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.
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.
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
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Lead sponsor
Abbott
Collaborator