NCT07214467

Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if personalized (adaptive) Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes like reductions in craving and opioid use.

Detailed description

This study will enroll individuals with severe Opioid Use Disorder (OUD) who have not responded to standard treatments. The devices used in this study are investigational, which means they are not approved by the Food and Drug Administration (FDA) to treat OUD. The information we obtain in this study will be used to better understand the mechanisms of OUD in the brain.

Conditions

• Substance Use Disorder (SUD)
• Opioid Use Disorder (OUD)

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	An individualized aDBS protocol will be used to examine therapeutic effect.

Timeline

• Start date: 2025-10-24
• Primary completion: 2031-11-22
• Completion: 2031-11-22
• First posted: 2025-10-09
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study