A Randomized, Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Deep Brain Stimulation
- Conditions
- Opioid-Related Disorders
- Sponsor
- West Virginia University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability as Measured by All Adverse Events Related to DBS
- Status
- Completed
- Last Updated
- last month
Overview
Brief 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.
Investigators
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
Arms & Interventions
DBS-ON Only
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remaineder of the study.
Intervention: Deep Brain Stimulation
DBS-OFF, then DBS-ON
Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study.
Intervention: Deep Brain Stimulation
Outcomes
Primary Outcomes
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Time Frame: 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).
Opioid Use Assessed Via Quantitative Urine Toxicology
Time Frame: 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.
Secondary Outcomes
- Changes in Cue-Induced Substance Craving (Visual Analog Scale)(Change from Baseline versus Outpatient Week 12)
- Changes in Cognitive Functioning (Standard Neuropsychological Battery)(Change from Baseline versus Outpatient Week 12)
- Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)(Change from Baseline versus Outpatient Week 12)
- Changes in the Brain Reward Circuitry (FDG PET)(Change from Baseline versus Outpatient Week 12)
- Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale)(Change from Baseline versus Outpatient Week 12)
- Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting)(Change from Baseline versus Outpatient Week 12)
- Changes in the Brain Reward Circuitry (Fallypride PET)(Change from Baseline versus Outpatient Week 12)
- Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)(Change from Baseline versus Outpatient Week 12)