Clinical trial NCT03950492: Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Official title: Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: Deep Brain Stimulation
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Medtronic
First posted: 2019-05-15
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Total Number of Study-Emergent Adverse Events
timeFrame: Enrollment - 52 weeks
measure: Change in Opioid Use
timeFrame: 12 weeks
Secondary outcomes:
measure: Participant Survival
timeFrame: 12 -52 weeks
measure: Treatment Retention
timeFrame: 12 - 52 weeks
measure: Incidence of Serious Infectious Disease Complications
timeFrame: 12 - 52 weeks
measure: Mood, Craving and Executive Function
timeFrame: 12 and 24 weeks post surgery
Other outcomes:
measure: Frontal Lobe Metabolism
timeFrame: 3 weeks and 12 weeks post surgery
measure: Changes in Dopamine
timeFrame: 3 weeks and 12 weeks post surgery
Locations:
city: Morgantown
country: United States
facility: West Virginia University Rockefeller Neuroscience Institute
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Ali R Rezai, MD
role: PRINCIPAL_INVESTIGATOR
References: