Who is eligible for clinical trial NCT07010016?

Participants must meet protocol criteria for Substance Use Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07010016 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-10-15

Neuromodulation in Substance Use Disorders (NCT07010016)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Manish Ranjan

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (14 items).

Location: WVU Rockefeller Neuroscience Institute — Morgantown, West Virginia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

WVU Rockefeller Neuroscience Institute — Morgantown, West Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗