NCT06453109 Focused Ultrasound for the Complex Patient
| NCT ID | NCT06453109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington D.C. Veterans Affairs Medical Center |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-04-29 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\[s\] it aims to answer are: * the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain * the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.
Eligibility Criteria
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.
Contact & Investigator
Mary R Lee, MD
PRINCIPAL INVESTIGATOR
Washington D.C. Veterans Affairs Medical Center
Frequently Asked Questions
Who can join the NCT06453109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06453109 currently recruiting?
Yes, NCT06453109 is actively recruiting participants. Contact the research team at mary.lee3@va.gov for enrollment information.
Where is the NCT06453109 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06453109 clinical trial?
NCT06453109 is sponsored by Washington D.C. Veterans Affairs Medical Center. The principal investigator is Mary R Lee, MD at Washington D.C. Veterans Affairs Medical Center. The trial plans to enroll 25 participants.