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Multimodal smoking cessation treatment combining repetitive transcranial magnetic stimulation, cognitive behavioral therapy, and nicotine replacement in veterans with posttraumatic stress disorder: A feasibility randomized controlled trial protocol

Title: Multimodal smoking cessation treatment combining repetitive transcranial magnetic stimulation, cognitive behavioral therapy, and nicotine replacement in veterans with posttraumatic stress disorder: A feasibility randomized controlled trial protocol
Authors: Young, Jonathan R.; Polick, Carri S.; Michael, Andrew M.; Dannhauer, Moritz; Galla, Jeffrey T.; Evans, Mariah K.; Troutman, Addison; Kirby, Angela C.; Dennis, Michelle F.; Papanikolas, Claire W.; Deng, Zhi-De; Moore, Scott D.; Dedert, Eric A.; Addicott, Merideth A.; Appelbaum, Lawrence G.; Beckham, Jean C.
Contributors: Oathes, Desmond J.; U.S. Department of Veterans Affairs; National Institute of Mental Health
Source: PLOS ONE ; volume 19, issue 9, page e0291562 ; ISSN 1932-6203
Publisher Information: Public Library of Science (PLoS)
Publication Year: 2024
Collection: PLOS Publications (via CrossRef)
Description: Tobacco-related deaths remain the leading cause of preventable death in the United States. Veterans suffering from posttraumatic stress disorder (PTSD)—about 11% of those receiving care from the Department of Veterans Affairs (VA)—have triple the risk of developing tobacco use disorder (TUD). The most efficacious strategies being used at the VA for smoking cessation only result in a 23% abstinence rate, and veterans with PTSD only achieve a 4.5% abstinence rate. Therefore, there is a critical need to develop more effective treatments for smoking cessation. Recent studies suggest the insula is integrally involved in the neurocircuitry of TUD. Thus, we propose a feasibility phase II randomized controlled trial (RCT) to study a form of repetitive transcranial magnetic stimulation (rTMS) called intermittent theta burst stimulation (iTBS). iTBS has the advantage of allowing for a patterned form of stimulation delivery that we will administer at 90% of the subject’s resting motor threshold (rMT) applied over a region in the right post-central gyrus most functionally connected to the right posterior insula. We hypothesize that by increasing functional connectivity between the right post-central gyrus and the right posterior insula, withdrawal symptoms and short-term smoking cessation outcomes will improve. Fifty eligible veterans with comorbid TUD and PTSD will be randomly assigned to active-iTBS + cognitive behavioral therapy (CBT) + nicotine replacement therapy (NRT) ( n = 25) or sham-iTBS + CBT + NRT ( n = 25). The primary outcome, feasibility, will be determined by achieving a recruitment of 50 participants and retention rate of 80%. The success of iTBS will be evaluated through self-reported nicotine use, cravings, withdrawal symptoms, and abstinence following quit date (confirmed by bioverification) along with evaluation for target engagement through neuroimaging changes, specifically connectivity differences between the insula and other regions of interest.
Document Type: article in journal/newspaper
Language: English
DOI: 10.1371/journal.pone.0291562
Availability: https://doi.org/10.1371/journal.pone.0291562; https://dx.plos.org/10.1371/journal.pone.0291562
Rights: https://creativecommons.org/publicdomain/zero/1.0/
Accession Number: edsbas.4E3B77A
Database: BASE