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. This study will also provide critical information for planning subsequent clinical trials.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
4
This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States
Total Number of Study-Emergent Adverse Events
Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.
Time frame: Enrollment - 52 weeks
Change in Opioid Use
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.
Time frame: 12 weeks
Participant Survival
Incidence of drug overdose deaths among the participants.
Time frame: 12 -52 weeks
Treatment Retention
Participants' retention in traditional medication assisted treatment (MAT).
Time frame: 12 - 52 weeks
Incidence of Serious Infectious Disease Complications
Laboratory tests and evaluation to discern presentation of infectious disease.
Time frame: 12 - 52 weeks
Mood, Craving and Executive Function
Participants will complete standardized measures of mood, drug craving, and executive function at 12 weeks and 24 weeks post DBS titration.
Time frame: 12 and 24 weeks post surgery
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