LIFU Neuromodulation for Opioid Use Disorder

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Must be taking: Buprenorphine-naloxone, Naltrexone

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Schizophrenia, Bipolar, Severe hypertension, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

5 Participants Needed

Trial Summary

What is the purpose of 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) by assessing its safety and tolerability in subjects with OUD.

Research Team

Ali Rezai

Principal Investigator

WVU Rockefeller Neuroscience Institute

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder (OUD) who are seeking additional treatment options. Specific eligibility criteria details were not provided, so interested participants should contact the study organizers for more information.

Inclusion Criteria

I am capable of making my own medical decisions.

Subject is able to communicate sensations during the Exablate Transcranial procedure

Subject meets DSM-5 criteria for OUD and/or other SUDs including alcohol (assessed via the SCID-5) of at least two years duration

Exclusion Criteria

Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)

Subject with implanted objects in the skull or the brain

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo both sham and active ExAblate treatments with enhanced intensity

4 weeks

Multiple visits for treatment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Regular follow-up visits

Treatment Details

Interventions

• Exablate

Trial Overview The trial is testing a technique called Low Intensity Focused Ultrasound (LIFU) using Exablate Model 4000 Type 2.0/2.1 to see if it can help people with OUD as an extra form of treatment by checking its safety and how well patients can tolerate it.

Participant Groups

Group I: Sham/Active ExAblate Treatment Stage 1 and 2 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

InSightec

Industry Sponsor

Trials

92

Recruited

3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+