N/A
Completed N=1
Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Opioid-Related Disorders
Source: ClinicalTrials.gov NCT05903495 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Safety and Tolerability as Measured by All Adverse Events Related to DBS — 3; 0; 3; 1 Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability as Measured by All Adverse Events Related to DBS |
3; 0; 3; 1; 2; 1 | — |
| PRIMARY Opioid Use Assessed Via Quantitative Urine Toxicology |
1; 0 | — |
| SECONDARY Changes in the Brain Reward Circuitry (FDG PET) |
— | — |
| SECONDARY Changes in the Brain Reward Circuitry (Fallypride PET) |
— | — |
| SECONDARY Changes in Non-Cue Induced Substance Craving (Visual Analog Scale) |
— | — |
| SECONDARY Changes in Cue-Induced Substance Craving (Visual Analog Scale) |
— | — |
| SECONDARY Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale) |
— | — |
| SECONDARY Changes in Cognitive Functioning (NIH Toolbox Cognition Battery) |
— | — |
| SECONDARY Changes in Cognitive Functioning (Standard Neuropsychological Battery) |
— | — |
| SECONDARY Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05903495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.