Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Deep Brain Stimulation, Addiction, Nucleus Accumbens Read More

Inclusion Criteria:

1. 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
2. OUD must be the primary disorder and the other use disorders must not include consistent use
3. 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.
4. 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)
5. Demonstrated at least 5 years of refractory symptoms of OUD
6. 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
7. No active ilicit substance abuse as based on urine testing
8. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
9. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
10. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
11. Karnofsky Performance Score > 60
12. Platelet count > 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
13. Negative blood cultures to rule out bacteremia

Exclusion Criteria:

1. Prior brain surgery
2. Presence of any other substance use disorder that is at a moderate level of severity or greater based on DSM-5 criteria
3. 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
4. History of suicide attempt
5. Parental history of completed suicide
6. Substance abuse treatment mandated by court of law
7. History of uncontrolled or persistent seizures
8. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score < 25

9. Contraindications for MRI:

   1. Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces).
   2. Claustrophobia
   3. Body weight exceeding limit of the machine (180 kg/400 lb)
10. 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.
11. Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
12. Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
13. Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
14. History of significant psychiatric disorder (e.g., comorbid schizophrenia, bipolar disorder, suicidal ideation/attempts) that could interfere with interpretation of study endpoints.
15. Any evidence of underlying endocarditis.
16. Primary language other than English
17. Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.