LIFU for Treatment for Refractory Opioid Use Disorder

NCT ID: NCT06218706

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2028-03-01

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.

Detailed Description

The overall objective of this study is to assess the safety, tolerability, and feasibility of using Low Intensity Focused Ultrasound (LIFU) to treat opioid use disorder (OUD) as well as investigate the potential impact on substance use and risk factors associated with drug use recurrence.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LIFU Treatment

Group Type: EXPERIMENTAL

Low Intensity Focussed Ultrasound

Intervention Type: DEVICE

The major objective of this study is to further test safety, tolerability, and feasibility of LIFU in this population as well as investigate the impact of LIFU on opioid and other substance use. The primary endpoint is 90 days (Post-LIFU Week 12) following Active/Sham LIFU. After the primary endpoint is reached, the blind will be broken and the group who received Sham LIFU will cross-over and receive Active LIFU

Sham treatment

Group Type: SHAM_COMPARATOR

Low Intensity Focussed Ultrasound

Intervention Type: DEVICE

The major objective of this study is to further test safety, tolerability, and feasibility of LIFU in this population as well as investigate the impact of LIFU on opioid and other substance use. The primary endpoint is 90 days (Post-LIFU Week 12) following Active/Sham LIFU. After the primary endpoint is reached, the blind will be broken and the group who received Sham LIFU will cross-over and receive Active LIFU

Interventions

Low Intensity Focussed Ultrasound

The major objective of this study is to further test safety, tolerability, and feasibility of LIFU in this population as well as investigate the impact of LIFU on opioid and other substance use. The primary endpoint is 90 days (Post-LIFU Week 12) following Active/Sham LIFU. After the primary endpoint is reached, the blind will be broken and the group who received Sham LIFU will cross-over and receive Active LIFU

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Ali Rezai

OTHER

Sponsor Role: lead

Responsible Party

Ali Rezai

Director RNI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ali Rezai

Role: PRINCIPAL_INVESTIGATOR

Executive Director WVU Rockefeller Neuroscience Institute

Locations

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James Mahoney

Role: CONTACT

jsmes.mahoney@hsc.wvu.edu

3042935323

Jennifer Marton

Role: CONTACT

jennifer.marton@hsc.wvu.edu

3042935886

Facility Contacts

James Mahoney, PhD

Role: primary

Other Identifiers

2312890071

Identifier Type: -

Identifier Source: org_study_id