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

InSightec
NCT IDNCT04197921ClinicalTrials.gov data as of Apr 2026
Target enrollment

29

Study length

about 7.1 years

Ages

18–60

Locations

4 sites in FL, MD, NY +1

What this study is about

This trial is testing a device called Exablate Model 4000 Type 2.0/2.1, used with Low Intensity Focused Ultrasound (LIFU), as an additional treatment for Opioid Use Disorder (OUD) and other substance use disorders. The goal is to see if this device is safe and well-tolerated in people with OUD.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Use Exablate Model 4000 Type 2.0/2.1

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Occurrence of Treatment Emergent Adverse Events

Body systems

Psychiatry / Mental Health