Skip to main content
OpenTrials
Completed

NCT Number: NCT03983317

Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NCIRE

San Francisco, California, 94121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empower Neuromodulation System

Device

Transcutaneous electrical nerve stimulation

Primary outcomes

  1. Change in Mean Number of Alcoholic Drinks Consumed Per Day

    Time frame: 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.

  2. Number of Participants With Adverse Events

    Time frame: Through study completion, an average of 3 weeks

    Safety assessment via device-related adverse events

Secondary outcomes

  1. Decrease in Mean Alcohol Craving Intensity

    Time frame: 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.

  2. Usability

    Time frame: 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").

Sponsors and collaborators

Lead sponsor

Theranova, L.L.C.

Industry

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Northern California Institute of Research and Education

Registry information

Official study title

Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2019
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.