Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

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-5) with at least a 5-year history
• OUD must be the primary disorder
• History of ongoing or previous opioid use, relapse, and/or cravings, despite attempts at, or attendance in, at least two different treatment modalities. These modalities may include: Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential treatment, inpatient treatment, alternative to intensive outpatient programs, Drug Dependence Unit programs, medication-assisted treatment (MAT), medication assisted recovery (MAR), inpatient or outpatient rehabilitation, detox programs, Narcotics Anonymous, individual or group therapy, Partial Hospitalization Programs (PHP), Sober living homes, or similar interventions.
• Self-reports ongoing opioid cravings.
• 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
• 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
• Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or moderate risk of suicide based upon a score of 3 or greater on the Columbia Suicide Severity Scale, unless clinical judgment indicates that the individual is appropriate for inclusion despite these scores.
• 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
• 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.