🏛️ Verified NIH Record • Updated 2025-07-16

Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder (NCT03950492)

Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: West Virginia University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (26 items).

Location: West Virginia University Rockefeller Neuroscience Institute — Morgantown, West Virginia

Age range: 21 Years to 50 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Medical problems requiring intensive medical or diagnostic management.
  • Diagnosis of acute myocardial infarction or cardiac arrest within the previous 6 months.
  • History of a neurosurgical ablation procedure.
  • Any medical contraindications to undergoing DBS surgery.
  • History of hemorrhagic stroke.
  • Life expectancy of \<3 years
  • Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5). Any treated depression has to have been in remission for one year.
  • Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or increased risk of suicide based upon any positive response on the Columbia Suicide Severity Scale.
  • Cluster A or B Personality Disorders.
  • Diagnosis of dementia.
  • History of neurological disorder.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • West Virginia University Rockefeller Neuroscience Institute — Morgantown, West Virginia

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗