NCT06218706

LIFU for Treatment for Refractory Opioid Use Disorder

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Ali Rezai · Academic / Other
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-09
• Primary completion: 2026-10-30
• Completion: 2028-03-01
• First posted: 2024-01-23
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study