Neuromodulation in Substance Use Disorders

Manish Ranjan

Status

Active, not recruiting

Conditions

Substance Use Disorder

Treatments

Device: NaviFus Model101

Study type

Interventional

Funder types

Other

Identifiers

NCT07010016

RNI_NMD_SUD

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

22 to 60 years old

Volunteers

No Healthy Volunteers

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