No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
25 (estimated)
Sponsor
Washington D.C. Veterans Affairs Medical Center · Federal
Who this trial is looking for
This trial is looking for adults aged 18-75 with chronic back pain, anxiety, and opioid use disorder. Participants will receive low intensity focused ultrasound treatment, and their pain and anxiety will be assessed during the trial.
Are You a Good Fit for This Trial?
Must be takingBuprenorphineMethadone
Rules you outNeuropathic painSchizophreniaPregnancyUnstable heart conditions
You may be able to join if
I am between 18 and 75 years old.
I have chronic back pain that has lasted for at least three months.
I have been diagnosed with opioid use disorder.
I am currently receiving treatment for opioid use disorder.
I meet the criteria for an anxiety disorder.
I rate my pain intensity at 4 out of 10 or greater.
I have evidence of central sensitization based on specific scoring.
You may not be able to join if
I have evidence of neuropathic pain.
I have another substance use disorder other than opioid use disorder.
I have a diagnosis of schizophrenia or schizo-affective disorder.
I am pregnant or breastfeeding.
I use benzodiazepines or opiates daily outside of my treatment.
I have a history of seizures or significant neurological disorders.
I have unstable medical conditions like heart failure or active infections.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 disorde…
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.
Trial Locations
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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 meas…
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.
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