Opioid Use DisorderNCT06297200
Low-Intensity Focused Ultrasound and the Complex Patient
A study testing Low-Intensity Focused Ultrasound in people with Opioid Use Disorder and Chronic Pain, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Chronic Pain, Anxiety Disorder
- What is being tested?
- Low-Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-65 years
- 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.
- 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.
- 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.
- Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
- 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.
Who cannot join
- Evidence of neuropathic pain
- Previous spine surgery
- Current substance use disorder other than OUD or tobacco use disorder
- Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
- Chronic Pain Conditions other than chronic back pain
- Daily opiate use other than buprenorphine/methadone for OUD/pain control
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- Pregnant or breastfeeding
- History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
- 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
- Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
- 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
- Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
Jessica Florig, MPH, 540-526-2261, jnw@vtc.vt.edu
Wynn Legon, PhD
About this study
Official title: Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
- Conditions
- Opioid Use Disorder, Chronic Pain, Anxiety Disorder
- Being tested
- Low-Intensity Focused Ultrasound, Low-Intensity Focused Ultrasound - sham
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Focused UltrasoundDevice
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.
Low-Intensity Focused Ultrasound - shamDevice
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
| Study group | Role | What they receive |
|---|---|---|
| Pain, Craving, and Anxiety measures | Experimental | Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention. Receives: Device: Low-Intensity Focused Ultrasound; Device: Low-Intensity Focused Ultrasound - sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events via a neurological examination
Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.
Measured: Assessed per participant, over the course of participation - an average of 4 weeks
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire
Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.
Measured: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Heart Rate (HR)
changes in HR compared pre/post LIFU and at follow up
Measured: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Respiration Rate (RR)
changes in RR compared pre/post LIFU and at follow up
Measured: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale.
changes in mood scale compared pre/post LIFU and at follow up
Measured: Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Blood Pressure (BP)
changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up
Measured: Assessed per participant, over the course of participation - an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start4 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Salem VA Medical Center, Washington DC VA Medical Center
- Responsible party
- Principal investigator, Wynn Legon, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297200
- Sponsor's protocol ID
- 24-050
- Status last verified
- Oct 2025
- First submitted
- 19 Feb 2024
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
- ClinicalTrials.gov ID
- NCT06297200
- Acronym / sponsor ID
- 24-050
- Conditions
- Opioid Use Disorder, Chronic Pain, Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Salem VA Medical Center, Washington DC VA Medical Center
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain, Craving, and Anxiety measures | Experimental | Device: Low-Intensity Focused Ultrasound, Device: Low-Intensity Focused Ultrasound - shamMulti visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females aged 18-65 years
- 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.
- 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.
- 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.
- Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
Key exclusion criteria (12 listed)
- Evidence of neuropathic pain
- Previous spine surgery
- Current substance use disorder other than OUD or tobacco use disorder
- Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
- Chronic Pain Conditions other than chronic back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Focused UltrasoundA 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. | Device | Pain, Craving, and Anxiety measures |
| Low-Intensity Focused Ultrasound - shamA sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain. | Device | Pain, Craving, and Anxiety measures |
Primary outcome
Incidence of Treatment-Emergent Adverse Events via a neurological examination
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Focused Ultrasound in people with Opioid Use Disorder and Chronic Pain, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Florig, MPH (540-526-2261, jnw@vtc.vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events via a neurological examination (time frame: Assessed per participant, over the course of participation - an average of 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.