๐๏ธ Verified NIH Record โข Updated 2026-02-12
LIFU for Treatment for Refractory Opioid Use Disorder (NCT06218706)
๐ข Recruiting Observational / Diagnostic โ๏ธ Medical Device Protocol Sponsor: Ali Rezai
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (14 items).
Location: WVU Rockefeller Neuroscience Institute โ Morgantown, West Virginia
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- WVU Rockefeller Neuroscience Institute โ Morgantown, West Virginia
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.