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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Deep Brain Stimulation of the Nucleus Accumbens
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGOpioid use/abstinence
Percentage of subjects achieving opioid abstinence
Time frame: 6 months
Opioid use/abstinence
Percentage of subjects achieving opioid abstinence
Time frame: 1 year post-surgery
Changes in biochemical markers of health
Biochemical battery of tests. Blood draw for plasma CBC, lytes, BUN, creatinine, Glutamate dehydrogenase (GLDH), gamma-glutamyltransferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), erythrocyte mean corpuscular volume (MCV), carbohydrate-deficient transferrin (CDT)
Time frame: Baseline, 6, 12 and 24 months
Changes in biochemical markers of nutrition
Biochemical battery of tests. Blood draw for plasma, pre-albumin, folate, B12, calcium, magnesium, iron
Time frame: Baseline, 6, 12 and 24 months
Depression score
Hamilton Depression Scale: There are 17 items by which an assessor will select one cue which best characterizes the patient (0-4). All items are added up for a total score, where lower numbers are indicative of a normal score and higher numbers are indicative of worse depression.
Time frame: Baseline, 3, 6, 9, 12 and 24 months post-surgery
Quality of life measure
Flanagan QOL scale: Subjects will assign a rank score to 16 items. Rankings go from 7 to 1, where 7 is a better outcome and 1 is the worst outcome. The scale is as follows: 7=Delighted, 6=Pleased, 5=Mostly Satisfied, 4=Mixed, 3=Mostly Dissatisfied, 2=Unhappy, 1=Terrible. All rankings are totaled for a final score.
Time frame: Baseline, 3, 6, 9, 12 and 24 months post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.