Adults 22 to 50, any sex, with Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and Tolerability as Measured by All Adverse Events Related to DBSPrimary· Outpatient Week 12
Incidence of Study-Emergent Adverse Events. The safety/tolerability primary endpoint will be assessed comparing Grade 3 and 4 adverse events between the Active (DBS-ON) and Sham (DBS-OFF) arms throughout Phase IV (Outpatient Week 12). We will also categorize adverse events by organ system and assess relatedness to any aspect of this proof-of-concept study. Statistical tests will be performed at the request of the Data and Safety Monitoring Board (DSMB).
Total Mild AEs
Group
Value
95% CI
DBS-ON Only
3
Mild AE - Expected
Group
Value
95% CI
DBS-ON Only
0
Mild AE - Unexpected
Group
Value
95% CI
DBS-ON Only
3
Mild AE - Probably Related (Disorder)
Group
Value
95% CI
DBS-ON Only
1
Mild AE - Unrelated
Group
Value
95% CI
DBS-ON Only
2
Total Moderate AEs
Group
Value
95% CI
DBS-ON Only
1
Moderate AE - Unexpected
Group
Value
95% CI
DBS-ON Only
1
Moderate AE - Expected
Group
Value
95% CI
DBS-ON Only
0
Opioid Use Assessed Via Quantitative Urine ToxicologyPrimary· Outpatient Week 12
Opioid use will be evaluated through the use of quantitative urine toxicology using gas chromatography/mass spectrometry. The primary outcome comparison between the active and sham arms will be based off participants with undetectable opioid metabolites (assessed via quantitative urine toxicology) throughout the primary Outpatient Week 12 endpoint.
Number of Participant's Opioid Negative through 12 Week Endpoint
Group
Value
95% CI
DBS-ON Only
1
Number of Participant's Opioid Positive through 12 Week Endpoint
Group
Value
95% CI
DBS-ON Only
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Outpatient Week 12.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06924086 — The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial
· NA
· recruiting
NCT07369401 — Deep Brain Stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the Treatment of Refractory
· NA
· not yet recruiting
NCT07214467 — Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
· NA
· recruiting
NCT06991335 — VC/VS for Apathy in PD
· NA
· not yet recruiting
NCT07049003 — Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
· Phase 1
· recruiting
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Other West Virginia University trials
Trials by the same sponsor.
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· recruiting
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· recruiting
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· recruiting
NCT05353244 — Effects of PrTMS on Performance
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· withdrawn
NCT06612788 — Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD)
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· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by West Virginia University
Last refreshed: 6 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05903495.