Exablate for Opioid and Substance Use Disorders

This study is looking at a device called Exablate® Model 4000 Type 2.0/2.1, which uses Low Intensity Focused Ultrasound (LIFU) to help treat Opioid Use Disorder (OUD) and other Substance Use Disorders (SUDs). The main goal is to see if this treatment is safe and well-tolerated. You might be able to join if you are 18-60 years old, have OUD or another SUD for at least two years, and are currently receiving outpatient treatment from specific programs like the WVU Comprehensive Opioid Addiction Treatment Program (COAT). The study plans to enroll 29 participants. The success of the study will be measured by tracking any side effects that happen after the Exablate procedure for up to four months.

Study design
This is an interventional study with a planned enrollment of 29 participants. You will receive both a sham (inactive) and active Exablate treatment.
What's involved
You will receive both a sham and active Exablate treatment and be evaluated for 90 days after treatment for side effects.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events for up to four months after the Exablate procedure.

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NCT04197921

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

Recruiting
NAAges 18–60InterventionalTreatment
InSightec
~29 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Exablate Model 4000 Type 2.0/2.1

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Treatment Emergent Adverse Events
Measured over Post-ExAblate Procedure through 4 Month Follow-Up
Opioid-use Disorder
Substance Use Disorders
4 sites across 4 states
Florida1
Maryland1
New York1
West Virginia1

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  • Occurrence of Treatment Emergent Adverse EventsPost-ExAblate Procedure through 4 Month Follow-Up

    Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.