A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Abuse Disorders (SUDs)

InSightec7 sites in 1 country29 target enrollmentNovember 27, 2019

ConditionsOpioid-use Disorder Substance Use Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Opioid-use Disorder
Sponsor: InSightec
Enrollment: 29
Locations: 7
Primary Endpoint: Occurrence of Treatment Emergent Adverse Events
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.

Registry

clinicaltrials.gov

Start Date

November 27, 2019

End Date

December 31, 2027

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

InSightec

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and non-pregnant females, age 18 - 60 years old
•Subject meets DSM-5 criteria for OUD and/or other SUDs including alcohol (assessed via the SCID-5) of at least two years duration
•Subject is 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; residential or inpatient treatment from the WVU Center for Hope and Healing or an affiliated WVU hospital; or receiving outpatient/inpatient/residential treatment from similar programs that are well known to the research team. If the subject is prescribed medication for AUD or OUD (e.g. buprenorphine-naloxone, naltrexone), they will be on a stable dose of the medication for the 7 days prior to the procedure. Stable is defined as within the therapeutic range but does not require same exact dose for 7 days.
•Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen
•The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements)
•Subject is able to communicate sensations during the Exablate Transcranial procedure
•Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
•Subject is able to make own medical decisions as determined by the clinical team
•Subject has signed and received a copy of the approved informed consent form

Exclusion Criteria

•Subjects who are taking medications which may adversely interact with MOUD (See Appendix B for full list). Being on one of these medications would not automatically exclude a participant from study participation, does not automatically exclude a prospective subject from study participation. If a prospective or current subject is taking any medication listed in Appendix B, the study investigator is responsible for determining whether the subject is eligible for inclusion or continued study participation."
•Subject with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
•Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)
•Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
•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
•Subject with implanted objects in the skull or the brain
•Subject diagnosed with advanced kidney disease or on dialysis
•Subject with impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
•Subject with known unstable cardiac status or severe hypertension including:
•Documented myocardial infarction within six months of enrollment