Status:
RECRUITING
Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborating Sponsors:
Abbott
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief 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 stud...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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
- 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
- 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
- Prior brain surgery
- 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 in the past 5 years
- 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.
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04354077
Start Date
February 7 2022
End Date
December 1 2026
Last Update
January 27 2025
Active Locations (1)
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1
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212