LIFU for Treatment for Refractory Opioid Use Disorder

NCT06218706 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Ali Rezai

    lead OTHER

Principal Investigators

  • Ali Rezai · Executive Director WVU Rockefeller Neuroscience Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2026-10-30
Completion
2028-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218706 on ClinicalTrials.gov