Clinical trial NCT03983317: Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
Official title: Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Northern California Institute of Research and Education
First posted: 2019-06-12
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.

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

Primary outcomes:
measure: Change in Mean Number of Alcoholic Drinks Consumed Per Day
timeFrame: Baseline week and Week 2 of the treatment phase
measure: Number of Participants With Adverse Events
timeFrame: Through study completion, an average of 3 weeks
Secondary outcomes:
measure: Decrease in Mean Alcohol Craving Intensity
timeFrame: Baseline week and Week 2 of the treatment phase
measure: Usability
timeFrame: Study completion, at approximately 3 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: NCIRE
state: California
Study officials:
affiliation: Theranova, L.L.C.
name: Michael Jaasma
role: STUDY_DIRECTOR
References: