EMPOWER AUD Pivotal Trial

NCT05948605 | Completed FDA Device

• 1 other identifier: CRD-12-1477-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Alcoholism; Alcohol Abuse; Alcohol Use Disorder

Keywords

Alcoholism; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Frequency of device-related Serious AEs (SAEs)

  The primary safety endpoint will be comparing the frequency of device-related Serious AEs (SAEs) between the Active and Sham Treatment groups, where device-related SAEs include probably and possibly device-related serious adverse events

  Week 12

• Primary Effectiveness Endpoint: Change in WHO risk level via 28-day TLFB

  The primary effectiveness endpoint is the responder rate at Week 12, where a responder is a study subject who experiences ≥1 level reduction in the WHO risk level from Baseline to Week 12 via the 28-day Timeline Follow-back (TLFB), and responder rate is the percentage of participants in a treatment group who are responders

  Week 12

Secondary Outcomes (6)

• Change in Alcohol Craving Intensity via the Penn Alcohol Craving Survey (PACS)

  Week 12

• Change in Heavy Drinking Days (HDD) via 28-day TLFB

  Week 12

• Change in Alcohol Related Problems via SIP

  Week 12

• Change in Alcohol Consumption via PEth analysis

  Week 12

• Change in Alcohol Craving Intensity via daily self reports

  Week 12

Other Outcomes (19)

• Exploratory Effectiveness - Responder Rate Week 6

  Week 6

• Exploratory Effectiveness - Drink reduction Week 12 via TLFB

  Week 12

• Exploratory Effectiveness - % Drink change Week 12 via TLFB

  Week 12

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

The Active Treatment will use a functional Stimulator system.

Device: Empower Neuromodulation System

Sham Treatment

SHAM COMPARATOR

The Sham Treatment (Placebo) will use a functional Stimulator system, but will provide a treatment in a location that is believed to have no benefit or harm to the subject.

Device: Empower Neuromodulation System

Interventions

Empower Neuromodulation System DEVICE

The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses.

Active Treatment; Sham Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theranova, L.L.C.: lead

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Yale University

New Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• KT Venkateswara-Rao, PhD

  TheraNova, LLC

  PRINCIPAL INVESTIGATOR

• David Pennington, PhD

  Northern California Institute of Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Site staff are blinded to the subject's assigned Arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, double-blinded, prospective, randomized, sham-controlled study

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: July 17, 2023
• Study Start: December 1, 2023
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)