PMID- 37329519 OWN - NLM STAT- MEDLINE DCOM- 20240103 LR - 20240103 IS - 1933-0693 (Electronic) IS - 0022-3085 (Linking) VI - 140 IP - 1 DP - 2024 Jan 1 TI - Safety and feasibility clinical trial of nucleus accumbens deep brain stimulation for treatment-refractory opioid use disorder. PG - 231-239 LID - 10.3171/2023.4.JNS23114 [doi] AB - OBJECTIVE: There were more than 107,000 drug overdose deaths in the US in 2021, the most ever recorded. Despite advances in behavioral and pharmacological treatments, over 50% of those receiving treatment for opioid use disorder (OUD) experience drug use recurrence (relapse). Given the prevalence of OUD and other substance use disorders (SUDs), the high rate of drug use recurrence, and the number of drug overdose deaths, novel treatment strategies are desperately needed. The objective of this study was to evaluate the safety and feasibility of deep brain stimulation (DBS) targeting the nucleus accumbens (NAc)/ventral capsule (VC) and potential impact on outcomes in individuals with treatment-refractory OUD. METHODS: A prospective, open-label, single-arm study was conducted among participants with longstanding treatment-refractory OUD (along with other co-occurring SUDs) who underwent DBS in the NAc/VC. The primary study endpoint was safety; secondary/exploratory outcomes included opioid and other substance use, substance craving, and emotional symptoms throughout follow-up and 18FDG-PET neuroimaging. RESULTS: Four male participants were enrolled and all tolerated DBS surgery well with no serious adverse events (AEs) and no device- or stimulation-related AEs. Two participants sustained complete substance abstinence for > 1150 and > 520 days, respectively, with significant post-DBS reductions in substance craving, anxiety, and depression. One participant experienced post-DBS drug use recurrences with reduced frequency and severity. The DBS system was explanted in one participant due to noncompliance with treatment requirements and the study protocol. 18FDG-PET neuroimaging revealed increased glucose metabolism in the frontal regions for the participants with sustained abstinence only. CONCLUSIONS: DBS of the NAc/VC was safe, feasible, and can potentially reduce substance use, craving, and emotional symptoms in those with treatment-refractory OUD. A randomized, sham-controlled trial in a larger cohort of patients is being initiated. FAU - Rezai, Ali R AU - Rezai AR AD - 1Departments of Neurosurgery. AD - 2Neuroscience. FAU - Mahoney, James J AU - Mahoney JJ AD - 2Neuroscience. AD - 3Behavioral Medicine and Psychiatry. FAU - Ranjan, Manish AU - Ranjan M AD - 1Departments of Neurosurgery. FAU - Haut, Marc W AU - Haut MW AD - 2Neuroscience. AD - 3Behavioral Medicine and Psychiatry. AD - 4Neurology. AD - 5Radiology, and. FAU - Zheng, Wanhong AU - Zheng W AD - 2Neuroscience. AD - 3Behavioral Medicine and Psychiatry. FAU - Lander, Laura R AU - Lander LR AD - 2Neuroscience. AD - 3Behavioral Medicine and Psychiatry. FAU - Berry, James H AU - Berry JH AD - 2Neuroscience. AD - 3Behavioral Medicine and Psychiatry. FAU - Farmer, Daniel L AU - Farmer DL AD - 2Neuroscience. AD - 3Behavioral Medicine and Psychiatry. FAU - Marton, Jennifer L AU - Marton JL AD - 2Neuroscience. AD - 3Behavioral Medicine and Psychiatry. FAU - Tirumalai, Padma AU - Tirumalai P AD - 2Neuroscience. FAU - Mears, Ashley AU - Mears A AD - 1Departments of Neurosurgery. FAU - Thompson-Lake, Daisy G Y AU - Thompson-Lake DGY AD - 2Neuroscience. FAU - Finomore, Victor S AU - Finomore VS AD - 2Neuroscience. FAU - D'Haese, Pierre-Francois AU - D'Haese PF AD - 10Neuroradiology, West Virginia University School of Medicine, Rockefeller Neuroscience Institute, Morgantown, West Virginia. FAU - Aklin, Will M AU - Aklin WM AD - 6National Institute on Drug Abuse, and. FAU - George, David T AU - George DT AD - 7National Institute on Alcohol Abuse and Addiction, NIH, Bethesda, Maryland. FAU - Corrigan, John D AU - Corrigan JD AD - 8Department of Physical Medicine and Rehabilitation, The Ohio State University, Columbus, Ohio; and. FAU - Hodder, Sally L AU - Hodder SL AD - 9West Virginia Clinical & Translational Science Institute, West Virginia University, Morgantown, West Virginia. LA - eng PT - Journal Article DEP - 20230609 PL - United States TA - J Neurosurg JT - Journal of neurosurgery JID - 0253357 RN - 0Z5B2CJX4D (Fluorodeoxyglucose F18) SB - IM MH - Humans MH - Male MH - Nucleus Accumbens/diagnostic imaging MH - *Deep Brain Stimulation/methods MH - Fluorodeoxyglucose F18 MH - Prospective Studies MH - Feasibility Studies MH - Neoplasm Recurrence, Local MH - *Opioid-Related Disorders/therapy MH - *Drug Overdose OTO - NOTNLM OT - addiction OT - deep brain stimulation OT - functional neurosurgery OT - neuromodulation OT - nucleus accumbens OT - opioid use disorder OT - overdose OT - treatment refractory EDAT- 2023/06/17 19:16 MHDA- 2024/01/03 09:44 CRDT- 2023/06/17 13:13 PHST- 2023/02/01 00:00 [received] PHST- 2023/04/21 00:00 [accepted] PHST- 2024/01/03 09:44 [medline] PHST- 2023/06/17 19:16 [pubmed] PHST- 2023/06/17 13:13 [entrez] AID - 10.3171/2023.4.JNS23114 [doi] PST - epublish SO - J Neurosurg. 2023 Jun 9;140(1):231-239. doi: 10.3171/2023.4.JNS23114. Print 2024 Jan 1.