NCT06218706 LIFU for Treatment for Refractory Opioid Use Disorder
| NCT ID | NCT06218706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ali Rezai |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2024-05-09 |
| Primary Completion | 2026-10-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.
Eligibility Criteria
Inclusion Criteria: * Aged 22 - 60 years at time of enrollment. * Fulfill current DSM-5 (American Psychiatric Association diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for severe OUD with at least a 2-year history. * Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception. Exclusion Criteria: * Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia) or cannot lie comfortably on their back for 2-3 hours. * History of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinic