Neuromodulation in Substance Use Disorders

Launched by ALI REZAI · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on exploring a treatment called FUS neuromodulation for people dealing with substance use disorders (SUDs), particularly opioid use disorder (OUD). The main goal of the study is to see if this treatment is safe and practical for participants aged 22 to 60 who have a history of substance use issues for at least two years. To be eligible, participants must currently be receiving treatment from specific outpatient programs and agree to communicate with their healthcare providers about their care during the study.

If you or someone you know is interested in participating, it's important to note that not everyone will qualify. For example, individuals with certain neurological conditions, significant brain abnormalities, or a history of severe mental health issues may not be eligible. Participants can expect to undergo assessments to ensure their safety and to see if this treatment could help them on their recovery journey. The trial is not yet recruiting, but it aims to offer new insights into how neuromodulation can support those facing challenges with substance use.

Gender

ALL

Eligibility 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