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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
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 belowSelect...
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.
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I have a history of abnormal bleeding or blood clotting issues.
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I have been diagnosed with dementia.
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I have a severe lung condition like emphysema.
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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
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
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.
Find a Location
Who is running the clinical trial?
InSightecLead Sponsor
90 Previous Clinical Trials
3,774 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have objects implanted in your skull or brain.I am willing to follow the study's requirements and attend all visits.You are able to talk about how you feel during the Exablate Transcranial procedure.My kidney function is not normal.I have severe high blood pressure or unstable heart conditions.I do not have any CNS infections, HIV, or Hepatitis C.You are not willing to stop using illegal drugs while participating in the study.I am a right-handed person aged between 18 and 60, and if female, not pregnant.I am not on any medications that would interfere with suboxone or naltrexone.I have a history of abnormal bleeding or blood clotting issues.I have been diagnosed with dementia.One or both of your parents have died by suicide.I am capable of making my own medical decisions.I am in the WVU opioid treatment program, past 90 days clean, and stable on medication.I have a severe lung condition like emphysema.You have been diagnosed with schizophrenia, psychotic disorder, bipolar disorder, or untreated depression in the past or currently.You have a known allergy or intolerance to the MRI contrast agent gadolinium (GADOVIST®).You have previously tried to harm yourself on purpose.I have a brain tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Sham/Active ExAblate Treatment Stage 1 and 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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