Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

Multi-site, double-blinded, prospective, randomized, sham-controlled study

Official Title

Evaluation of the Empower Neuromodulation System for the Treatment of Alcohol Use Disorder

Details

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.

Keywords

Alcoholism, Alcohol Abuse, Alcohol Use Disorder, Alcohol Drinking, Empower Neuromodulation System

Eligibility

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Yale University
    New Haven Connecticut 06516 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Theranova, L.L.C.
ID
NCT05948605
Study Type
Interventional
Participants
Expecting 128 study participants
Last Updated