Focused Ultrasound for Opioid Use Disorder, Chronic Back Pain, and Anxiety

This study is looking at a treatment called low-intensity focused ultrasound (LIFU) for people who have opioid use disorder, chronic back pain, and anxiety. LIFU uses sound waves to gently change brain activity in a specific area called the anterior insula (AI), which is thought to play a role in pain, addiction, and anxiety. The main goals are to see if LIFU is safe and well-tolerated, and if it can help reduce pain, anxiety, and cravings for opioids. You might be able to join if you are 18-75 years old, have chronic back pain for at least three months, and show signs of central sensitization (a condition where your nervous system becomes over-sensitive to pain). The study plans to enroll 25 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will compare LIFU to a sham (inactive) treatment in 25 participants.
What's involved
Participants will have an MRI scan, neurological assessments, and clinical assessments. They will receive one session of LIFU or sham treatment.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured immediately before and within one hour after the LIFU or sham session.

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NCT06453109

Focused Ultrasound for the Complex Patient

Recruiting
NAAges 18–75InterventionalBasic science
Washington D.C. Veterans Affairs Medical Center
~25 participants
Updated 2024-11-20 on ClinicalTrials.gov
What's tested:low intensity focused ultrasound (LIFU)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over 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
Opioid Use Disorder
Chronic Back Pain
Anxiety
1 sites across 1 states
District of Columbia1
  • Mary R Lee, MD · PRINCIPAL_INVESTIGATOR · Washington D.C. Veterans Affairs Medical Center

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  • Incidence of Treatment-Emergent Adverse Eventsimmediately 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

    number of adverse events