LIFU for Treatment for Refractory Opioid Use Disorder
NCT06218706 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-02-17
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
Interventions
- DEVICE
-
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
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Ali Rezai
lead OTHER
Principal Investigators
-
Ali Rezai · Executive Director WVU Rockefeller Neuroscience Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 22 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-09
- Primary Completion
- 2026-10-30
- Completion
- 2028-03-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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