Recruiting

LIFU

Sponsor:

Ali Rezai

Code:

NCT06218706

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

Interventions

Low Intensity Focussed Ultrasound

Study Details

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.

Conditions

Opioid Use Disorder

Study ID

NCT06218706

Start date

May 9, 2024

Status verified date

Feb, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LIFU Treatment

sham comparator: Sham treatment

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

Primary outcome measure

  • Occurrence of Treatment Emergent Adverse Events [ Time Frame: Post-ExAblate Procedure through 90 day Follow-Up ]
  • Changes in Opioid Use [ Time Frame: Post-ExAblate Procedure through 90 day Follow-Up ]

Central Contacts and Locations

Central contacts

James Mahoney

3042935323jsmes.mahoney@hsc.wvu.edu

Jennifer Marton

3042935886jennifer.marton@hsc.wvu.edu

Locations

WVU Rockefeller Neuroscience Institute

Recruiting

Morgantown, West Virginia, United States, 26505

More Information

Sponsor

Ali Rezai

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ali Rezai on 2026-02-17.