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出境医 / 临床实验 / 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 Opioid Use Disorder (DBS OUD)

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Device: Deep Brain Simulator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Incidence of Study-Emergent Adverse Events [ Time Frame: 24 - 52 weeks ]
    Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.

  2. Change in Opioid Use [ Time Frame: 24 - 52 weeks ]
    Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.


Secondary Outcome Measures :
  1. Participant Survival [ Time Frame: 12 -52 weeks ]
    Incidence of drug overdose deaths among the participants.

  2. Treatment Retention [ Time Frame: 12 - 52 weeks ]
    Participants' retention in traditional medication assisted treatment (MAT).

  3. Incidence of Serious Infectious Disease Complications [ Time Frame: 12 - 52 weeks ]
    Laboratory tests and evaluation to discern presentation of infectious disease.

  4. Mood, Craving and Executive Function [ Time Frame: 12 and 24 weeks post surgery ]
    Participants will complete standardized measures of mood, drug craving, and executive function at 12 weeks and 24 weeks post DBS titration.


Other Outcome Measures:
  1. Frontal Lobe Metabolism [ Time Frame: 3 weeks and 12 weeks post surgery ]
    18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS

  2. Changes in Dopamine [ Time Frame: 3 weeks and 12 weeks post surgery ]
    C11 Raclopride PET may be used to examine for changes in dopamine at 12 weeks post titration.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Contacts
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Contact: Marc Haut, PhD 304-293-6276 mhaut@hsc.wvu.edu
Contact: Barbara Harring 304-293-9638 barbara.harring@hsc.wvu.edu

Locations
Layout table for location information
United States, West Virginia
West Virginia University Rockefeller Neuroscience Institute Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Marc W Haut, PhD    304-293-6276    mhaut@hsc.wvu.edu   
Contact: Barbara Harring    304-293-9638    barbara.harring@hsc.wvu.edu   
Sponsors and Collaborators
West Virginia University
National Institute on Drug Abuse (NIDA)
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: Ali R Rezai, MD West Virginia University
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Incidence of Study-Emergent Adverse Events [ Time Frame: 24 - 52 weeks ]
    Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.
  • Change in Opioid Use [ Time Frame: 24 - 52 weeks ]
    Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Participant Survival [ Time Frame: 12 -52 weeks ]
    Incidence of drug overdose deaths among the participants.
  • Treatment Retention [ Time Frame: 12 - 52 weeks ]
    Participants' retention in traditional medication assisted treatment (MAT).
  • Incidence of Serious Infectious Disease Complications [ Time Frame: 12 - 52 weeks ]
    Laboratory tests and evaluation to discern presentation of infectious disease.
  • Mood, Craving and Executive Function [ Time Frame: 12 and 24 weeks post surgery ]
    Participants will complete standardized measures of mood, drug craving, and executive function at 12 weeks and 24 weeks post DBS titration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 8, 2019)
  • Frontal Lobe Metabolism [ Time Frame: 3 weeks and 12 weeks post surgery ]
    18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS
  • Changes in Dopamine [ Time Frame: 3 weeks and 12 weeks post surgery ]
    C11 Raclopride PET may be used to examine for changes in dopamine at 12 weeks post titration.
Original Other Pre-specified Outcome Measures
 (submitted: May 13, 2019)
  • Frontal Lobe Metabolism [ Time Frame: 3 weeks and 12 weeks post surgery ]
    18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS
  • Changes in Dopamine [ Time Frame: 3 weeks and 12 weeks post surgery ]
    C11 Raclopride PET will be used to examine for changes in dopamine at 12 weeks post titration.
 
Descriptive Information
Brief Title  ICMJE Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Official Title  ICMJE Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Opioid-Related Disorders
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Deep Brain Simulator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019) 		4
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marc Haut, PhD 304-293-6276 mhaut@hsc.wvu.edu
Contact: Barbara Harring 304-293-9638 barbara.harring@hsc.wvu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03950492
Other Study ID Numbers  ICMJE 1903499841
1UG3DA047714-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ali Rezai, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Medtronic
Investigators  ICMJE
Principal Investigator: Ali R Rezai, MD West Virginia University
PRS Account West Virginia University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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