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

NARecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

November 27, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Opioid-use DisorderSubstance Use Disorders
Interventions
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.

Trial Locations (4)

10065

RECRUITING

Weill Cornell Medicine, New York

21201

RECRUITING

University of Maryland, Baltimore, Baltimore

26505

ACTIVE_NOT_RECRUITING

West Virginia University: Rockefeller Neuroscience Institute, Morgantown

33606

NOT_YET_RECRUITING

Tampa General Hospital, Tampa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

InSightec

INDUSTRY

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