Vanderbilt Integrated Community TMS for Opioid Recovery (VICTORY): Study protocol for a randomized, controlled trial of non-invasive brain stimulation to reduce craving in people with opioid use disorder
- 1Department of Psychiatry & Behavioral Sciences, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America
- 2Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America
- 3Synaptic PSYCH, Brentwood, Tennessee, United States of America
Abstract
Background: Individuals receiving buprenorphine treatment for opioid use disorder (OUD) remain at high risk for treatment discontinuation and return to opioid use. Transcranial magnetic stimulation (TMS) has shown efficacy in reducing craving and substance use in other substance use disorders, but its application in OUD remains limited and the neural mechanism underlying its therapeutic effects is poorly understood. Determining the feasibility and generalizability of TMS in patients receiving buprenorphine – the most commonly prescribed medication for OUD – is therefore critical. This protocol aims to address these issues in a clinical trial of weekly TMS sessions for OUD. Methods: We will enroll up to 120 individuals with OUD taking buprenorphine in a randomized, single-blind, sham-controlled trial of left dorsolateral prefrontal cortex (DLPFC)-targeted intermittent theta burst stimulation (iTBS). Participants will receive active or sham iTBS weekly (2 sessions of 1800 pulses each applied once per week x 8 weeks, 16 sessions total) with pre- and post-iTBS assessments (10, 12, 20 weeks) of craving, opioid use, and treatment retention. A subset of individuals will undergo optional pre- and post-iTBS neuroimaging. The study will be conducted at an academic medical center and a private outpatient TMS clinic. Aims: Our primary aim is to determine whether 16 sessions of active iTBS applied to the left DLPFC results in reduced craving and opioid use, and higher treatment retention, relative to sham. In a secondary aim, we will also examine whether iTBS-related changes in craving are associated with changes in functional connectivity between the left DLPFC and both the dorsal striatum and anterior cingulate cortex. Discussion: By evaluating the feasibility and efficacy of a weekly TMS protocol that aligns with routine care and focuses on patients maintained on buprenorphine, this study addresses key limitations of prior TMS research in OUD. Furthermore, the inclusion of neuroimaging will help characterize the neural mechanisms underlying TMS-related changes in craving. Trial registration: This clinical trial is registered at ClinicalTrials.Gov; ID NCT07457489; date of registration: 03/02/2026.
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BibTeX
@article{biernacki2026vanderbilt,
title = {{Vanderbilt Integrated Community TMS for Opioid Recovery (VICTORY): Study protocol for a randomized, controlled trial of non-invasive brain stimulation to reduce craving in people with opioid use disorder}},
author = {Kathryn Biernacki and Jillian Connolly and Libby Tunison and Kristopher A. Kast and Simon Vandekar and Benson King and Tashley Aouina and Beth Black and Rachel Craig and Jason Ferrell and Christopher A. Grimes and Lauren Horowitz and Michael Levin and Mariah Smith and Linda Sok and Amanda von Horn and Kyle York and Steven Somers and Jonathan Becker and Michelle Cochran and Heather Burrell Ward},
journal = {PLOS One},
year = {2026},
month = sep,
doi = {10.1371/journal.pone.0357402},
url = {https://doi.org/10.1371/journal.pone.0357402},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Vanderbilt Integrated Community TMS for Opioid Recovery (VICTORY): Study protocol for a randomized, controlled trial of non-invasive brain stimulation to reduce craving in people with opioid use disorder
AU - Kathryn Biernacki
AU - Jillian Connolly
AU - Libby Tunison
AU - Kristopher A. Kast
AU - Simon Vandekar
AU - Benson King
AU - Tashley Aouina
AU - Beth Black
AU - Rachel Craig
AU - Jason Ferrell
AU - Christopher A. Grimes
AU - Lauren Horowitz
AU - Michael Levin
AU - Mariah Smith
AU - Linda Sok
AU - Amanda von Horn
AU - Kyle York
AU - Steven Somers
AU - Jonathan Becker
AU - Michelle Cochran
AU - Heather Burrell Ward
PY - 2026
DA - 2026/09/10
JO - PLOS One
DO - 10.1371/journal.pone.0357402
UR - https://doi.org/10.1371/journal.pone.0357402
AB - Background: Individuals receiving buprenorphine treatment for opioid use disorder (OUD) remain at high risk for treatment discontinuation and return to opioid use. Transcranial magnetic stimulation (TMS) has shown efficacy in reducing craving and substance use in other substance use disorders, but its application in OUD remains limited and the neural mechanism underlying its therapeutic effects is poorly understood. Determining the feasibility and generalizability of TMS in patients receiving buprenorphine – the most commonly prescribed medication for OUD – is therefore critical. This protocol aims to address these issues in a clinical trial of weekly TMS sessions for OUD. Methods: We will enroll up to 120 individuals with OUD taking buprenorphine in a randomized, single-blind, sham-controlled trial of left dorsolateral prefrontal cortex (DLPFC)-targeted intermittent theta burst stimulation (iTBS). Participants will receive active or sham iTBS weekly (2 sessions of 1800 pulses each applied once per week x 8 weeks, 16 sessions total) with pre- and post-iTBS assessments (10, 12, 20 weeks) of craving, opioid use, and treatment retention. A subset of individuals will undergo optional pre- and post-iTBS neuroimaging. The study will be conducted at an academic medical center and a private outpatient TMS clinic. Aims: Our primary aim is to determine whether 16 sessions of active iTBS applied to the left DLPFC results in reduced craving and opioid use, and higher treatment retention, relative to sham. In a secondary aim, we will also examine whether iTBS-related changes in craving are associated with changes in functional connectivity between the left DLPFC and both the dorsal striatum and anterior cingulate cortex. Discussion: By evaluating the feasibility and efficacy of a weekly TMS protocol that aligns with routine care and focuses on patients maintained on buprenorphine, this study addresses key limitations of prior TMS research in OUD. Furthermore, the inclusion of neuroimaging will help characterize the neural mechanisms underlying TMS-related changes in craving. Trial registration: This clinical trial is registered at ClinicalTrials.Gov; ID NCT07457489; date of registration: 03/02/2026.
SN - 1932-6203
ER -