Neuromodulation in Substance Use Disorders

Not Applicable

Not yet recruiting

• Conditions: Substance Use Disorder

• Registration Number: NCT07010016
• Lead Sponsor: Ali Rezai

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.

Detailed Description

This is an open-label early feasibility study investigating low intensity FUS targeting the NAc/VC for participants with OUD and/or other SUDs. Once participants are deemed eligible following Screening/Baseline, participants will undergo FUS in the bilateral NAc/VC with Behavioral and Substance Craving assessments performed prior to, during, and following the treatment. Participants will be assessed during follow-up visits on Day 1, Week 1, 4, 8, and 12.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Study Start: 2025-07
• Primary Completion: 2027-07-30
• Study Completion: 2028-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurrence of Treatment Emergent Adverse Events	Beginning Day 0 (the day of the FUS procedure) through Week 4	Incidence of Investigational procedure and device-related adverse Incidence of Investigational procedure and device-related adverse events and SAEs