EMPOWER AUD Pivotal Trial

Evaluation of the Empower Neuromodulation System for the Treatment of Alcohol Use Disorder

Multi-site, double-blinded, prospective, randomized, sham-controlled study

To evaluate the safety and effectiveness of the Empower Neuromodulation System in alcohol use disorder (AUD) patients. The primary safety endpoint will be device-related serious adverse events. The primary effectiveness endpoint will be responder rate at 12 weeks, where a responder is defined as a subject who experiences at least a one level reduction in the WHO risk level for daily alcohol consumption from Baseline to Week 12 as measured via the 28-day Timeline Follow-back (TLFB). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.

Inclusion Criteria:

A candidate for this study must meet ALL of the following inclusion criteria:

• Women and men ≥21 years of age
• Individual has a current diagnosis of alcohol use disorder per DSM-5 via M.I.N.I. assessment by clinician
• Individual has a desire to reduce or quit alcohol use
• Based on the 28-day TLFB at enrollment, individual has an average daily alcohol consumption in the WHO risk levels of moderate, high, or very high (men: ≥2.91 drinks/day; women: ≥1.41 drinks/day)
• Individual has a breath alcohol concentration of 0.02% or less at enrollment
• Individual has a negative urine pregnancy test at screening (females of childbearing age only)
• Individual is able to provide informed consent
• Individual is capable and willing to follow all study-related procedures

Exclusion Criteria:

A candidate will be excluded from the study if ANY of the following conditions are met:

• Individual has a current, unstable psychiatric disorder per DSM-5 via M.I.N.I. assessment that is clinically significant enough to preclude study participation per the judgment of the study site PIs
• Individual has been diagnosed with a neurodegenerative disease, including Parkinson's disease, dementia, and Alzheimer's disease
• Individual has a current substance use disorder (SUD) diagnosis other than alcohol, nicotine, or cannabis per DSM-5 via M.I.N.I. assessment by clinician
• Individual requires acute medical detoxification from alcohol per based on a score of 12 or more on the Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar)
• Individual is taking or plans to start taking an AUD pharmacotherapy during the study
• Individual has had a change in AUD pharmacotherapy in the past 4 weeks
• Individual has initiated or discontinued SUD psychotherapy in the past 4 weeks, has had a change in SUD psychotherapy modality in the past 4 weeks, or expects to initiate, discontinue, or change psychotherapy modality during the study
• Individual has an active implant and/or an implanted electrical or neurostimulator device (e.g., pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
• Individual is currently using, or has used in the past 3 months, transcutaneous electrical nerve stimulation (TENS) in the upper extremities
• Individual is currently receiving, or has received in the past 3 months, acupuncture, or acupressure in the upper extremities
• Individual has an electrically conductive metal object (e.g., jewelry) that cannot be removed and will directly contact the gel electrodes of the Empower Neuromodulation System at either treatment location
• Individual has an open incision, wound, scar, active infection or otherwise compromised skin at the treatment locations and will directly contact the gel electrodes of the Empower Neuromodulation System at either anatomic location
• Individual has a history of epilepsy or a seizure disorder
• Individual has been clinically diagnosed with peripheral nerve damage of the upper limbs or has numbness or tingling in an upper limb at least weekly
• Individual is female and currently pregnant or breastfeeding, has been pregnant within the past 6 months, intends to become pregnant during participation in the study, or is unwilling to practice birth control during participation in the study
• Individual will not, for the duration of participation in the study, have a living situation that provides regular access to an electrical outlet for charging the study device and smartphone
• Individual has used an investigational drug, biologic, or medical device in the past 4 weeks
• Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination