Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder (DBS_OUD)

Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: Device: Deep Brain Simulator

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Rockefeller Neuroscience Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Fulfills current DSM-5 (American Psychiatric Association Diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for OUD (severe) and at least a 5-year history.
• Participants may have comorbid SUD diagnoses at mild, moderate or severe levels, 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
• Failed at least two levels of treatment (outpatient/Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient/intensive COAT, residential, inpatient, Adult Intensive Outpatient Program (AIOP), Dual Diagnosis Unit (DDU), which included buprenorphine/naloxone.
• At least two overdose survivals or one overdose survival and one life-threatening infectious disease complication with relapse after treatment (e.g., endocarditis with valve repair/replacement) within the past 1 year.
• Family/Social Support/Involvement (as assessed via the Multidimensional Scale of Perceived Social Support).
• Is able to provide informed consent.

Exclusion Criteria:

• Medical problems requiring intensive medical or diagnostic management.
• Diagnosis of acute myocardial infarction or cardiac arrest within the previous 6 months.
• History of a neurosurgical ablation procedure.
• Any medical contraindications to undergoing DBS surgery.
• History of hemorrhagic stroke.
• Life expectancy of <3 years
• Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5). Any treated depression has to have been in remission for one year.
• Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or increased risk of suicide based upon any positive response on the Columbia Suicide Severity Scale.
• Cluster A or B Personality Disorders.
• Diagnosis of dementia.
• History of neurological disorder.
• History of previous neurosurgery (brain) or head trauma.
• History of suicide attempt.
• Parental history of completed suicide.
• Abnormal coagulation lab studies or uncontrolled hypertension.
• Implanted neurostimulators.
• Any current CNS infection or infection with the Human Immunodeficiency Virus (HIV).
• Unable to undergo MR-imaging.
• Documentation of MRI abnormality indicative of a neurological condition.
• Substance abuse treatment mandated by court of law.
• Pregnant or planning to become pregnant.
• Conditions requiring diathermy.
• Anticoagulant treatment.
• Primary language other than English.
• Any evidence of systemic infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OUD DBS; This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.	Device: Deep Brain Simulator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Study-Emergent Adverse Events	Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.	24 - 52 weeks
Change in Opioid Use	Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.	24 - 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Survival	Incidence of drug overdose deaths among the participants.	12 -52 weeks
Treatment Retention	Participants' retention in traditional medication assisted treatment (MAT).	12 - 52 weeks
Incidence of Serious Infectious Disease Complications	Laboratory tests and evaluation to discern presentation of infectious disease.	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.	12 and 24 weeks post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontal Lobe Metabolism	18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS	3 weeks and 12 weeks post surgery
Changes in Dopamine	C11 Raclopride PET may be used to examine for changes in dopamine at 12 weeks post titration.	3 weeks and 12 weeks post surgery

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: National Institute on Drug Abuse (NIDA); Medtronic
• Investigators: Principal Investigator: Ali R Rezai, MD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 1903499841; 1UG3DA047714-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes