LIFU for Treatment for Refractory Opioid Use Disorder

NCT06218706 | Recruiting DMC FDA Device

• 1 other identifier: 2312890071
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

LIFU Treatment

EXPERIMENTAL

Device: Low Intensity Focussed Ultrasound

Sham treatment

SHAM COMPARATOR

Device: Low Intensity Focussed Ultrasound

Interventions

Low Intensity Focussed Ultrasound DEVICE

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

LIFU Treatment; Sham treatment

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ali Rezai: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ali Rezai

  Executive Director WVU Rockefeller Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Mahoney

CONTACT

3042935323; jsmes.mahoney@hsc.wvu.edu

Jennifer Marton

CONTACT

3042935886; jennifer.marton@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will occur after all inclusion criteria have been met at which time participants will be randomized 1:1 to either the Active or the Sham arm.This study will be performed in a double-blind manner, with participants as well as investigators and study staff involved with assessments unaware of treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director RNI

Model Details: Randomization will occur after all inclusion criteria have been met at which time participants will be randomized 1:1 to either the Active or the Sham arm. After a participant completes the Week 12 post-LIFU study visit, that participant's treatment assignment is unblinded. Participants randomized to the Sham arm will be crossed over and receive Active LIFU after specified baseline procedures/assessments

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)