RecruitingOpioid-use DisorderSubstance Use Disorders
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
Eligible age
18–60 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: InSightec
You may qualify if…
- ✓ 1. Males and non-pregnant females, age 18 - 60 years old
- ✓ 2. Subject meets DSM-5 criteria for OUD and/or other SUDs including alcohol (assessed via the SCID-5) of at least two years duration
- ✓ 3. Subject is currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; residential or inpatient treatment from the WVU Center for Hope and Healing or an affiliated WVU hospital; or receiving outpatient/inpatient/residential treatment from similar programs that are well known to the research team. If the subject is prescribed medication for AUD or OUD (e.g. buprenorphine-naloxone, naltrexone), they will be on a stable dose of the medication for the 7 days prior to the procedure. Stable is defined as within the therapeutic range but does not require same exact dose for 7 days.
- ✓ 4. Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen
- ✓ 5. The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements)
- ✓ 6. Subject is able to communicate sensations during the Exablate Transcranial procedure
- ✓ 7. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
- ✓ 8. Subject is able to make own medical decisions as determined by the clinical team
You may not qualify if…
- ✕ 1. Subjects who are taking medications which may adversely interact with MOUD (See Appendix B for full list). Being on one of these medications would not automatically exclude a participant from study participation, does not automatically exclude a prospective subject from study participation. If a prospective or current subject is taking any medication listed in Appendix B, the study investigator is responsible for determining whether the subject is eligible for inclusion or continued study participation."
- ✕ 2. Subject with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
- ✕ 3. Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)
- ✕ 4. Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
- ✕ 5. 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
- ✕ 6. Subject with implanted objects in the skull or the brain
- ✕ 7. Subject diagnosed with advanced kidney disease or on dialysis
- ✕ 8. Subject with impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
Where it's recruiting
Source: ClinicalTrials.gov · NCT04197921 · last updated 2026-06-26