Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Not Applicable

Completed

Brief Summary: This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a pilot investigation in which all participants will receive the active treatment.

Detailed Description: Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.

Recruitment & Eligibility

Inclusion Criteria

Is male or female ≥ 21 year of age at Visit 1
Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment
Endorses Criterion 4 in DSM-5
Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use
Has a breath alcohol concentration of 0.00% at enrollment
Is able to provide informed consent
Is able to understand spoken and written English
Is capable and willing to follow all study-related procedures

Exclusion Criteria

Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage
Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System
Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet.
Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Has used an investigational drug/device therapy within the past 4 weeks
Is deemed unsuitable for enrollment in the study by the PI

Arm && Interventions

Group	Intervention	Description
Active treatment	Empower Neuromodulation System	Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.

Primary Outcome Measures

Name	Time	Method
Change in Mean Number of Alcoholic Drinks Consumed Per Day	Baseline week and Week 2 of the treatment phase	Change in the self-reported average daily consumption over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Number of Participants With Adverse Events	Through study completion, an average of 3 weeks	Safety assessment via device-related adverse events

Secondary Outcome Measures

Name	Time	Method
Decrease in Mean Alcohol Craving Intensity	Baseline week and Week 2 of the treatment phase	Change in self-reported average alcohol craving intensity via 100-mm visual-analog scale (VAS). The VAS has a minimum score of 0 (no craving) and a maximum score of 100 (severe craving). We compared the average daily craving intensity over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Usability	Study completion, at approximately 3 weeks	System Usability Scale (SUS) survey to evaluate usability. The SUS is a 10-item self-report survey (each question is answered on a 5-point Likert scale) which measures usability. An SUS score of 68 is considered average, whereas SUS=80 is the 90th percentile score ("excellent").