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

Primary Purpose

Opioid-Related Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Simulator
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid-Related Disorders focused on measuring Deep Brain Stimulation

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • West Virginia University Rockefeller Neuroscience Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OUD DBS

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Change in Opioid Use
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.

Secondary Outcome Measures

Participant Survival
Incidence of drug overdose deaths among the participants.
Treatment Retention
Participants' retention in traditional medication assisted treatment (MAT).
Incidence of Serious Infectious Disease Complications
Laboratory tests and evaluation to discern presentation of infectious disease.
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.

Full Information

First Posted
May 10, 2019
Last Updated
August 4, 2023
Sponsor
West Virginia University
Collaborators
National Institute on Drug Abuse (NIDA), Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT03950492
Brief Title
Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Acronym
DBS_OUD
Official Title
Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
Collaborators
National Institute on Drug Abuse (NIDA), Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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. This study will also provide critical information for planning subsequent clinical trials.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
Deep Brain Stimulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have deep brain stimulation (DBS) targeting the NAc/VC.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OUD DBS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Deep Brain Simulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Study-Emergent Adverse Events
Description
Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.
Time Frame
24 - 52 weeks
Title
Change in Opioid Use
Description
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.
Time Frame
24 - 52 weeks
Secondary Outcome Measure Information:
Title
Participant Survival
Description
Incidence of drug overdose deaths among the participants.
Time Frame
12 -52 weeks
Title
Treatment Retention
Description
Participants' retention in traditional medication assisted treatment (MAT).
Time Frame
12 - 52 weeks
Title
Incidence of Serious Infectious Disease Complications
Description
Laboratory tests and evaluation to discern presentation of infectious disease.
Time Frame
12 - 52 weeks
Title
Mood, Craving and Executive Function
Description
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
Other Pre-specified Outcome Measures:
Title
Frontal Lobe Metabolism
Description
18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS
Time Frame
3 weeks and 12 weeks post surgery
Title
Changes in Dopamine
Description
C11 Raclopride PET may be used to examine for changes in dopamine at 12 weeks post titration.
Time Frame
3 weeks and 12 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali R Rezai, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University Rockefeller Neuroscience Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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