NCT07010016

Neuromodulation in Substance Use Disorders

Early Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Opioid Use Disorder and/or Other Substance Use Disorders

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Manish Ranjan · Academic / Other
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.

Detailed description

This is an open-label early feasibility study investigating low intensity FUS targeting the NAc/VC for participants with OUD and/or other SUDs. Once participants are deemed eligible following Screening/Baseline, participants will undergo FUS in the bilateral NAc/VC with Behavioral and Substance Craving assessments performed prior to, during, and following the treatment. Participants will be assessed during follow-up visits on Day 1, Week 1, 4, 8, and 12.

Conditions

• Substance Use Disorder

Interventions

Type	Name	Description
DEVICE	NaviFus Model101	FUS Neuromodulation

Timeline

• Start date: 2025-08-07
• Primary completion: 2027-07-30
• Completion: 2028-07-30
• First posted: 2025-06-08
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study