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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
At a glance
Conditions
Where it's being run
4 sites across 4 statesWho to contact
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What this trial measures
- 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.