Focused Ultrasound Neuromodulation for Substance Use Disorders
NaviFus Model101
Mental Disorders
+ Substance-Related Disorders
+ Chemically-Induced Disorders
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Inclusion Criteria: * 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. * Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers. * Agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event. Exclusion Criteria: * 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. * An abnormal screening result that is considered clinically significant by a medically qualified research team member (i.e., laboratory tests, imaging findings). * More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. * Past or present diagnosis of schizophrenia or psychotic disorder (assessed via SCID- * History of medically verified suicide attempt within the past year. * Meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD). * Current substance use treatment mandated by court of law. * Subject who is currently participating in another clinical investigation with an active * treatment arm. * Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
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