Clinical trial NCT04354077: Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
Official title: Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) for Patients With Treatment-refractory Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Deep Brain Stimulation
Addiction
Nucleus Accumbens
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2020-04-21
Enrollment: 3
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.

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 to demonstrate the safety of bilateral NAc DBS in patients with treatment-refractory opioid use disorder. Secondary outcomes include time to relapse, remission of opioid use, and change in opioid craving scores. Other secondary outcomes will include the following: Hamilton Depression Scale (HDS), neurophysiological tests, body weight and biochemical markers of health and nutrition. If effective, DBS may reduce opioid use and opioid relapse in people with opioid use disorder who may continue to display relapse despite ongoing multidisciplinary standard of care. DBS brain electrode implantation and implantation of the IPGs and extension wires will be done in the operating room and will require the subject to be admitted post-operatively for an overnight stay. Two weeks after the DBS operation, subjects will undergo systematic testing each of the quadripolar contacts and formal programming. Subsequent parameter settings will be changed at routine outpatient visits based on clinical effects. Standard of care can consist of methadone or buprenorphine maintenance treatment provided by an addiction specialist.

Eligibility criteria: 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
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

Exclusion Criteria:

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.

Primary outcomes:
measure: Opioid use/abstinence
timeFrame: 6 months
measure: Opioid use/abstinence
timeFrame: 1 year post-surgery
Secondary outcomes:
measure: Changes in biochemical markers of health
timeFrame: Baseline, 6, 12 and 24 months
measure: Changes in biochemical markers of nutrition
timeFrame: Baseline, 6, 12 and 24 months
measure: Depression score
timeFrame: Baseline, 3, 6, 9, 12 and 24 months post-surgery
measure: Quality of life measure
timeFrame: Baseline, 3, 6, 9, 12 and 24 months post-surgery
Other outcomes:
measure: Primary Safety Objective - Complication rates
timeFrame: 12 months
Locations:
city: Pittsburgh
country: United States
facility: AHN Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network
name: Nestor Tomycz, MD
role: PRINCIPAL_INVESTIGATOR
References: