Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInSightec
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Exablate Model 4000 Type 2.0/2.1
Treatment groups
29 Participants
are divided into 1 treatment groupLocations
4Tampa General Hospital33606, TampaFlorida, United States
University of Maryland, Baltimore21201, BaltimoreMaryland, United States
Weill Cornell Medicine10065, New YorkNew York, United States
West Virginia University: Rockefeller Neuroscience Institute26505, MorgantownWest Virginia, United States
Sponsors and collaborators
InSightec
Lead sponsor
Source ClinicalTrials.gov