RecruitingNot ApplicableNCT04354077

Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) for Patients With Treatment-refractory Opioid Use Disorder


Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Enrollment

3 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 65 Years

Inclusion Criteria9

  • 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 Criteria15

  • 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.

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Interventions

DEVICEDBS of the NAc

Deep Brain Stimulation of the Nucleus Accumbens


Locations(1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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NCT04354077


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