RECRUITING

Focused Ultrasound for the Complex Patient

Conditions

Opioid Use Disorder Chronic Back Pain Anxiety anxiety disorders oud opiate use disorder opioid back pain opioid use opioid abuse opioid disorder low intensity focused ultrasound transcranial ultrasound

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Towards Treatment of the Complex Patient: Investigations of Low-intensity Focused Ultrasound

Quick Facts

Study Start:2024-04-29

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06453109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Mary R Lee, MD

CONTACT

202-745-8000

mary.lee3@va.gov

Krystian Burum, MS

CONTACT

krystian.burum@va.gov

Principal Investigator

Mary R Lee, MD

PRINCIPAL_INVESTIGATOR

Washington D.C. Veterans Affairs Medical Center

Study Locations (Sites)

Washington DC Veterans Affairs Medical Center

Washington, District of Columbia, 20422

United States

Collaborators and Investigators

Sponsor: Washington D.C. Veterans Affairs Medical Center

Mary R Lee, MD, PRINCIPAL_INVESTIGATOR, Washington D.C. Veterans Affairs Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-04-29

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

anxiety disorders
oud
opiate use disorder
opioid
back pain
chronic back pain
opioid use
opioid abuse
opioid disorder
low intensity focused ultrasound
transcranial ultrasound

Additional Relevant MeSH Terms

Opioid Use Disorder
Chronic Back Pain
Anxiety