Study of Brain Stimulation Using iTBS to Reduce Opioid Craving and Use in Adults with Opioid Use Disorder Taking Buprenorphine

What this Trial Is About

This research investigates how stimulating a specific brain region influences craving and opioid use in people with opioid use disorder OUD. The study focuses on applying intermittent theta burst stimulation iTBS, a form of repetitive transcranial magnetic stimulation rTMS, to the left dorsolateral prefrontal cortex L DLPFC. The goal is to examine whether this brain stimulation can reduce craving and opioid use in individuals currently treated with buprenorphine. The study also explores brain changes using optional magnetic resonance imaging MRI. Participants will receive 8 weekly sessions of FDA-approved L DLPFC-targeted iTBS or sham stimulation, with two iTBS sessions per visit separated by 50 minutes. Before treatment, individuals are randomly assigned to active or sham groups, where sham involves flipping the coil to mimic the procedure without actual brain stimulation. Optional MRI scans are offered before the first iTBS session and after completion of the 8-week intervention to assess brain connectivity and activity. Follow-up visits occur at weeks 10, 12, and 20 to monitor outcomes. During the study, participants attend 12 visits over about 5 months, each lasting 1 to 2 hours. They complete interviews, questionnaires about opioid use and psychiatric symptoms, and urine toxicology tests. Optional MRI visits include cognitive tasks and brain imaging. Safety is monitored through medical history assessments and specific screening questionnaires. The main measurements focus on changes in craving using the Opioid Craving Scale and brain connectivity changes via MRI. Participants who initially receive sham stimulation are offered active iTBS after the study concludes.

Vanderbilt Integrated Community TMS for Opioid Recovery