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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04197921
Recruitment Status : Active, not recruiting
First Posted : December 13, 2019
Last Update Posted : December 1, 2021
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Device: Exablate Model 4000 Type 2.0/2.1 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD)
Actual Study Start Date : November 27, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Sham/Active ExAblate Treatment Stage 1 and 2
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
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.

Primary Outcome Measures :
  1. Occurrence of Treatment Emergent Adverse Events [ Time Frame: Post-ExAblate Procedure through 4 Month Follow-Up ]
    Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Right-handed males and right-handed non-pregnant females, age 18 - 60 years old
  2. Subject is current participant in the WVU Comprehensive Opioid Addiction Treatment Program, has advanced to the second level of the program (90 days sustained abstinence) and on a stable dose of suboxone/naltrexone for the last 90 days
  3. Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen
  4. Subject is able to communicate sensations during the Exablate Transcranial procedure
  5. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
  6. Subject is able to make own medical decisions as determined by the clinical team
  7. Subject has signed and received a copy of the approved informed consent form

Exclusion Criteria:

  1. Subjects who are taking prohibited medications which may adversely interact with suboxone or naltrexone (See Appendix B for full list)
  2. Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)
  3. Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
  4. Subject with implanted objects in the skull or the brain
  5. Subject with impaired renal function
  6. Subject with known unstable cardiac status or severe hypertension
  7. Subject with history of abnormal bleeding, hemorrhage, or coagulopathy
  8. Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression
  9. History of suicide attempt
  10. Parental history of completed suicide
  11. Diagnosis of dementia
  12. Subject with brain tumors
  13. Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis
  14. Any known CNS infection or infection with the Human Immunodeficiency Virus (HIV) or Hepatitis C
  15. Subject who is currently participating in another clinical investigation with an active treatment arm
  16. Subject unwilling to abstain from illicit substance use during the course of the study
  17. Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator
  18. Subject is non-English speaking
  19. Subject is pregnant or planning to be pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04197921

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United States, Virginia
West Virginia University: Rockefeller Neuroscience Institute
Morgantown, Virginia, United States, 26506
Sponsors and Collaborators
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Responsible Party: InSightec Identifier: NCT04197921    
Other Study ID Numbers: OUD001
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders