NCT05903495

Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

A Randomized, Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the nucleus accumbens (NAc) and ventral internal capsule (VC) for participants with treatment refractory opioid use disorder (OUD) who have cognitive, behavioral, and functional disability.

Detailed description

The overarching goal of this study is to evaluate the safety, tolerability, feasibility and impact on outcomes of NAc/VC DBS for treatment refractory OUD. In treatment refractory OUD, innovative approaches and more invasive interventions including DBS are warranted to improve outcomes.

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-10-17
• Completion: 2024-06-28
• First posted: 2023-06-15
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study