Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03983317
Study type	Interventional
Source	Theranova, L.L.C.
Contact
Status	Completed
Phase	N/A
Start date	May 20, 2019
Completion date	March 26, 2020

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