Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD)

NCT06612788 | Completed DMC FDA Device

• 2 other identifiers: OUD001UH3DA047714-04S1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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) by assessing its safety and tolerability in subjects with OUD.

Conditions

Opioid Use Disorder

Keywords

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Opioid-Related Disorders; Substance-Related Disorders

Outcome Measures

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.

  Post-ExAblate Procedure (Day 0) through 4 Month Follow-Up

Study Arms (1)

Sham/Active ExAblate Treatment Stage 1 and 2

OTHER

Subject will undergo both Treatment 1 (sham) and Treatment 2 (with enhanced intensity). Subjects are blinded to the order of the sham vs active treatment.

Device: Exablate Model 4000 Type 2.0/2.1

Interventions

Exablate Model 4000 Type 2.0/2.1 DEVICE

There 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.

Sham/Active ExAblate Treatment Stage 1 and 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 Unstable angina on medication Unstable or worsening congestive heart failure Left ventricular ejection fraction below the lower limit of normal History of a hemodynamically unstable cardiac arrhythmia Cardiac pacemaker Severe hypertension (diastolic BP \> 100 on medication)
• Subject with history of abnormal bleeding, hemorrhage, or coagulopathy
• Subject receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
• Abnormal coagulation profile (PLT \< 100,000/μl), PT (\>13.9 sec) or PTT (\>37.5 sec), and INR \> 1.2. If values are outside the range of normal limits, any clinically significant value may be excluded as determined by a study investigator.
• Subject with cerebrovascular disease as determined by MRI according to the Fazekas criteria. Grades II and III on the Fazekas scale should be excluded
• Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5)
• Score of greater than 17 on the Hamilton Depression Rating Scale (HAM-D) or increased risk of suicide based on any positive response regarding passive or active suicidal ideation with or without intent over the past 3 months or lifetime history of active suicidal ideation with intent on the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline

Sponsors & Collaborators

• West Virginia University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• InSightec: collaborator

Study Sites (1)

West Virginia University: Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Substance-Related Disorders

Study Officials

• Ali Rezai, MD

  WVU Rockefeller Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 25, 2024
• Study Start: September 19, 2023
• Primary Completion: July 8, 2024
• Study Completion: April 25, 2025
• Last Updated: July 20, 2025

Record last verified: 2024-09

Locations

US (1)