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Opioid Use DisorderPainAddictionMental healthDevice

What this study is

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.

What's being tested

  • low intensity focused ultrasound (LIFU)

    Intervention · DEVICE

    Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.

Study details

Official title
Towards Treatment of the Complex Patient: Investigations of Low-intensity Focused Ultrasound
Sponsor
Washington D.C. Veterans Affairs Medical Center
Conditions
Opioid Use Disorder · Chronic Back Pain · Anxiety
Enrolling
25 people
Starts
2024-04-29
Est. completion
2025-09-30
Design
Double-blind, randomized, crossover
Record
View on ClinicalTrials.gov ↗