Neuromodulation in Substance Use Disorders

NCT07010016 | Active Not Recruiting DMC FDA Device

• 1 other identifier: RNI_NMD_SUD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.

Conditions

Substance Use Disorder

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment Emergent Adverse Events

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

  Beginning Day 0 (the day of the FUS procedure) through Week 4

Study Arms (1)

LIFU Neuromodulation

OTHER

Participants will undergo FUS in the bilateral NAc/VC

Device: NaviFus Model101

Interventions

NaviFus Model101 DEVICE

FUS Neuromodulation

LIFU Neuromodulation

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Manish Ranjan: lead

Study Sites (1)

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst Prof RNI

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 8, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)