NCT06297200 Low-Intensity Focused Ultrasound and the Complex Patient
| NCT ID | NCT06297200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Polytechnic Institute and State University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2026-10 |
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 2024-12-04 with a primary completion date of 2026-10.
⚠ 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
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Eligibility Criteria
Inclusion Criteria: 1. Males and females aged 18-65 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. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5. 5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone. 6. 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 DSM-5. Exclusion Criteria: 1. Evidence of neuropathic pain 2. Previous spine surgery 3. Current substance use disorder other than OUD or tobacco use disorder 4. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder 5. Chronic Pain Conditions other than chronic back pain 6. Daily opiate use other than buprenorphine/methadone for OUD/pain control 7. Pregnant or breastfeeding 8. History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases 9. 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 10. Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI) 11. Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist 12. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06297200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 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 NCT06297200 currently recruiting?
Yes, NCT06297200 is actively recruiting participants. Contact the research team at jnw@vtc.vt.edu for enrollment information.
Where is the NCT06297200 trial being conducted?
This trial is being conducted at Roanoke, United States.
Who is sponsoring the NCT06297200 clinical trial?
NCT06297200 is sponsored by Virginia Polytechnic Institute and State University. The trial plans to enroll 25 participants.