Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

Eligibility 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
• 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. Has exhibited more than 2 episodes of opioid use relapse in prior 12 months despite ongoing participation in MAT program, including either methadone or buprenorphine or suboxone
• 5. No active ilicit substance abuse as based on urine testing
• 6. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
• 7. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
• 8. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
• 9. Platelet count \> 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
• 10. Negative blood cultures to rule out bacteremia
• 1. Prior brain surgery
• 2. 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
• 3. History of suicide attempt in the past 5 years
• 4. History of uncontrolled or persistent seizures
• 5. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \< 25
• 6. 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)
• 7. 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.
• 8. Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
• 9. Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
• 10. Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
• 11. Any evidence of underlying endocarditis.
• 12. Primary language other than English
• 13. Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.