Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) (NCT06612788) | Clinical Trial Compass
CompletedNot Applicable
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD)
United States5 participantsStarted 2023-09-19
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) 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 dete…
What they're measuring
1
Occurrence of Treatment Emergent Adverse Events
Timeframe: Post-ExAblate Procedure (Day 0) through 4 Month Follow-Up