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Procedure

Focused Ultrasound for Opioid Use Disorder (LIFU Trial)

N/A
Recruiting
Led By Mary R Lee, MD
Research Sponsored by Washington D.C. Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current diagnosis of Chronic Back Pain with pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months
Be in treatment for OUD including buprenorphine or methadone
Must not have
Evidence of neuropathic pain
Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately prior to 1 session low-intensity focused ultrasound (lifu) and within 1 hour post lifu; immediately prior to 1 session sham and with in 1 hour post sham
Awards & highlights

Summary

This trial aims to use low intensity focused ultrasound to block a specific part of the brain to see how it affects pain, anxiety, and cravings in people with opioid use disorder, anxiety, and chronic back

Who is the study for?
This trial is for individuals with chronic back pain, anxiety, and opioid use disorder. Participants must undergo MRI and neurological assessments to ensure safety. Details on specific inclusion or exclusion criteria are not provided.
What is being tested?
The study tests if low intensity focused ultrasound (LIFU) can safely target the anterior insula to affect pain, anxiety, and opioid cravings compared to a sham (fake) treatment.
What are the potential side effects?
Potential side effects are not detailed but will be monitored through clinical assessments and patient feedback regarding the tolerability of LIFU versus sham stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had chronic back pain for at least 3 months, with pain on most days in the last 6 months.
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I am currently receiving treatment for opioid use disorder with buprenorphine or methadone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience nerve pain.
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I have been diagnosed with schizophrenia or schizo-affective disorder.
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I have a history of seizures or neurological disorders.
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I have had cancer spread, significant weight loss, inflammation disorders, or cauda equina syndrome.
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I use benzodiazepines or opiates daily, but not buprenorphine or methadone.
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I do not have any unstable health conditions like heart failure or severe infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately prior to 1 session low-intensity focused ultrasound (lifu) and within 1 hour post lifu; immediately prior to 1 session sham and with in 1 hour post sham
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to 1 session low-intensity focused ultrasound (lifu) and within 1 hour post lifu; immediately prior to 1 session sham and with in 1 hour post sham for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Heart rate variability
Pain threshold

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham/LIFUExperimental Treatment1 Intervention
double-blind, sham-controlled, crossover study in N=25 individuals with opiate use disorder, anxiety, and chronic back pain
Group II: LIFU/ShamExperimental Treatment1 Intervention
double-blind, sham-controlled, crossover study in N=25 individuals with opiate use disorder, anxiety, and chronic back pain

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,488 Total Patients Enrolled
Washington D.C. Veterans Affairs Medical CenterLead Sponsor
41 Previous Clinical Trials
17,793 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,351 Total Patients Enrolled
~15 spots leftby Sep 2025
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