RECRUITING

LIFU for Treatment for Refractory Opioid Use Disorder

Conditions

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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

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.

Official Title

A Randomized, Sham-Controlled Trial Investigating Low Intensity Focused Ultrasound as a Novel Treatment for Refractory Opioid Use Disorder

Quick Facts

Study Start:2024-05-09

Study Completion:2028-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06218706

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:22 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

James Mahoney

CONTACT

3042935323

jsmes.mahoney@hsc.wvu.edu

Jennifer Marton

CONTACT

3042935886

jennifer.marton@hsc.wvu.edu

Principal Investigator

Ali Rezai

PRINCIPAL_INVESTIGATOR

Executive Director WVU Rockefeller Neuroscience Institute

Study Locations (Sites)

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505

United States

Collaborators and Investigators

Sponsor: Ali Rezai

Ali Rezai, PRINCIPAL_INVESTIGATOR, Executive Director WVU Rockefeller Neuroscience Institute

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 Date2024-05-09

Study Completion Date2028-03-01

Study Record Updates

Study Start Date2024-05-09

Study Completion Date2028-03-01

Terms related to this study

Additional Relevant MeSH Terms

Opioid Use Disorder