EFFICACY AND SAFETY OF DUAL-TARGET DEEP BRAIN STIMULATION FOR TREATMENT-RESISTANT ALCOHOL USE DISORDER: PROTOCOL FOR A MULTI-CENTER, SINGLE ARM, PROSPECTIVE STUDY

Abstract Background Alcohol use disorder (AUD) is the most common, costly, and lethal substance use disorder worldwide, with a rising prevalence. Case reports and animal studies suggest deep brain stimulation (DBS) may be an effective harm-reduction treatment in AUD. Aims & Objectives The aim of this study is to explore whether deep stimulating the nucleus accumbens (NAc) and anterior limb of internal capsule (ALIC) simultaneously may have a synergistic effect against treatment-resistant AUD. Method Total of 12 subjects from two centers (Shanghai Mental Health Center and The Second Xiangya Hospital of Central South University) who fit inclusion and exclusion criteria are recruited to undergo neurosurgical implantation of dual-target DBS in bilateral NAc and ALIC on a certain date, the DBS system will be turned on for stimulation and parameters adjusted 10-14 days after implantation. Clinical observations will be follow-up during the 9-32 weeks after DBS system has been turned on. The primary outcome is the performance on alcohol use self-report which will be carried out regularly every three days during the study period. Safety assessments will include adverse event reporting, clinical laboratory tests, vital signs, and prior/concomitant medications. Results This study is recruiting subjects now, and all results will be reported after study completion. Discussion & Conclusion The study will provide evidence for the efficacy and safety of dual-target DBS for treatment-resistant AUD. This abstract describes the design and methodology of the study. Trial Registration ClinicalTrials.gov ID NCT05786872 References None.