Clinical Trial

Focused Ultrasound for the Complex Patient

Study acronym: LIFU
Recruiting
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Record status
This record was last updated November 20, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\[s\] it aims to answer are: * the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain * the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-05; most recent amendment 2024-11-15.
Trial Details
NCT Number NCT06453109
Lead Sponsor Washington D.C. Veterans Affairs Medical Center
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Conditions Opioid Use Disorder, Chronic Back Pain, Anxiety
Enrollment 25 participants
Start Date 2024-04-29
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-20