University of California, San Francisco
The purpose of this study is to determine if personalized (adaptive) Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes like reductions in craving and opioid use.
This study will enroll individuals with severe Opioid Use Disorder (OUD) who have not responded to standard treatments. The devices used in this study are investigational, which means they are not approved by the Food and Drug Administration (FDA) to treat OUD. The information we obtain in this study will be used to better understand the mechanisms of OUD in the brain.
Inclusion Criteria: * Adults (all genders) 22 to 75 years old. * Current diagnosis of severe primary opioid use disorder (OUD) (\>= 6 on DSM-5 OUD criteria) (any form of opioid use). * History of opioid use for more than 5 years. * Participants are seeking treatment for their OUD. * Participants have insight into their opioid use disorder (score \> 26 on the recognition subscale of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES V.8)) * OUD is treatment refractory: unable to achieve sustained remission over the past 5 years, despite at least three treatment attempts (ou…
An individualized aDBS protocol will be used to examine therapeutic effect.
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