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LIFU for Refractory Opioid Use Disorder

This study is testing a treatment called Low Intensity Focused Ultrasound (LIFU) for people with severe opioid use disorder (OUD) that hasn't responded to other treatments. LIFU uses sound waves to target specific areas of the brain. The main goals are to see if LIFU is safe, how well people tolerate it, and if it can help reduce opioid and other substance use. You could be eligible if you are between 22 and 60 years old and have a severe OUD diagnosis for at least two years. The study will follow participants for 90 days after receiving LIFU to check for side effects and changes in opioid use. The current status of the study is unclear.

Study design
This is a randomized, double-blind study, meaning some participants will receive LIFU and others a sham (inactive) treatment, and neither you nor the researchers will know which you received. It plans to enroll 34 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 90 days after the LIFU procedure to monitor for side effects and changes in opioid use.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06218706

LIFU for Treatment for Refractory Opioid Use Disorder

Recruiting
NAAges 22–60InterventionalTreatment
Ali Rezai
~34 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Low Intensity Focussed Ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Treatment Emergent Adverse Events
Measured over Post-ExAblate Procedure through 90 day Follow-Up
+1 more outcome measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Ali Rezai · PRINCIPAL_INVESTIGATOR · Executive Director WVU Rockefeller Neuroscience Institute

Who to contact

James Mahoney
[email protected]
3042935323
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Occurrence of Treatment Emergent Adverse EventsPost-ExAblate Procedure through 90 day Follow-Up

    Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurrence.

  • Changes in Opioid UsePost-ExAblate Procedure through 90 day Follow-Up

    Changes in opioid use will be measured using quantitative urine toxicology via liquid chromatography/mass spectrometry (LC/MS).