Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

A Randomized, Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the nucleus accumbens (NAc) and ventral internal capsule (VC) for participants with treatment refractory opioid use disorder (OUD) who have cognitive, behavioral, and functional disability.

The overarching goal of this study is to evaluate the safety, tolerability, feasibility and impact on outcomes of NAc/VC DBS for treatment refractory OUD. In treatment refractory OUD, innovative approaches and more invasive interventions including DBS are warranted to improve outcomes.

Inclusion Criteria:

• Age 22-50 years at time of enrollment.
• Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history.
• Participants may have comorbid SUD diagnoses at a mild, moderate or severe level, however, OUD must be the primary disorder for which the individual is seeking treatment and the other use disorders must occur in the context of relapse.
• At least one lifetime overdose survival.
• Demonstrated greater than five years of refractory symptoms of OUD.

Exclusion Criteria:

• Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6 months.
• Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced.
• Unable to undergo MR-imaging