Safety and feasibility clinical trial of nucleus accumbens deep brain stimulation for treatment-refractory opioid use disorder.
Level 4 - case-series / case-control
Prospective single-arm open-label pilot trial (case series) without a control group
PubMed 37329519 · doi:10.3171/2023.4.JNS23114
What was done
A prospective, open-label, single-arm feasibility trial evaluated deep brain stimulation (DBS) targeting the nucleus accumbens (NAc) and ventral capsule (VC) in individuals with longstanding, treatment-refractory opioid use disorder (OUD) and co-occurring substance use disorders. The primary endpoint was safety. Secondary and exploratory outcomes included substance use, cravings, emotional symptoms (depression and anxiety), and brain glucose metabolism measured by 18FDG-PET neuroimaging.
What was found
Four male participants were enrolled and underwent DBS implantation. There were no serious adverse events and no device- or stimulation-related adverse events reported. Two participants maintained complete substance abstinence for > 1150 and > 520 days, respectively, alongside reported reductions in substance cravings, anxiety, and depression. One participant experienced post-DBS drug recurrences with reduced frequency and severity. One participant was explanted due to noncompliance with study and treatment protocols. On 18FDG-PET neuroimaging, only the two participants with sustained abstinence exhibited increased frontal region glucose metabolism.
Why it matters
This study provides preliminary safety and feasibility data for utilizing NAc/VC deep brain stimulation as an experimental neurosurgical intervention in patients with severe, treatment-refractory opioid dependence.
Limits
The study is limited by an extremely small sample size (n=4) consisting entirely of male participants. The open-label, single-arm design lacks a sham or standard-care control group, precluding causal inference regarding efficacy. Additionally, one of the four participants was noncompliant and required device explantation.
Cited by
- supports A patient with refractory addiction received a neurosurgical brain implant for addiction at West Virginia University.