Who is eligible for clinical trial NCT04197921?

Participants must meet protocol criteria for Opioid-use Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04197921 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-24

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs) (NCT04197921)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: InSightec

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (37 items).

Location: Tampa General Hospital — Tampa, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check 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).

Males and non-pregnant females, age 18 - 60 years old
Subject meets DSM-5 criteria for OUD and/or other SUDs including alcohol (assessed via the SCID-5) of at least two years duration
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.
Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen
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)
Subject is able to communicate sensations during the Exablate Transcranial procedure
Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
Subject is able to make own medical decisions as determined by the clinical team
Subject has signed and received a copy of the approved informed consent form

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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."
Subject with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)
Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
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 implanted objects in the skull or the brain
Subject diagnosed with advanced kidney disease or on dialysis
Subject with impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
Subject with known unstable cardiac status or severe hypertension including:
Documented myocardial infarction within six months of enrollment
Unstable angina on medication

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

Tampa General Hospital — Tampa, Florida
University of Maryland, Baltimore — Baltimore, Maryland
Weill Cornell Medicine — New York, New York
West Virginia University: Rockefeller Neuroscience Institute — Morgantown, West Virginia

💰 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 § 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.

🏛️ View Official NIH Record ↗