Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

West Virginia University1 enrolled

Overview

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.

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

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Opioid-Related Disorders

Interventions

Deep Brain StimulationDEVICE

randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

Safety and Tolerability as Measured by All Adverse Events Related to DBS

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).

Time frame: Outpatient Week 12

Opioid Use Assessed Via Quantitative Urine Toxicology

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.

Time frame: Outpatient Week 12

Secondary Outcomes

Changes in the Brain Reward Circuitry (FDG PET)

Changes in the reward circuitry via evaluating prefrontal cortex glucose metabolism (FDG PET)

Time frame: Change from Baseline versus Outpatient Week 12

Changes in the Brain Reward Circuitry (Fallypride PET)

Changes in the reward circuitry via evaluating dopamine in the basal ganglia and NAc (18F-fallypride PET).

Time frame: Change from Baseline versus Outpatient Week 12

Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)

Substance craving without cues: Substance craving will be assessed using a visual analog scale (VAS) where participants are asked to rate their craving. Participants will be asked "How much do you crave \[insert substance name\] right now?". Scale: 0 to 10 where 0 = no craving and 10 = maximum craving

Data from ClinicalTrials.gov

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