NCT03950492

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

Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: 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. This study will also provide critical information for planning subsequent clinical trials.

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 Simulator	This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.

Timeline

• Start date: 2019-09-30
• Primary completion: 2022-12-31
• Completion: 2026-12-31
• First posted: 2019-05-15
• Last updated: 2025-07-28
• Results posted: 2024-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study