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

Last updated: December 17, 2024
Sponsor: West Virginia University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Deep Brain Stimulation

Clinical Study ID

NCT05903495
2301715195
  • Ages 22-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 22-50 years at time of enrollment.

  • Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-yearhistory.

  • Participants may have comorbid SUD diagnoses at a mild, moderate or severe level,however, OUD must be the primary disorder for which the individual is seekingtreatment and the other use disorders must occur in the context of relapse.

  • At least one lifetime overdose survival.

  • Demonstrated greater than five years of refractory symptoms of OUD.

Exclusion

Exclusion Criteria:

  • Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6months.

  • Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, oruntreated depression other than one determined to be substance induced.

  • Unable to undergo MR-imaging

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation
Phase:
Study Start date:
July 07, 2023
Estimated Completion Date:
October 15, 2026

Study 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.

Connect with a study center

  • West Virginia University Rockefeller Neuroscience Institute

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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