Actively Recruiting
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
Led by InSightec · Updated on 2026-03-20
29
Participants Needed
4
Research Sites
422 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.
CONDITIONS
Official Title
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and non-pregnant females, age 18 to 60 years old
- Meet DSM-5 criteria for Opioid Use Disorder and/or other Substance Use Disorders including alcohol, with at least two years duration
- Currently receiving outpatient, inpatient, or residential treatment from recognized programs implementing the COAT model or similar
- If prescribed medication for AUD or OUD, on a stable dose for 7 days prior to procedure
- Abstinent from opioids and other illicit substances except cannabis, confirmed by urine toxicology
- Nucleus Accumbens (NAc) visible on MRI for treatment targeting
- Able to communicate sensations during the Exablate Transcranial procedure
- Willing to comply with study requirements and complete all visits
- Able to make own medical decisions as determined by clinical team
- Signed and received copy of informed consent form
You will not qualify if you...
- Taking medications that may adversely interact with MOUD unless investigator approves
- Contraindications for MRI such as non-MRI compatible metal implants
- Known allergy or intolerance to MRI contrast agent gadolinium
- Unable or unwilling to tolerate prolonged stationary position during treatment (2-3 hours)
- More than 30% of skull area in sonication path covered by scars, scalp disorders, or atrophy
- Implanted objects in skull or brain
- Advanced kidney disease or on dialysis
- Impaired renal function with eGFR less than 30 mL/min/1.73m2
- Unstable cardiac status or severe hypertension including recent myocardial infarction, unstable angina, worsening heart failure, low ejection fraction, unstable arrhythmias, pacemaker, or diastolic BP above 100 on medication
- History of abnormal bleeding, hemorrhage, or coagulopathy
- Receiving anticoagulant or antiplatelet therapy near treatment time or drugs increasing bleeding risk
- Abnormal coagulation lab values beyond normal limits
- Cerebrovascular disease grade II or III on Fazekas MRI scale
- Past or present schizophrenia, psychotic disorder, bipolar disorder, or untreated non-substance induced depression
- High depression scores or suicide risk
- History of suicide attempt or parental history of completed suicide
- Diagnosis of Cluster A or B Personality Disorders
- Dementia or significant cognitive impairment
- Brain tumors
- Severe chronic pulmonary disorders
- Known CNS infection or HIV infection; Hepatitis C allowed if liver function normal
- Prior deep brain stimulation or stereotactic ablation of NAc, basal ganglia or thalamus
- Botulinum toxin injections in arm, neck, or face within 5 months
- Currently in another clinical trial with active treatment
- Unwilling to abstain from illicit substance use during study
- Considered poor surgical or study candidate due to medical, social, or psychological issues
- Non-English speaking
- Pregnant or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Tampa General Hospital
Tampa, Florida, United States, 33606
Not Yet Recruiting
2
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
4
West Virginia University: Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
K
Kingsley Nwaogu
CONTACT
J
Julia Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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