AlcoholismNCT05948605
EMPOWER AUD Pivotal Trial
A study testing Empower Neuromodulation System in people with Alcoholism and Alcohol Abuse, run by Theranova, L.L.C. at 2 sites in United States.
Trial summary
Multi-site, double-blinded, prospective, randomized, sham-controlled study Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholism, Alcohol Abuse, Alcohol Use Disorder
- What is being tested?
- Empower Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2023to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale University
New Haven, Connecticut, 06516
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Evaluation of the Empower Neuromodulation System for the Treatment of Alcohol Use Disorder
Multi-site, double-blinded, prospective, randomized, sham-controlled study
Read the detailed description
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.
- Conditions
- Alcoholism, Alcohol Abuse, Alcohol Use Disorder
- Being tested
- Empower Neuromodulation System
- Keywords
- Alcoholism, Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower Neuromodulation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | The Active Treatment will use a functional Stimulator system. Receives: 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. Receives: Device: Empower Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 12
Secondary outcomes (6)
Change in Alcohol Craving Intensity via the Penn Alcohol Craving Survey (PACS)
Change in alcohol craving intensity. The change in alcohol craving intensity as assessed via the Penn Alcohol Craving Survey (PACS) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. The scale has a range of 0-30 where a higher score indicates more severe cravings.
Measured: Week 12
Change in Heavy Drinking Days (HDD) via 28-day TLFB
Change in heavy drinking days (HDD). The change in HDD as assessed via the 28-day Timeline Follow-Back (TLFB) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups, where a HDD is defined as 5 or more drinks for men and 4 or more drinks for women in one calendar day
Measured: Week 12
Change in Alcohol Related Problems via SIP
Change in alcohol-related problems. The change in alcohol-related problems as assessed via the Short Index of Problems (SIP) from Baseline to Week 12 will be compared between the Active and Sham Treatment groups. The total score has a range of 0-15 where a higher total indicates more problems.
Measured: Week 12
Change in Alcohol Consumption via PEth analysis
Change in phosphatidylethanol (PEth)-based evaluation of alcohol consumption. The change in alcohol consumption as assessed via PEth analysis from Baseline to Week 12 will be compared between the Active and Sham Treatment groups.
Measured: Week 12
Change in Alcohol Craving Intensity via daily self reports
Change in daily alcohol craving intensity. The change in daily alcohol craving intensity as assessed via daily self-reports on the Empower app (100-point Visual Analog Scale (VAS)) from Week 1 to Week 12 will be compared between the Active and Sham Treatment groups. The scale range is 0-100, where the higher rating indicates higher level of alcohol cravings.
Measured: Week 12
Improvement in Clinician Assessment of Illness via CGI
Improvement in clinician assessment of illness. The clinician assessment of improvement in illness as assessed via Clinical Global Impression (CGI) at Week 12 will be compared between the Active and Sham Treatment groups.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Dec 2023
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, double-blinded, prospective, randomized, sham-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KT Venkateswara-Rao, PhD, Principal investigator, TheraNova, LLCDavid Pennington, PhD, Principal investigator, Northern California Institute of Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948605
- Sponsor's protocol ID
- CRD-12-1477-01
- Status last verified
- Aug 2025
- First submitted
- 12 May 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Empower Neuromodulation System for the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05948605
- Acronym / sponsor ID
- CRD-12-1477-01
- Conditions
- Alcoholism, Alcohol Abuse, Alcohol Use Disorder
- Keywords
- Alcoholism, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-site, double-blinded, prospective, randomized, sham-controlled study
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multi-center, double-blinded, prospective, randomized, sham-controlled study
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: Empower Neuromodulation SystemThe Active Treatment will use a functional Stimulator system. |
| Sham Treatment | Sham comparator | Device: Empower Neuromodulation SystemThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empower Neuromodulation SystemThe 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. | Device | Active Treatment, Sham Treatment |
Primary outcome
Primary Safety Endpoint: Frequency of device-related Serious AEs (SAEs)
Time frame: Week 12
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
Primary Effectiveness Endpoint: Change in WHO risk level via 28-day TLFB
Time frame: Week 12
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
6 secondary outcomes
Change in Alcohol Craving Intensity via the Penn Alcohol Craving Survey (PACS)
Time frame: Week 12
Change in Heavy Drinking Days (HDD) via 28-day TLFB
Time frame: Week 12
Change in Alcohol Related Problems via SIP
Time frame: Week 12
Change in Alcohol Consumption via PEth analysis
Time frame: Week 12
Change in Alcohol Craving Intensity via daily self reports
Time frame: Week 12
Improvement in Clinician Assessment of Illness via CGI
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KT Venkateswara-Rao, PhD principal investigator
TheraNova, LLC
David Pennington, PhD principal investigator
Northern California Institute of Research and Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empower Neuromodulation System in people with Alcoholism and Alcohol Abuse, run by Theranova, L.L.C. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Frequency of device-related Serious AEs (SAEs) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.