Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Completed · Not applicable

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT03983317

Run by

Theranova, L.L.C.

People needed

25

Starts

2019-05-20

Expected to finish

2020-03-26

Last updated by the study team

2020-11-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NCIRE — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.