Opioid Use Disorder, Chronic Pain, Anxiety Disorder
Conditions
Brief summary
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Interventions
A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Sponsors
Salem VA Medical Center
Washington DC VA Medical Center
Virginia Polytechnic Institute and State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events via a neurological examination | Assessed per participant, over the course of participation - an average of 4 weeks | Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data. |
| Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire | Assessed per participant, over the course of participation - an average of 4 weeks | Side effects and reported severity will be tabulated and summarized on a 5 point likert scale. |
| Changes in Heart Rate (HR) | Assessed per participant, over the course of participation - an average of 4 weeks | changes in HR compared pre/post LIFU and at follow up |
| Changes in Respiration Rate (RR) | Assessed per participant, over the course of participation - an average of 4 weeks | changes in RR compared pre/post LIFU and at follow up |
| Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale. | Assessed per participant, over the course of participation - an average of 4 weeks | changes in mood scale compared pre/post LIFU and at follow up |
| Changes in Blood Pressure (BP) | Assessed per participant, over the course of participation - an average of 4 weeks | changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up |
Countries
United States
Contacts
Primary ContactJessica Florig, MPH
Outcome results
None listed