N/A
Completed N=25
Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
Source: ClinicalTrials.gov NCT03983317 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Oct 2020
Primary outcomePrimary: Change in Mean Number of Alcoholic Drinks Consumed Per Day — -1.1 Change in alcoholic drinks per day — p=0.026
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Number of Alcoholic Drinks Consumed Per Day |
-1.1 | 0.026 sig |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| SECONDARY Decrease in Mean Alcohol Craving Intensity |
-13 | 0.001 sig |
| SECONDARY Usability |
76 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03983317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.