← Back to Search

LIFU Neuromodulation for Opioid Use Disorder

N/A

Recruiting

Research Sponsored by InSightec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Right-handed males and right-handed non-pregnant females, age 18 - 60 years old

Be between 18 and 65 years old

Must not have

Subject with impaired renal function

Subject with known unstable cardiac status or severe hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-exablate procedure through 4 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether a device that uses low intensity focused ultrasound (LIFU) is safe and tolerable for treating opioid use disorder (OUD).

Who is the study for?

This trial is for right-handed males and females aged 18-60 with Opioid Use Disorder who are part of the WVU Comprehensive Opioid Addiction Treatment Program, have been abstinent for 90 days, and on stable medication. Excluded are those with severe health issues, other clinical trials participation, non-English speakers, pregnancy or planning to be pregnant, certain medication use, inability to stay still for treatment duration, bleeding disorders or mental health conditions.

What is being tested?

The study tests Low Intensity Focused Ultrasound (LIFU) using the Exablate Model 4000 Type 2.0/2.1 as an additional treatment method for OUD by evaluating its safety and how well subjects can tolerate it.

What are the potential side effects?

Potential side effects aren't specified but generally could include discomfort at the site of ultrasound application, headache from prolonged stationary position during treatment or reactions related to MRI contrast agents used in procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a right-handed person aged between 18 and 60, and if female, not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is not normal.

Select...

I have severe high blood pressure or unstable heart conditions.

Select...

I do not have any CNS infections, HIV, or Hepatitis C.

Select...

I am not on any medications that would interfere with suboxone or naltrexone.

Select...

I have a history of abnormal bleeding or blood clotting issues.

Select...

I have been diagnosed with dementia.

Select...

I have a severe lung condition like emphysema.

Select...

I have a brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-exablate procedure through 4 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-exablate procedure through 4 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-exablate procedure through 4 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of Treatment Emergent Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sham/Active ExAblate Treatment Stage 1 and 2Experimental Treatment1 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.

0 / 9Eligibility criteria met