Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substan… (NCT04197921) | Clinical Trial Compass
RecruitingNot Applicable
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
United States29 participantsStarted 2019-11-27
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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
Exclusion criteria
✕
What they're measuring
1
Occurrence of Treatment Emergent Adverse Events
Timeframe: Post-ExAblate Procedure through 4 Month Follow-Up
. 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