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Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

NCT03983317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-11-18

Study results available
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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.

Conditions

Interventions

DEVICE

Empower Neuromodulation System

Transcutaneous electrical nerve stimulation

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Northern California Institute of Research and Education

    collaborator OTHER

  • Theranova, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Michael Jaasma · Theranova, L.L.C.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2020-03-26
Completion
2020-03-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03983317 on ClinicalTrials.gov