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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2024-05-09 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 clinically significant by the investigator). * History of stroke or brain lesion in the targeted brain region (the NAc, ventral striatum, or VC). * Implanted neurostimulators (e.g., vagus nerve stimulator, spinal cord stimulator, DBS). * Documentation of clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments. * More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. * Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area. * Subject with impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 * Hepatic function laboratory values which are \> 1.5 times the upper limit of normal unless deemed not clinically significant by a study investigator. * Past or present diagnosis of schizophrenia or psychotic disorder. * Subject unwilling to attempt abstinence from illicit substance use during the course of the study. * Unable to speak, read and understand English. * Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
Contact & Investigator
Ali Rezai
PRINCIPAL INVESTIGATOR
Executive Director WVU Rockefeller Neuroscience Institute
Frequently Asked Questions
Who can join the NCT06218706 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 60 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06218706 currently recruiting?
Yes, NCT06218706 is actively recruiting participants. Contact the research team at jsmes.mahoney@hsc.wvu.edu for enrollment information.
Where is the NCT06218706 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT06218706 clinical trial?
NCT06218706 is sponsored by Ali Rezai. The principal investigator is Ali Rezai at Executive Director WVU Rockefeller Neuroscience Institute. The trial plans to enroll 34 participants.