LIFU for Treatment for Refractory Opioid Use Disorder

A Randomized, Sham-Controlled Trial Investigating Low Intensity Focused Ultrasound as a Novel Treatment for Refractory Opioid Use Disorder

This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: Low Intensity Focussed Ultrasound

Detailed Description

The overall objective of this study is to assess the safety, tolerability, and feasibility of using Low Intensity Focused Ultrasound (LIFU) to treat opioid use disorder (OUD) as well as investigate the potential impact on substance use and risk factors associated with drug use recurrence.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Mahoney; Phone Number: 3042935323; Email: jsmes.mahoney@hsc.wvu.edu
• Study Contact Backup: Name: Jennifer Marton; Phone Number: 3042935886; Email: jennifer.marton@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • WVU Rockefeller Neuroscience Institute
      • Contact: James Mahoney, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 22 - 60 years at time of enrollment.
• Fulfill current DSM-5 (American Psychiatric Association diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for severe OUD with at least a 2-year history.
• Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception.

Exclusion Criteria:

• Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia) or cannot lie comfortably on their back for 2-3 hours.
• History of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator).
• History of stroke or brain lesion in the targeted brain region (the NAc, ventral striatum, or VC).
• Implanted neurostimulators (e.g., vagus nerve stimulator, spinal cord stimulator, DBS).
• Documentation of clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
• More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
• Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
• Subject with impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
• Hepatic function laboratory values which are > 1.5 times the upper limit of normal unless deemed not clinically significant by a study investigator.
• Past or present diagnosis of schizophrenia or psychotic disorder.
• Subject unwilling to attempt abstinence from illicit substance use during the course of the study.
• Unable to speak, read and understand English.
• Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham treatment	Device: Low Intensity Focussed Ultrasound; The major objective of this study is to further test safety, tolerability, and feasibility of LIFU in this population as well as investigate the impact of LIFU on opioid and other substance use. The primary endpoint is 90 days (Post-LIFU Week 12) following Active/Sham LIFU. After the primary endpoint is reached, the blind will be broken and the group who received Sham LIFU will cross-over and receive Active LIFU
Experimental: LIFU Treatment	Device: Low Intensity Focussed Ultrasound; The major objective of this study is to further test safety, tolerability, and feasibility of LIFU in this population as well as investigate the impact of LIFU on opioid and other substance use. The primary endpoint is 90 days (Post-LIFU Week 12) following Active/Sham LIFU. After the primary endpoint is reached, the blind will be broken and the group who received Sham LIFU will cross-over and receive Active LIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Treatment Emergent Adverse Events	Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurrence.	Post-ExAblate Procedure through 90 day Follow-Up
Changes in Opioid Use	Changes in opioid use will be measured using quantitative urine toxicology via liquid chromatography/mass spectrometry (LC/MS).	Post-ExAblate Procedure through 90 day Follow-Up

Collaborators and Investigators

• Sponsor: Ali Rezai
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ali Rezai, Executive Director WVU Rockefeller Neuroscience Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2312890071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes