Efficacy of insula deep repetitive transcranial magnetic stimulation combined with varenicline for smoking cessation: A randomized, double-blind, sham controlled trial

Affiliations

¹ Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
² Addictions Division, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada; Institute of Medical Sciences, University of Toronto, Toronto, ON, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
³ Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre of Addiction and Mental Health, Toronto, ON, Canada.
⁴ Canadian Institutes of Health Research, Ottawa, ON, Canada.
⁵ Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.
⁶ Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
⁷ Department of Psychiatry, School of Medicine, University of California, San Diego Health, San Diego, CA, United States.
⁸ Department of Life Sciences and Zelman Centre for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva Israel.
⁹ Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Addictions Division, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada; Institute of Medical Sciences, University of Toronto, Toronto, ON, Canada; Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Acute Care Program, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Waypoint Research Institute, Waypoint Centre for Mental Health Care, Penetanguishene, Ontario, Canada. Electronic address: Bernard.lefoll@camh.ca.

PMID: 37806524
DOI: 10.1016/j.brs.2023.10.002

Free article

Randomized Controlled Trial

Efficacy of insula deep repetitive transcranial magnetic stimulation combined with varenicline for smoking cessation: A randomized, double-blind, sham controlled trial

Christine Ibrahim et al. Brain Stimul. 2023 Sep-Oct.

Free article

. 2023 Sep-Oct;16(5):1501-1509.

doi: 10.1016/j.brs.2023.10.002. Epub 2023 Oct 6.

Authors

Affiliations

¹ Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
² Addictions Division, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada; Institute of Medical Sciences, University of Toronto, Toronto, ON, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
³ Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre of Addiction and Mental Health, Toronto, ON, Canada.
⁴ Canadian Institutes of Health Research, Ottawa, ON, Canada.
⁵ Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.
⁶ Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
⁷ Department of Psychiatry, School of Medicine, University of California, San Diego Health, San Diego, CA, United States.
⁸ Department of Life Sciences and Zelman Centre for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva Israel.
⁹ Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Addictions Division, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada; Institute of Medical Sciences, University of Toronto, Toronto, ON, Canada; Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Acute Care Program, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Waypoint Research Institute, Waypoint Centre for Mental Health Care, Penetanguishene, Ontario, Canada. Electronic address: Bernard.lefoll@camh.ca.

PMID: 37806524
DOI: 10.1016/j.brs.2023.10.002

Abstract

Background: Current smoking cessation treatments are limited in terms of efficacy, particularly with regards to long term abstinence. There is a large amount of evidence implicating the insula in nicotine addiction.

Objective: To examine the efficacy of bilateral repetitive transcranial magnetic stimulation (rTMS) directed to the insular cortex with the H11 coil, relative to sham stimulation, on smoking abstinence and smoking outcomes in smokers who are receiving standard varenicline treatment.

Methods: This randomized, double-blind, sham controlled trial recruited 42 participants who were randomized to receive either active (n = 24) or sham (n = 18) high frequency rTMS directed to the insula (4 weeks), while receiving varenicline treatment (12 weeks). The primary outcome was 7-day point prevalence abstinence at the end of 12 weeks.

Results: Smokers in the active group had significantly higher abstinence rates than those in the sham group (82.4% vs. 30.7%, p = 0.013) at the end of treatment (Week 12). Secondary outcome measures of abstinence rate at the end of rTMS treatment (Week 4), abstinence rate at 6 months, and smoking outcomes (e.g., craving, withdrawal) showed no significant differences between groups. No differences were found in adverse events reported between the groups.

Conclusion: This study provides evidence of the potential benefit of having a combined treatment for smoking cessation using insula rTMS with the H11 coil and varenicline. Maintenance rTMS sessions and continuation of varenicline for those in abstinence may induce longer-term effects and should be considered in future studies.

Keywords: Deep transcranial magnetic stimulation; Insula; Smoking cessation; Tobacco use disorder; Varenicline.

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Conflict of interest statement

Declaration of competing interest BLF has obtained funding from Pfizer Inc. (GRAND Awards, including salary support) for investigator-initiated projects. BLF has obtained funding from Indivior for a clinical trial sponsored by Indivior. BLF has in-kind donations of cannabis products from Aurora Cannabis Enterprises Inc. and study medication donations from Pfizer Inc. (varenicline for smoking cessation) and Bioprojet Pharma. He was also provided a coil for a Transcranial magnetic stimulation (TMS) study from Brainsway. BLF has obtained industry funding from Canopy Growth Corporation (through research grants handled by the Centre for Addiction and Mental Health and the University of Toronto), Bioprojet Pharma, Alcohol Countermeasure Systems (ACS), Alkermes and Universal Ibogaine. Lastly, BLF has received in kind donations of nabiximols from GW Pharmaceuticals for past studies funded by CIHR and NIH. He has participated in a session of a National Advisory Board Meeting (Emerging Trends BUP-XR) for Indivior Canada and is part of Steering Board for a clinical trial for Indivior. He has been consultant for Shinogi. He is supported by CAMH, Waypoint Centre for Mental Health Care, a clinician-scientist award from the department of Family and Community Medicine of the University of Toronto and a Chair in Addiction Psychiatry from the department of Psychiatry of University of Toronto. MSB has received funding from the Brain and Behavior Research Foundation (Formerly NARSAD) and is a full-time employee at Otsuka Canada Pharmaceutical Inc. DMB receives research support from the Canadian Institutes of Health Research (CIHR), National Institutes of Health – US (NIH), Brain Canada Foundation and the Temerty Family through the CAMH Foundation and the Campbell Family Research Institute. He received research support and in-kind equipment support for an investigator-initiated study from Brainsway Ltd. and he was the site principal investigator for three sponsor-initiated studies for Brainsway Ltd. He received in-kind equipment support from Magventure for investigator-initiated studies. He received medication supplies for an investigator-initiated trial from Indivior. He has participated in an advisory board for Janssen. He has participated in an advisory board for Welcony Inc. VMT receives research support through the Brain & Behavior Research Foundation, the Physician Services Incorporated Foundation, Research in Addiction Medicine Scholars (RAMS) Program (R25DA033211) from the National Institute on Drug Abuse, and the Labatt Family Network for Research on the Biology of Depression. ZJD has received research and equipment in-kind support for an investigator-initiated study through Brainsway Inc and Magventure Inc and industry-initiated trials through Magnus Inc. He also currently serves on the scientific advisory board for Brainsway Inc. His work has been supported by the National Institutes of Mental Health (NIMH), the Canadian Institutes of Health Research (CIHR), Brain Canada and the Temerty Family, Grant and Kreutzcamp Family Foundations. AZ is an inventor of Deep TMS coils and has financial interest in BrainsWay which produces and markets these coils. CI, SM, APT, RFT have no conflicts of interests to declare.

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Efficacy of insula deep repetitive transcranial magnetic stimulation combined with varenicline for smoking cessation: A randomized, double-blind, sham controlled trial

Affiliations

Efficacy of insula deep repetitive transcranial magnetic stimulation combined with varenicline for smoking cessation: A randomized, double-blind, sham controlled trial

Authors

Affiliations

Abstract

Conflict of interest statement

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LinkOut - more resources

Full Text Sources

Medical