Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
NCT ID: NCT03983317
Last Updated: 2020-11-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2019-05-20
2020-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Baseline
For the first week of the study, participants will not administer treatment with the Empower device. Participants will complete surveys to establish baseline values for each participant.
No interventions assigned to this group
Active treatment
Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.
Empower Neuromodulation System
Transcutaneous electrical nerve stimulation
Interventions
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Empower Neuromodulation System
Transcutaneous electrical nerve stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Northern California Institute of Research and Education
OTHER
Theranova, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Jaasma
Role: STUDY_DIRECTOR
Theranova, L.L.C.
Locations
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NCIRE
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRD-12-1176-01
Identifier Type: -
Identifier Source: org_study_id