Actively Recruiting
LIFU for Treatment for Refractory Opioid Use Disorder
Led by Ali Rezai · Updated on 2026-02-17
34
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
A
Ali Rezai
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
LIFU for Treatment for Refractory Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 22 - 60 years at time of enrollment.
- Meet current DSM-5 criteria for severe opioid use disorder with at least a 2-year history.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
You will not qualify if you...
- Unable to have MRI due to non-compatible implants, claustrophobia, or inability to lie still on back for 2-3 hours.
- History of significant neurological disorders such as brain surgery, tumors, or uncontrolled epilepsy.
- History of stroke or brain lesion in the targeted brain areas (nucleus accumbens, ventral striatum, or ventral capsule).
- Have implanted neurostimulators like vagus nerve or spinal cord stimulators.
- Clinically significant MRI abnormalities that pose safety risks or affect study assessments.
- More than 30% of skull area in sonication path covered by scars, scalp disorders, or atrophy.
- Chronic severe pulmonary disorders like emphysema or pulmonary vasculitis.
- Impaired kidney function with estimated glomerular filtration rate below 30 mL/min/1.73m2.
- Elevated liver function tests over 1.5 times normal unless deemed not significant.
- Past or current diagnosis of schizophrenia or psychotic disorder.
- Unwillingness to attempt abstinence from illicit substances during the study.
- Unable to speak, read, and understand English.
- Considered a poor surgical or study candidate due to medical, social, or psychological issues.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
J
James Mahoney
CONTACT
J
Jennifer Marton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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