RecruitingNot Applicable

Focused Ultrasound for the Complex Patient

United States25 participantsStarted 2024-04-29

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Males and females aged 18-75 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.
✓. Participants must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPI-SF)
✓. 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.
✓. Be in treatment for 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 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5).

Exclusion criteria

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: immediately prior to 1 session low-intensity focused ultrasound (LIFU) and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post sham

Trial details

NCT IDNCT06453109

SponsorWashington D.C. Veterans Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Mary R Lee, MD

202-745-8000 mary.lee3@va.gov

View on ClinicalTrials.gov More Opioid Use Disorder trials