Using focused ultrasound to treat pain, anxiety, and opioid cravings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to inhibit the anterior insula (AI) using low-intensity focused ultrasound (LIFU) to explore its role in pain processing, anxiety, and opioid cravings in individuals with opioid use disorder, chronic back pain, and anxiety disorders. Participants will receive either LIFU or sham stimulation, and their safety and tolerability will be assessed through MRI, neurological assessments, and clinical evaluations. The study seeks to determine the effects of LIFU on pain, anxiety symptoms, and cravings, potentially offering a new non-invasive treatment approach for this complex patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males and females aged 18-75 years
2. Current diagnosis of Chronic Back Pain as defined by 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.
3. Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.
4. Participants must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPI-SF)
5. Meet the DSM-5 criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
6. Be in treatment for OUD including buprenorphine or methadone.
7. Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5).

Exclusion Criteria:

1. Evidence of neuropathic pain
2. Current DSM-5 substance use disorder other than OUD, tobacco use disorder
3. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
4. Pregnant or breastfeeding
5. Daily use of benzodiazepines or opiates (other than buprenorphine or methadone)
6. History of seizures, neurologic disorders, including cerebrovascular disease, history of stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases. They will not have history of metastasizing cancers, inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis, unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome.
7. Ferromagnetic implants or other contraindications for MRI
8. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active systemic infection end stage renal disease.

Where it's running

• Washington DC Veterans Affairs Medical Center
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Mary R Lee, MD — Washington D.C. Veterans Affairs Medical Center
• Study coordinator: Mary R Lee, MD
• Email: mary.lee3@va.gov
• Phone: 202-745-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.