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Behavioural Intervention

Ultrasound Therapy for Opioid Use Disorder

N/A
Recruiting
Research Sponsored by Ali Rezai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 22 - 60 years at time of enrollment
Be between 18 and 65 years old
Must not have
Subject with impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
Past or present diagnosis of schizophrenia or psychotic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-exablate procedure through 90 day follow-up
Awards & highlights

Summary

This trial is studying the use of a treatment called LIFU on the brain areas NAc and VC in people with severe opioid use disorder who have not responded to other treatments.

Who is the study for?
This trial is for adults aged 22-60 with severe opioid use disorder (OUD) that's lasted at least two years. Women who can have children must test negative for pregnancy and agree to use birth control. It's not suitable for those who don't meet these criteria.
What is being tested?
The study tests Low Intensity Focused Ultrasound (LIFU) on the brain areas NAc and VC, comparing it with a sham (fake treatment) in people whose OUD hasn't improved with standard treatments. Participants are chosen randomly to receive either LIFU or the sham.
What are the potential side effects?
Potential side effects of LIFU may include discomfort at the site of application, headache, or mood changes; however, specific side effects will be monitored given this is an investigational approach.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is low, with a filtration rate under 30 mL/min.
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I have been diagnosed with schizophrenia or a psychotic disorder.
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My MRI shows signs of a brain or nerve condition.
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I have a long-term lung condition.
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I cannot have an MRI due to implants or discomfort in confined spaces.
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I have a significant neurological condition.
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I have had a stroke or brain lesion in the specific area of my brain.
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Over 30% of my skull area has scars, scalp disorders, or thinning.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-exablate procedure through 90 day follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-exablate procedure through 90 day follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Opioid Use
Occurrence of Treatment Emergent Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LIFU TreatmentExperimental Treatment1 Intervention
Group II: Sham treatmentPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Ali RezaiLead Sponsor
4 Previous Clinical Trials
45 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,342 Total Patients Enrolled
~23 spots leftby Oct 2026
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