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Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder | Clinical Trials | Clareo Health

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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

NCT05903495•West Virginia University

View on ClinicalTrials.gov

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.

Eligibility

Age

22 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 22-50 years at time of enrollment.
•Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history.
•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 seeking treatment 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 Criteria

•Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6 months.
•Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced.
•Unable to undergo MR-imaging

Locations (1)

West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, United States

Key Dates

Start Date

July 1, 2023

Primary Completion Date

October 17, 2023

Completion Date

June 28, 2024

Last Updated

March 6, 2026

Enrollment

ACTUAL participants

Conditions

Opioid-Related Disorders

Interventions

Deep Brain Stimulation

DEVICE

Tau PET Imaging in Opioid Use Disorder

NCT05651516

Opioid-Related Disorders

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Tau PET Imaging in Opioid Use Disorder

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