (self-reported)

Inclusion Criteria: Health care providers

• 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

Exclusion Criteria: Patients receiving rTMS

• 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.
• Taking benzodiazepines with dose equivalent or greater than lorazepam 2mg/day unless it cannot be tapered or discontinued due to risk of clinical safety or destabilization, according to the participant or their referring physician.
• Space occupying intracranial lesion.
• Acutely unstable medical, psychiatric, or substance use disorder comorbidity with safety concerns at the discretion of the PI or study physician.

Exclusion Criteria: Health care providers

\- There are no exclusion criteria for HCP Participants

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Center for Addiction and Mental Health (CAMH) — Toronto

Publications

• Zangen A, Moshe H, Martinez D, Barnea-Ygael N, Vapnik T, Bystritsky A, Duffy W, Toder D, Casuto L, Grosz ML, Nunes EV, Ward H, Tendler A, Feifel D, Morales O, Roth Y, Iosifescu DV, Winston J, Wirecki T, Stein A, Deutsch F, Li X, George MS. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry. 2021 Oct;2 PMID 34505368
• Ekhtiari H, Tavakoli H, Addolorato G, Baeken C, Bonci A, Campanella S, Castelo-Branco L, Challet-Bouju G, Clark VP, Claus E, Dannon PN, Del Felice A, den Uyl T, Diana M, di Giannantonio M, Fedota JR, Fitzgerald P, Gallimberti L, Grall-Bronnec M, Herremans SC, Herrmann MJ, Jamil A, Khedr E, Kouimtsidis C, Kozak K, Krupitsky E, Lamm C, Lechner WV, Madeo G, Malmir N, Martinotti G, McDonald WM, Montem PMID 31271802
• Miron JP, Jodoin VD, Lesperance P, Blumberger DM. Repetitive transcranial magnetic stimulation for major depressive disorder: basic principles and future directions. Ther Adv Psychopharmacol. 2021 Sep 23;11:20451253211042696. doi: 10.1177/20451253211042696. eCollection 2021. PMID 34589203
• Zhang JJQ, Fong KNK, Ouyang RG, Siu AMH, Kranz GS. Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. Addiction. 2019 Dec;114(12):2137-2149. doi: 10.1111/add.14753. Epub 2019 Aug 16. PMID 31328353
• Seewoo BJ, Hennessy LA, Jaeschke LA, Mackie LA, Etherington SJ, Dunlop SA, Croarkin PE, Rodger J. A Preclinical Study of Standard Versus Accelerated Transcranial Magnetic Stimulation for Depression in Adolescents. J Child Adolesc Psychopharmacol. 2022 Apr;32(3):187-193. doi: 10.1089/cap.2021.0100. Epub 2021 Dec 31. PMID 34978846
• Pushparaj A, Hamani C, Yu W, Shin DS, Kang B, Nobrega JN, Le Foll B. Electrical stimulation of the insular region attenuates nicotine-taking and nicotine-seeking behaviors. Neuropsychopharmacology. 2013 Mar;38(4):690-8. doi: 10.1038/npp.2012.235. Epub 2012 Nov 15. PMID 23249816
• Moretti J, Poh EZ, Rodger J. rTMS-Induced Changes in Glutamatergic and Dopaminergic Systems: Relevance to Cocaine and Methamphetamine Use Disorders. Front Neurosci. 2020 Mar 6;14:137. doi: 10.3389/fnins.2020.00137. eCollection 2020. PMID 32210744
• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on th PMID 31901449

Identifiers

NCT: NCT06346028 · 2023/086

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗