Clinical trial NCT05948605: EMPOWER AUD Pivotal Trial
Official title: Evaluation of the Empower Neuromodulation System for the Treatment of Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcoholism
Alcohol Abuse
Alcohol Use Disorder
Keywords: Alcoholism
Alcohol Use Disorder
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
First posted: 2023-07-17
Enrollment: 128
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, double-blinded, prospective, randomized, sham-controlled study
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint: Frequency of device-related Serious AEs (SAEs)
timeFrame: Week 12
measure: Primary Effectiveness Endpoint: Change in WHO risk level via 28-day TLFB
timeFrame: Week 12
Secondary outcomes:
measure: Change in Alcohol Craving Intensity via the Penn Alcohol Craving Survey (PACS)
timeFrame: Week 12
measure: Change in Heavy Drinking Days (HDD) via 28-day TLFB
timeFrame: Week 12
measure: Change in Alcohol Related Problems via SIP
timeFrame: Week 12
measure: Change in Alcohol Consumption via PEth analysis
timeFrame: Week 12
measure: Change in Alcohol Craving Intensity via daily self reports
timeFrame: Week 12
measure: Improvement in Clinician Assessment of Illness via CGI
timeFrame: Week 12
Other outcomes:
measure: Exploratory Effectiveness - Responder Rate Week 6
timeFrame: Week 6
measure: Exploratory Effectiveness - Drink reduction Week 12 via TLFB
timeFrame: Week 12
measure: Exploratory Effectiveness - % Drink change Week 12 via TLFB
timeFrame: Week 12
measure: Exploratory Effectiveness - Drinks change at Week 6
timeFrame: Week 6
measure: Exploratory Effectiveness - Drink change Week 12 via App
timeFrame: Week 12
measure: Exploratory Effectiveness - % Drink change Week 12 via App
timeFrame: Week 12
measure: Exploratory Effectiveness - Drink change Week 6 via App
timeFrame: Week 6
measure: Exploratory Effectiveness - Change in HDD at Week 6 via TLFB
timeFrame: Week 6
measure: Exploratory Effectiveness - Abstinence at Week 12 via TLFB
timeFrame: Week 12
measure: Exploratory Effectiveness - Alcohol consumption at Week 6 via PEth
timeFrame: Week 6
measure: Exploratory Effectiveness - Alcohol craving reduction at Week 6 via PACS
timeFrame: Week 6
measure: Exploratory Effectiveness - Alcohol craving at Week 12 via PACS
timeFrame: Week 12
measure: Exploratory Effectiveness - Alcohol craving change at Week 6 via VAS
timeFrame: Week 6
measure: Exploratory Effectiveness - Alcohol craving % change at Week 12 via VAS
timeFrame: Week 12
measure: Exploratory Effectiveness - Change in alcohol-related problems at Week 6 via SIP
timeFrame: Week 6
measure: Exploratory Effectiveness - Change in anxiety at Week 12 via BAI
timeFrame: Week 12
measure: Exploratory Effectiveness - Change in depression at Week 12 via PHQ-9
timeFrame: Week 12
measure: Exploratory Effectiveness - Satisfaction with treatment at Week 12 via VAS
timeFrame: Week 12
measure: Exploratory Effectiveness - System Usability at Week 12 via SUS
timeFrame: Week 12
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: TheraNova, LLC
name: KT Venkateswara-Rao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern California Institute of Research and Education
name: David Pennington, PhD
role: PRINCIPAL_INVESTIGATOR
References: