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.

Authors

Kathryn Biernacki, Jillian Connolly, Libby Tunison, Kristopher A Kast, Simon Vandekar, Benson King, Tashley Aouina, Beth Black, Rachel Craig, Jason Ferrell, Christopher A Grimes, Lauren Horowitz, Michael Levin, Mariah Smith, Linda Sok, Amanda von Horn, Kyle York, Steven Somers, Jonathan Becker, Michelle Cochran, Heather Burrell Ward

Published in

PloS one. Volume 21. Issue 9. Pages e0357402. Epub Sep 10, 2026.

Abstract

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.
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.
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.
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.
This clinical trial is registered at ClinicalTrials.Gov; ID NCT07457489; date of registration: 03/02/2026.

PMID:
42721136
Bibliographic data and abstract were imported from PubMed on 11 Sep 2026.

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