Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

  • STATUS
    Recruiting
  • days left to enroll
    14
  • participants needed
    3
  • sponsor
    Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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Updated on 14 March 2022
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Summary

This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.

Description

Three (N = 3) subjects with treatment refractory opioid use disorder will receive bilateral DBS implants in the NAc using the Abbott Medical Infinity DBS system. The primary outcome of this study is to demonstrate the safety of bilateral NAc DBS in patients with treatment-refractory opioid use disorder. Secondary outcomes include time to relapse, remission of opioid use, and change in opioid craving scores. Other secondary outcomes will include the following: Hamilton Depression Scale (HDS), neurophysiological tests, body weight and biochemical markers of health and nutrition. If effective, DBS may reduce opioid use and opioid relapse in people with opioid use disorder who may continue to display relapse despite ongoing multidisciplinary standard of care. DBS brain electrode implantation and implantation of the IPGs and extension wires will be done in the operating room and will require the subject to be admitted post-operatively for an overnight stay. Two weeks after the DBS operation, subjects will undergo systematic testing each of the quadripolar contacts and formal programming. Subsequent parameter settings will be changed at routine outpatient visits based on clinical effects. Standard of care can consist of methadone or buprenorphine maintenance treatment provided by an addiction specialist.

Details
Condition Opioid-use Disorder
Treatment DBS of the NAc
Clinical Study IdentifierNCT04354077
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Last Modified on14 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male and females age ≥ 22 years with diagnosis of opioid use disorder (OUD) based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) with at least a 5-year history
OUD must be the primary disorder and the other use disorders must not include consistent use
Failed at least two levels of treatment (Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential, inpatient, alternative to intensive outpatient program, Drug Dependence Unit) which included buprenorphine/naloxone or buprenorphine monotherapy
Had 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)
Demonstrated at least 5 years of refractory symptoms of OUD
Has exhibited more than 2 episodes of opioid use relapse in prior 6 months despite ongoing participation in MAT program, including either methadone or buprenorphine or suboxone
No active ilicit substance abuse as based on urine testing
Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
Karnofsky Performance Score > 60
Platelet count > 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
Negative blood cultures to rule out bacteremia

Exclusion Criteria

Prior brain surgery
Presence of any other substance use disorder that is at a moderate level of severity or greater based on DSM-5 criteria
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
History of suicide attempt
Parental history of completed suicide
Substance abuse treatment mandated by court of law
History of uncontrolled or persistent seizures
Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score < 25
Contraindications for MRI
Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces)
Claustrophobia
Body weight exceeding limit of the machine (180 kg/400 lb)
Females who are pregnant or nursing. Female subjects of child-bearing potential must
have a negative pregnancy test during the pre-op phase and must agree to
utilize adequate birth control throughout the trial and for at least 30 days
following trial completion
Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
History of significant psychiatric disorder (e.g., comorbid schizophrenia, bipolar disorder, suicidal ideation/attempts) that could interfere with interpretation of study endpoints
Any evidence of underlying endocarditis
Primary language other than English
Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment
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