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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Low Intensity Focused Ultrasound (LIFU) using the Exablate device to assist individuals with Opioid Use Disorder (OUD). The goal is to determine if this treatment is safe and tolerable for those who have struggled with OUD for at least two years and are currently in a treatment program. Suitable candidates are those who have abstained from opioids and other drugs (except cannabis) and are participating in outpatient or inpatient treatment. Participants will undergo two treatment stages, one of which is a sham (fake) treatment, without knowing which is which. The study aims to find better ways to support recovery from OUD. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could lead to innovative recovery solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medication for opioid or alcohol use disorder, you must be on a stable dose for 7 days before the procedure. If you are taking medications that might interact with the study treatment, the study investigator will decide if you can participate.

What prior data suggests that the Exablate device is safe for neuromodulation in opioid use disorder?

Research has shown that the Exablate system, which uses Low Intensity Focused Ultrasound (LIFU), is generally safe for humans. In past studies, this device temporarily opened the blood-brain barrier without major problems. Reported side effects align with known risks, and no new safety concerns have emerged. Although primarily used for conditions like essential tremors, the absence of new risks suggests it is well-tolerated. However, since this information comes from its use in other conditions, monitoring during this trial will help confirm its safety for people with Opioid Use Disorder (OUD). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Exablate for opioid use disorder because it uses Low-Intensity Focused Ultrasound (LIFU) neuromodulation, a novel approach different from traditional treatments like medication-assisted therapies (e.g., methadone, buprenorphine) and behavioral interventions. Unlike these standard treatments that primarily target neurotransmitter systems chemically, Exablate aims to modulate brain activity non-invasively by using focused ultrasound waves. This technique offers the potential to precisely target specific brain regions involved in addiction without the need for surgery or drugs, which could lead to fewer side effects and improved patient outcomes.

What evidence suggests that the Exablate device is effective for Opioid Use Disorder?

Research has shown that Low Intensity Focused Ultrasound (LIFU) using the Exablate system might alter nerve activity. This trial is studying the technique for opioid use disorder (OUD). Participants will receive both sham and active Exablate treatments, with the treatment order blinded. Other research has found the Exablate system effective in reducing symptoms of essential tremor, a movement disorder. While specific results for OUD are still being collected, LIFU is believed to target brain areas linked to addiction. This method is being explored as a potential way to manage OUD by reducing cravings and withdrawal symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Ali Rezai

Principal Investigator

WVU Rockefeller Neuroscience Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04197921

Exablate for LIFU Neuromodulation in Patients With Opioid ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06474026

Study Details | NCT06474026 | A Clinical Trial to Evaluate ... This clinical trial aims to evaluate the safety and efficacy of neuromodulation using 'ExAblate 4000 Type 2.1' in patients with psychostimulant use disorder ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The ExAblate Neuro is intended for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory ...

4. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDE2MzI0N1PS0bWEARxMcz0jU0MLAwszHUNzE2MTM1MzAxDQUcpLLjEwM7IwNDc1U4oFAOuwFNM-

Save Selected This study will use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating ...

5. fdaaa.trialstracker.net fdaaa.trialstracker.net/

Who's sharing their clinical trial results? NCT03322813, A Study to Evaluate the Safety and Feasibility of Exablate Model 4000 Type-2 ... Opioid Use in Pediatric Patients in the Post-Operative Period ...

6. ctv.veeva.com ctv.veeva.com/study/exablate-for-lifu-neuromodulation-in-patients-with-opioid-use-disorder-oud

Exablate for LIFU Neuromodulation in Patients With Opioid ... 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03551249

Study Details | NCT03551249 | Assessment of Safety and ... The ExAblate Model 4000 Type 2 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with ...

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=15379038&pc=POH

MAUDE Adverse Event Report: INSIGHTEC LTD. EXABLATE ... This complaint includes known side effects for essential tremor treatment.No new risks were identified.No device malfunction was detected.

9. dana-farber.org dana-farber.org/clinical-trials/20-489

Assessment of Safety and Feasibility of Exablate Type 2 for ... The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain- ...