NCT04197921

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

A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Abuse Disorders (SUDs)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Opioid-use Disorder
• Substance Use Disorders

Interventions

Type	Name	Description
DEVICE	Exablate Model 4000 Type 2.0/2.1	There are two treatment stages. In both stages, the subject will receive both the sham and active ExAblate treatment, and be evaluated for 90 days post-treatment for adverse events. During Stage 1 the subject will receive the moderate intensity Exablate LIFU procedure. During Stage2, the subject will receive the enhanced intensity ExAblate LIFU procedure. The subjects are blinded as to the order of the sham vs active treatment.

Timeline

• Start date: 2019-11-27
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2019-12-13
• Last updated: 2026-03-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study