Suspended

Focused Ultrasound Neuromodulation for Substance Use Disorders

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

NaviFus Model101

Device
Who is being recruted

Mental Disorders

+ Substance-Related Disorders

+ Chemically-Induced Disorders

From 22 to 60 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorManish Ranjan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 7, 2025

Actual date on which the first participant was enrolled.

This study explores a new technique called Focused Ultrasound (FUS) to help people who have problems with opioid use or other substances. It targets a specific part of the brain known as the NAc/VC, which may be involved in craving and substance use behaviors. The study aims to see if this method can reduce the craving for drugs in these individuals. This research is important because it could lead to new ways to treat substance use disorders, which are challenging to manage with current methods. Participants in the study will first go through a screening process to ensure they are suitable for the treatment. Once eligible, they will receive the FUS treatment targeting both sides of the NAc/VC area of the brain. During the study, there will be assessments to measure their behavior and cravings before, during, and after the treatment. Follow-up visits are scheduled for Day 1, and at Weeks 1, 4, 8, and 12 to monitor changes and gather data on the treatment's effects. The study does not specify particular benefits or risks, but it aims to provide insight into the potential of FUS as a treatment for substance use disorders.

Official TitleEarly Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Opioid Use Disorder and/or Other Substance Use Disorders
NCT07010016
Principal SponsorManish Ranjan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersChemically-Induced Disorders

Criteria

6 inclusion criteria required to participate
Aged 22 - 60 years at time of enrollment.
Fulfill current DSM-5 diagnostic criteria for OUD and/or other SUDs with at least a 2-year history.
Currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction
Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; or receiving outpatient/inpatient/residential treatment from similar SUD treatment programs.
Show More Criteria
13 exclusion criteria prevent from participating
Unable to undergo MR-imaging because of non-MR compatible implants or if candidates are uncomfortable in small spaces (have claustrophobia).
History of any clinically significant neurological disorder.
History of stroke or brain lesion with observable structural abnormalities in the targeted brain region.
Clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Participants will undergo FUS in the bilateral NAc/VC

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

WVU Rockefeller Neuroscience Institute

Morgantown, United StatesOpen WVU Rockefeller Neuroscience Institute in Google Maps
SuspendedOne Study Center