Substance Use Disorder
Conditions
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.
Interventions
DEVICENaviFus Model101
FUS Neuromodulation
Sponsors
Manish Ranjan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed