Suspended

Focused Ultrasound Neuromodulation for Substance Use Disorders

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What is being tested

NaviFus Model101

Device
Who is being recruted

Substance Use Disorder

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: October 20, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 7, 2025Actual 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 
Principal SponsorManish Ranjan
Last updated: October 20, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 22 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Substance Use Disorder
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

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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

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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

Incidence of Investigational procedure and device-related adverse Incidence of Investigational procedure and device-related adverse events and SAEs

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 InstituteMorgantown, United StatesSee the location
SuspendedOne Study Center