Study of Low-intensity Focused Ultrasound to Treat Pain, Anxiety, and Opioid Use Disorder in Adults

What this Trial Is About

This research aims to study the role of the anterior insula AI in pain processing, anxiety, and opiate craving in people with opioid use disorder OUD, chronic back pain, and anxiety disorders. It evaluates whether low-intensity focused ultrasound LIFU, a noninvasive method targeting the AI, is safe and well tolerated compared to sham stimulation. The study addresses the complex interaction of these co-occurring conditions, which are linked to high overdose risk and poor treatment outcomes. Participants undergo one session of either inhibitory LIFU or sham stimulation to the AI in a double-blind, randomized crossover design. LIFU precisely targets the AI with low-intensity ultrasound energy to modulate brain activity without surgery. The study compares LIFUs effects on pain sensitivity, anxiety symptoms, and opiate craving versus sham treatment. The treatment is delivered once per session with monitoring before and within one hour after each session. During the study, participants receive anatomical MRI scans, neurological and clinical assessments, and questionnaires to evaluate safety, tolerability, and treatment effects. Researchers measure adverse events immediately before and after LIFU or sham, as well as heart rate variability and pain thresholds. The total participation includes screening, treatment sessions, and follow-up assessments to gather preliminary data on LIFUs impact on symptoms related to chronic pain, anxiety, and opioid craving.

Focused Ultrasound for the Complex Patient