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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Exablate Model 4000 Type 2.0/2.1
DeviceThere are two treatment stages. In both stages, the subject will receive both the sham and active ExAblate treatment, and be evaluated for 90 days post-treatment for adverse events. During Stage 1 the subject will receive the moderate intensity Exablate LIFU procedure. During Stage2, the subject will receive the enhanced intensity ExAblate LIFU procedure. The subjects are blinded as to the order of the sham vs active treatment.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Sham/Active ExAblate Treatment Stage 1 and 2Other 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of Treatment Emergent Adverse Events
Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
Time frame
Post-ExAblate Procedure through 4 Month Follow-Up Source ClinicalTrials.gov