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A Feasibility Clinical Trial for Low Intensity Focused Ultrasound Neuromodulation in Patients with Opioid Use Disorder (OUD) and/or other Substance Use Disorders (SUD)

Clinical Trial Details

This study aims to examine the safety and usefulness of low-intensity focused ultrasound (LIFU) in treating people with Opioid Use Disorder (OUD) and/or other substance use disorders (SUDs).

This study uses the Exablate Model 4000 System, a noninvasive magnetic resonance imaging (MRI) guided focus ultrasound. This device consists of approximately 1009 ultrasound probes that activate simultaneously at low frequency. When activated, the device will administer low-intensity focused ultrasound energy to the brain, changing its activity in a process called neuromodulation. In this study, the device will target a specific brain area, the nucleus accumbens, involved in motivation, reward, and aversion.

The use of this device to treat OUD and/or SUD is investigational and has not been approved by the U.S. Food and Drug Administration (FDA).

We hope to learn if the desire to use opioids or other substances changes, and if the function of the brain and how participants think and behave changes with this study procedure. 

Total study participation will last one year after the initial procedure and will consist of multiple study visits during that time. 

Key Eligibility: 

   1. Open to males and non-pregnant females, aged 18 – 60 years old
   2. Participant meets DSM-5 criteria for OUD and/or other SUDs, including alcohol (assessed via the SCID-5) of at least two years duration
   3. Participant is currently receiving SUD behavioral treatment (e.g. outpatient or residential; individual and/or group)

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Anna Angkatavanich
203-962-5068
ana4037@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2408027793

ClinicalTrials.gov:

NCT04197921

Sponsor:

OUD001

Status

Not Yet Recruiting

Age Group

Adult

Sponsor